IMS Company Profiles - Report Buyer

IMS Company Profiles 

Novartis - March 2009

IMS COM PANY PRO FILES NOVARTIS 

Ed i to rial Team 

Nora Mc Car thy - Ex ec u tive Ed i tor 

Selena Class - Dep uty Ex ec u tive Ed i tor 

Su san Murray - Se nior Ed i tor 

Catherine Don nel ly - Ed i tor 

Angie Fra ser - Editor 

Mar ket ing 

Rich ard Derrick 

De sign & Type set ting 

Sophie Avery 

IMS HEALTH 

7 Harewood Av e nue 

Lon don 

NW1 6JB, UK 

Tel: +44 (0)20 3075 5888, Fax: +44 (0)20 3075 5346 

Visit our web site at http://www.imshealth.com 

The In for ma tion Ser vice con tained herein is con fi den tial and pro - 

vided sub ject to the IMS Health In for ma tion Ser vices Stan dard 

Terms and Con di tions. This In for ma tion Ser vice is pro vided to the 

Cli ent on a per sonal ba sis un der a non-ex clu sive and non-trans fer - 

able licence for the Cli ent’s own di rect ben e fit and use only, and 

may not be cop ied or di vulged to any other party. Whilst ev ery pos - 

si ble care has been taken in the prep a ra tion of this in for ma tion, the 

pub lish ers do not hold them selves re spon si ble for any ex pres sions 

of opin ion or er ror or omis sion, or any ac tion re sult ing there from. 

2009 IMS Health In cor po rated or its af fil i ates. All rights re served 

© 2009 IMS Health In cor po rated or its af fil i ates Page 2


IMS Com pany Pro files 

The IMS Com pany Pro files ser vice com prises in di vid ual in-depth re ports cov er ing all as pects of phar ma - 

ceu ti cal cor po ra tions and com pa nies. To gether they build up to pro vide a com pre hen sive ref er ence 

source on the play ers in the in ter na tional healthcare sec tor, whether ac tive in many mar kets, or niche 

play ers; pub lic or pri vate; op er at ing lo cally or world wide. 

Each Pro file aims to give de tailed cov er age of the com pany’s struc ture, strat egy, fi nan cial re sults, re - 

search and de vel op ment pro gram, prod uct port fo lio, and ma jor events. In for ma tion is sourced from in - 

ter views with key ex ec u tives of the com pany, stock bro ker fore casts and com men tary, and pub lished 

in for ma tion. In de pend ent, com pa ra ble sales data on the com pany is in cluded, de rived from IMS 

HEALTH’s da ta base of au dited in ter na tional sales data, MI DAS. 

The ser vice is avail able in a va ri ety of for mats, in clud ing PDF files via e-mail, CD-ROM, on-line (Datastar, 

Di a log and STN) and on the Web. 

For fur ther in for ma tion about the IMS Com pany Pro files ser vice, in clud ing the in for ma tion con tained in 

this Pro file, please call IMS HEALTH on +44 (0)20 3075 5888. 



Ta ble of Con tents 

Cor po rate Struc ture . . . . . . . . . . . . . . . . . . 5 

Strat egy State ment . . . . . . . . . . . . . . . . . . 7 

Fi nan cial Re view . . . . . . . . . . . . . . . . . . . 16 

An a lyst Com ment . . . . . . . . . . . . . . . . 20 

Prod uct Port fo lio . . . . . . . . . . . . . . . . . . . 21 

R&D Pro file . . . . . . . . . . . . . . . . . . . . . 74 

Fi nan cial Data . . . . . . . . . . . . . . . . . . . 108 

Key Fig ures . . . . . . . . . . . . . . . . . . 108 

An a lyst Fig ures . . . . . . . . . . . . . . . . . 112 

IMS Sales Data . . . . . . . . . . . . . . . . . 118 

Em ployee Data . . . . . . . . . . . . . . . . . . . 123 

Li cens ing/Co-Mar ket ing Agree ments . . . . . . . . . 124 

Ma jor Events . . . . . . . . . . . . . . . . . . . . 138 

Novartis Sub sid iary List ing . . . . . . . . . . . . . . 147 

Ap pen dix - Cur rent Com pany Pro files . . . . . . . . . 225 



Corporate Structure 

Head Of fice: Novartis 

CH-4002 Basel 

Swit zer land 

Tel: +41 (61) 324 1111 

Fax: +41 (61) 324 8001 

Home Page: www.novartis.com 

Ex ec u tive Com mit tee: 

Chair man & CEO: Dan iel Vasella 

CFO: Raymund Breu 

Head of Pharmaceuticals: Jo seph Jimenez 

Head of Con sumer Health: Thomas Ebeling 

Head of Sandoz: Andreas Rummelt 

Head of Vac cine and Di ag nos tics: Joerg Reinhardt 

Head of Bio med i cal Re search: Mark C Fishman 

Head of Hu man Re sources: Juergen Brokatzky-Gei ger 

Head of Cor po rate Af fairs: Thomas Wellauer 

Board of Di rec tors: 

Di rec tors: Dan iel Vasella 

Ulrich Lehner 

Hans-Joerg Rudloff 

Pe ter Burckhardt 

Srikant Datar 

Wil liam W George 

Alexandre F Jetzer 

Pi erre Landolt 

Andreas von Planta 

Wendelin Wiedeking 

Mar jo rie Yang 

Rolf M Zinkernagel 

Hon or ary Chair man: Alex Krauer 

Cor po rate Sec re tary: Bruno Heynen 

Source: Novartis An nual Re port 2007/Novartis 2008 

Note: In Oc to ber 2008, Novartis an nounced var i ous or ga ni za tional struc ture and man age ment changes. 

Joerg Reinhardt was ap pointed as the new COO. Re plac ing him as Head of Vac cines and Di ag nos tics is Dr 

Andrin Oswald, cur rently CEO of Speedel and Global Head of Phar ma ceu ti cal De vel op ment Fran chises. The 

Board has ap pointed George Gunn as the new Head of Con sumer Health in ad di tion to his cur rent role as 

Head of the An i mal Health busi ness unit. He will re place Thomas Ebeling, who is leaving Novartis. 

Andreas Rummelt will as sume the newly-cre ated po si tion of Group Head of Qual ity As sur ance and Tech ni cal 

Op er a tions and will re main a mem ber of the Ex ec u tive Com mit tee. Jeff George, cur rently Head of Emerg ing 

Mar kets in the Pharma Di vi sion, will re place him as the new Head of Sandoz. In ad di tion to his role as Head 

of the On col ogy busi ness unit in the Pharma Di vi sion, Da vid Ep stein will also lead a new unit fo cus ing on in - 

no va tive mo lec u lar di ag nos tics. These changes will be come ef fec tive on De cem ber 1, 2008. In ad di tion, 

Thomas Werlen, who serves as Gen eral Coun sel, was named a mem ber of the Executive Committee with 

immediate effect. 

It was also re ported that Wil liam George, a mem ber of the Novartis Board of Di rec tors, has de cided not to 

stand for re-elec tion at the next an nual share holder meet ing. At the next meet ing (sched uled for Feb ru ary 

2009), the Board will pro pose Dr Wil liam Brody, Pres i dent of The Johns Hopkins Uni ver sity and des ig nated 

Pres i dent of the Salk In sti tute, for election. 



Novartis is a com pany with lead er ship po si tions in pat ented and ge neric pharmaceuticals, vac cines, 

and over-the-coun ter med i cines. In 2007, it was ranked as the world’s num ber three phar ma ceu ti cal 

cor po rate group, ac cord ing to IMS. It has four busi ness di vi sions: Pharmaceuticals, Sandoz (Generics), 

Con sumer Health and Vac cines & Di ag nos tics. Based in Basel, Swit zer land, Novartis has un der gone con - 

sid er able re or ga ni za tion in re cent years. Sev eral ac qui si tions have strength ened Novartis’ pres ence in 

vac cines and generics, while the sale of its nu tri tion busi nesses has left the com pany’s fo cus solely on 

healthcare prod ucts. Lead ing drugs are the an gio ten sin II in hib i tor Diovan (valsartan), with 2008 sales of 

$5.7 bil lion, and the can cer ther apy Glivec (imatinib), with 2008 sales of $3.7 bil lion. The com pany’s 

Pharmaceuticals busi ness faced sev eral prob lems in 2007 mainly in the US, in clud ing ge neric com pe ti tion 

and reg u la tory de lays for a ma jor pipe line prod uct, Galvus (vildagliptin), but 2008 saw the sec tor bounce 

back, led by dy namic growth of the on col ogy busi ness. 2008 saw few prod uct launches, but new prod ucts 

launched in 2007 con trib uted sig nif i cantly to growth in 2008. In 2008, Novartis’ vac cines and di ag nos tics 

per formed well, while the per for mance of the generics busi ness was more muted due to a lack of 

launches in the USA. The com pany faces the pros pect of los ing around 20% of its sales to ge neric com pe - 

ti tion by 2012 (in clud ing Diovan). Novartis’ strat egy to sur vive this loss hinges on bol ster ing its ex ten sive 

R&D pipe line, in par tic u lar its on col ogy pipe line, and growth in emerg ing mar kets, as well as con tin ued 

cost-con tain ment mea sures. In 2008 the com pany re ceived 10 key ap prov als and made 14 key reg u la - 

tory sub mis sions (in clud ing ad di tional in di ca tions for mar keted prod ucts) and in 2008 Novartis ac quired 

two com pa nies to bol ster its pipe line: Protez Pharmaceuticals (USA), fo cused on anti-infectives, and 

Speedel (Swit zer land), a de vel oper of car dio vas cu lar drugs. In July 2008, it took a 25% stake in the US 

oph thal mol ogy firm Alcon, which is ma jor ity-owned by Nes tle (Swit zer land), for $10.4 billion. Novartis 

also gained the right to acquire the remaining 52% Alcon stake held by Nestle between January 2010 and 

July 2011 for up to approximately $28 billion. 

Share Data: Shares are quoted on the Swiss stock ex change in Zu rich, and the New York Stock Ex - 

change. Shares are also traded on the SEAQ In ter na tional, Lon don. 

The com pany has the fol low ing busi ness di vi sions: 

Pharmaceuticals 

Sandoz 

Con sumer Health 

Vac cines & Di ag nos tics 



In tro duc tion 

• Strong Per for mance For 2008 

Strategy Statement 

The start of 2009 found Novartis in a pos i tive po si tion in creas ing its div i dends to share hold ers by 25% as 

it re ported strong 2008 re sults, with a 9% rise in to tal sales (5% in lo cal cur rency) and net in come up 

25%. The com pany’s phar ma ceu ti cal busi ness had bounced back from a dif fi cult 2007 and first half of 

2008, and Vac cines and Di ag nos tics and Con sumer Health also con trib uted to growth. The com pany was 

ex tremely pos i tive about its R&D pro duc tiv ity re port ing 14 reg u la tory sub mis sions in 2008 and 10 key 

ap prov als. For the full year 2008 net sales rose to $41.5 bil lion and net in come grew to $8.2 bil lion. Sales 

for the Pharmaceuticals sec tor rose 10% (5% lo cal cur rency) to $26.3 bil lion, sales in Vac cines and Di ag - 

nos tics rose 21% (20% lo cal cur rency) to $1.8 bil lion, sales for Sandoz, the com pany’s generics busi ness, 

rose 5% (1% lo cal cur rency) to $7.6 bil lion and sales in Con sumer Health rose 7% (4% lo cal cur rency) to 

$5.8 bil lion. Al though the US mar ket re mains the com pany’s larg est, ac count ing for 31% of sales, it has 

proved the most dif fi cult in re cent times and growth only re turned in the lat ter half of the year. Dy namic 

growth for the company is now being seen in Eastern and Central Europe and emerging markets. 

There is a ma jor neg a tive ahead for Novartis, how ever, the loss of pat ent pro tec tion for its lead ing prod - 

uct, Diovan (valsartan) in Eu rope in 2011 and in 2012 in the USA. An tic i pat ing this “pat ent cliff”, as it is 

known, Novartis re ports that it is fo cus ing on three ar eas: its on col ogy pipe line, which it plans to ac cel er - 

ate in clud ing new in di ca tions; growth in emerg ing mar kets; and the ac cel er a tion and broad en ing of in di - 

ca tions for 13 ma jor pipe line pro jects in the area Gen eral Med i cines. Novartis also con tin ues to fo cus on 

im proved pro duc tiv ity, cost flow man age ment and bolstering its product portfolio in general. 

In the last de cade, Novartis has sharp ened its fo cus on healthcare. In 2007, it com pleted the di vest ment 

of all its nu tri tion busi nesses. In 2008, the com pany com pleted a se ries of ac qui si tions and in vest ments to 

bol ster its phar ma ceu ti cal busi ness: the pur chase of a 25% stake in the lead ing eye care com pany, Alcon 

(USA), the ac qui si tion of Speedel (Swit zer land) a de vel oper of car dio vas cu lar ther a pies, the ac qui si tion of 

Protez (USA), a de vel oper of anti-infectives, and the ac qui si tion of the pul mo nary busi ness of Nektar 

Ther a peu tics (USA), which will enhance its respiratory drug delivery capabilities. 

Novartis launched the “For ward” ini tia tive in De cem ber 2007 to im prove com pet i tive ness. This ini tia tive 

will sim plify or ga ni za tional struc tures, ac cel er ate and de cen tral ize de ci sion-mak ing pro cesses, re de sign 

the way Novartis op er ates and pro vide pro duc tiv ity gains. Ap prox i mately 2,500 full-time po si tions are 

ex pected to be cut as part of the pro gram. The For ward pro ject pro vided an nual cost sav ings of ap prox i - 

mately $1.1 bil lion in 2008, above the tar get of $670 mil lion. The com pany ex pects fur ther sig nif i cant 

sav ings for 2009 and the fi nal target of $1.6 billion by 2010 is likely to be exceeded. 

In 2008, Novartis CEO Dan iel Vasella has made a num ber of changes to man age ment, no ta bly re plac ing 

Thomas Ebeling as Head of Pharma with Jo seph Jimenez. Mr Jimenez, who joined Novartis from a pri vate 

eq uity firm, had spent most of his ca reer at the food com pany Heinz. Mr Ebeling was moved to head the 

Con sumer Health di vi sion, but in Oc to ber 2008, it was an nounced that he was leav ing the com pany. Dr 

Vasella is also re or ga niz ing R&D and in creas ing his com pany’s in volve ment in the fast-grow ing generics 

and vac cines sec tors. Go ing for ward Novartis an tic i pates seven ap prov als in 2009 (in clud ing ad di tional 

in di ca tions), eight reg u la tory sub mis sions (in clud ing ad di tional in di ca tions) and a large amount of data 

from phase III trials to be reported. 



Re cent years have been dif fi cult for Novartis par tic u larly in 2007 when the com pany went through a com - 

bi na tion of set backs and dis ap point ments that in cluded the un fore seen US ge neric com pe ti tion for four of 

its prod ucts - Lamisil (terbinafine), Trileptal (oxcarbazepine), Famvir (famiciclovir) and Lotrel (amlodipine 

+ benazepril), the with drawal of Zelnorm in many mar kets, and reg u la tory de lays for one of its most 

prom is ing pipe line prod ucts, the antidiabetic Galvus (vildagliptin). And fi nally, the COX-2 in hib i tor 

Prexige (lumiracoxib) re ceived a non-ap prov able let ter from the FDA in Sep tem ber 2007 and has been 

with drawn from several markets due to safety concerns. 

Back ground 

• Re struc tured to Fo cus on Healthcare 

Cre ated in 1996 by the merger of Ciba-Geigy and Sandoz, two Swiss-based chem i cal/life sci ences gi ants, 

Novartis now con cen trates on healthcare. Since 2000, it has spun off its ag ri busi ness unit into a jointly 

held com pany with AstraZeneca and sold its food and bev er age busi ness to As so ci ated Brit ish Foods. In 

2005, Novartis sold the re main der of its for mer Health and Func tional Foods unit, a busi ness called Nu tri - 

tion et Sante, head quar tered in Revel, France. ABN AMRO Cap i tal France bought the unit for 

approximately $260 million. 

In 2006/2007, Novartis sold its Med i cal Nu tri tion unit and Gerber, a baby food busi ness, to Nes tle (Swit - 

zer land) for $2.53 bil lion and $5.5 bil lion, re spec tively. This com pleted Novartis’ di ves ti ture pro gram fol - 

low ing its strat egy to fo cus on healthcare. 

M&A Ac tiv ity 

• Protez, Speedel Ac quired in 2008, Plus Alcon Stake 

Novartis has a very ac tive M&A pro file. In June 2008, it ac quired the pri vate US biotech com pany Protez. 

Protez is de vel op ing PZ 601, a new carbapenem an ti bi otic in phase II tri als in the treat ment of pa tients 

with com pli cated skin and skin struc ture in fec tions. PZ 601 is a 1-beta-methylcarbapenem with an ex - 

tended spec trum of ac tiv ity against multidrug-re sis tant Gram pos i tive patho gens, in clud ing MRSA, and 

Gram negative bacteria. 

In July 2008, Novartis took a 25% stake in the US oph thal mol ogy com pany Alcon, which is ma jor - 

ity-owned by Nes tle (Swit zer land), for $10.4 bil lion. Novartis also gained rights to ac quire the re main ing 

52% Alcon stake held by Nes tle be tween Jan u ary 2010 and July 2011 for up to ap prox i mately $28 billion. 

Also in July 2008, Novartis be came the ma jor ity owner of Speedel Hold ings Ltd (USA), fol low ing the ac - 

qui si tion of an ad di tional 51.7% stake. A man da tory pub lic ten der of fer be gan in Au gust 2008 to buy the 

re main ing shares in the com pany. Novartis states that to tal ac qui si tion costs are es ti mated at around 

$880 mil lion. Novartis has a long-stand ing col lab o ra tion with Speedel and states that Speedel’s R&D 

pipe line is a strong fit with its lead ing po si tion in cardiovascular disease. 

An a lysts have been di vided on the wis dom of the Alcon pur chase. Some view it as a strong de fen sive 

move by Novartis, which makes a great deal of sense as it faces a num ber of ma jor pat ent ex pi ries, as 

Alcon is a ma jor force in the mar ket for vi sion-re lated sur gi cal prod ucts and strong in con sumer prod ucts 

such as eye drops and con tact lens care. And Dan iel Vasella, Novartis’ CEO has said that he ex pects 

Alcon’s busi ness to ben e fit from the world’s ag ing pop u la tion, given that eye prob lems such as glau coma 

and cat a racts are more com mon in the el derly. But oth ers have noted that in ac cept ing Nes tle’s wish to 

sell the busi ness in two steps in stead of one sin gle trans ac tion, Novartis will not be able to take full ad van - 

tage of the ac qui si tion and ex ploit syn er gies with its ex ist ing CIBA Vi sion oph thal mol ogy busi ness un til 

2010 at the ear li est, while at the same time, it is com mit ting a large amount of cap i tal to a busi ness which 



it does not con trol. Dr Vasella notes that CIBA Vi sion is the world’s sec ond-larg est con tact lens care com - 

pany, while Alcon is not in volved in the con tact lens busi ness. Also, Novartis sells two drugs for age-re - 

lated macular de gen er a tion, an area in which Alcon has no in volve ment, and Alcon has sur gi cal, 

consumer and prescription products in areas where CIBA Vision does not operate. 

In Au gust 2008, Natixis Bleichroeder an a lysts noted, “Alcon is the world leader in oph thal mol ogy, a 

fast-grow ing mar ket where ge neric risk is more con tained and where syn er gies with Novartis’ oph thal - 

mol ogy busi ness should be sub stan tial.” An a lysts at Bernstein Re search (Au gust 2008) noted that 

Novartis will hit a real “pat ent ex piry cliff” in 2011-12. In 2012, its ma jor drug Diovan (sales of around $5 

bil lion in 2007) will lose ex clu siv ity, which will be a se vere blow to the com pany. Look ing at the Alcon deal, 

they com mented, “While the deal was felt by many as ex pen sive, such is the case with nearly all as sets 

for sale in the cur rent phar ma ceu ti cal en vi ron ment. As the ‘cliff’ draws near we think as set prices could 

con tinue to rise as more com pa nies be come more des per ate; the ac qui si tion price on Alcon may well 

have risen higher as time elapsed.” 

Re gional Strat egy 

• Emerg ing Mar kets Tar geted 

Al though the US re mains an im por tant mar ket for Novartis, pro vid ing 31% of sales in 2008 (34% in 

2007), it has be come in creas ingly dif fi cult over re cent times, with tough ge neric com pe ti tion and an in - 

creas ingly con ser va tive reg u la tory en vi ron ment. Al though growth re turned to the US mar ket in the sec - 

ond half of 2008, it did not coun ter the neg a tive growth in the first half of the year and the re sult was a 

1.6% drop in sales for the full year to $12,861 mil lion, com pared to sales from con tin u ing op er a tions of 

$13,074 mil lion in 2007. In com par i son, for 2008 Novartis re ported solid growth in Eu rope, Latin Amer - 

ica, Ja pan and emerg ing mar kets, with China and Rus sia both de liv er ing more than 30% growth. Over all 

growth out side the USA amounted to 14.4% and sales out side the US represented 69% of total sales or 

$28,598 million. 

Novartis is re struc tur ing it US salesforce and mak ing cut backs, with 550 rep po si tions be gin ning in Jan u - 

ary 2009. The new struc ture will have five pri mary care-fo cused re gional op er at ing units and one na - 

tional spe cialty phar ma ceu ti cal business unit. 

Novartis has been tak ing steps to in crease its pres ence in seven key emerg ing mar kets (Brazil, China, In - 

dia, Mex ico, Rus sia, South Ko rea and Tur key), and in other emerg ing mar kets. In 2008, Jo seph Jimenez, 

Head of Pharmaceuticals, noted “you are go ing to see us shift our cen ter of grav ity to ward some of the 

faster-grow ing mar kets, sig nif i cantly ex pand the size of our sales forces and step up clin i cal de vel op ment 

ac tiv i ties in an ef fort to take busi nesses al ready grow ing rap idly to even higher lev els.” By 2020 Novartis 

ex pects the emerg ing mar kets to ac count for 20% of the com pany’s to tal global pre scrip tion drug sales, 

an in crease from 8% at pres ent. In the seven pri or ity coun tries, Brazil, China, In dia, Mex ico, Rus sia, 

South Ko rea and Tur key, sales in 2008 rose 18% in lo cal cur rency terms to $4.3 bil lion. Emerg ing mar - 

kets across the world gen er ated net sales growth of 13% in lo cal cur rency terms to $10 bil lion, stand ing 

at about 24% of total net sales, compared to 22% in 2007. 

An other ma jor stra te gic aim for Novartis is that of boost ing its ac tiv i ties in grow ing Asian mar kets. 

Novartis has con sid er ably strength ened its sales force in Ja pan in re cent years and it is among the top 10 

drug com pa nies in that mar ket. An im por tant launch in Ja pan was that of Diovan (launched in No vem ber 

2000), which is now the num ber two prod uct in the AIIA class in that mar ket, be hind Blopress. The an gio - 

ten sin II in hib i tor class has grown strongly in Ja pan in re cent years, as these newer prod ucts have taken 

mar ket share from older ther a pies. In July 2008, Mr Hiroyuki Mitani, Pres i dent and CEO of Novartis 

Pharma KK, stated that 2008 is an im por tant year for Novartis in Ja pan as it pre pares for the launch of 

seven or eight new prod ucts from 2009. In Jan u ary 2009, Novartis re ported that four drugs had re ceived 

ap proval in Ja pan: the can cer treat ment Tasigna (nilotinib); the asthma treat ment Xolair (omalizumab); 



Co-Diovan (valsartan + HCTZ) for hy per ten sion; and the wet age-re lated macular de gen er a tion drug 

Lucentis (ranibizumab). Sales in Japan in 2008 were $2,987 million. 

Novartis is also very pos i tive about the Chi nese mar ket. In 2008 sales in China were $456 mil lion. The 

com pany’s to tal in vest ment in China now to tals over $400 mil lion, with two ma jor de vel op ments an - 

nounced in 2006: a man u fac tur ing and de vel op ment cen ter in Changshu, and an in te grated bio med i cal 

R&D cen ter in Shang hai. The re search fa cil ity will fo cus ini tially on dis cov er ing med i cines to treat can cers 

caused by in fec tions, which make up a con sid er able pro por tion of the can cer cases di ag nosed in China. 

Few groups have con ducted ba sic drug dis cov ery work in China be cause of con cerns about in tel lec tual 

prop erty pro tec tion. In No vem ber 2008 Novartis was re ported to be in creas ing its in vest ment in this re - 

search cen ter and in creas ing its mar ket ing team by 20%. Novartis plans to ex pand in both its eth i cal and 

OTC busi ness and there have been re ports that the com pany is seek ing to ac quire a Chi nese OTC com - 

pany. The goal is a 30-40% an nual in crease in its busi ness in China for the next five to ten years, ac cord - 

ing to Jeffrey Li, Novartis’ China Pres i dent. Novartis currently ranks as the fourth largest pharmaceutical 

company in the Chinese hospital market. 

Ther a peu tic Fo cus 

• Key Growth Driv ers: Car dio vas cu lar & On col ogy 

Novartis is in an un usual po si tion of run ning both a generics and an in no va tive R&D com pany, which it 

does suc cess fully with sep a rate boards of man age ment and thus avoid ing the ob vi ous ideo log i cal dif fer - 

ences be tween the two con cepts. This strat egy also aims to pro long the lifecycle of its pro pri etary 

pharmaceuticals when they come off pat ent al though would have to be care ful not to en ter into obvious 

competition issues. 

Novartis’ Phar ma ceu ti cal Di vi sion is com prised of the fol low ing ther a peu tic ar eas: car dio vas cu lar; on col - 

ogy; neu ro sci ence; re spi ra tory; ophthalmics, der ma tol ogy, gas tro in tes ti nal and urol ogy; ar thri tis/bone; 

and in fec tious dis eases, transplantation and immunology. 

In 2008, Novartis’ port fo lio in cluded five block bust ers and was led by Diovan, for hy per ten sion, with sales 

of $5.7 bil lion. In sec ond po si tion was Gleevec/Glivec (imatinib), for chronic myeloid leu ke mia, launched 

in 2001, with sales of $3.7 bil lion, with Zometa (zoledronic acid), used in treat ing bone prob lems as so ci - 

ated with can cer and os teo po ro sis, in third place with sales of $1.4 bil lion. Femara (letrozole) for breast 

can cer be came the com pany’s fourth block buster in 2008 with sales of $1.1 bil lion, fol lowed by 

Sandostatin (octreotide), for acromegaly, in fourth place, also with $1.1 billion in sales. 

New prod ucts that have per formed par tic u larly well in 2008 con trib ut ing $2.9 bil lion to sales over all, in - 

clude Lucentis (ranibizumab) for the treat ment of age-re lated macular de gen er a tion, sales up 125% to 

$886 mil lion, Exjade (deferasirox) for iron over load up 49% to $531 mil lion, and Exforge (valsartan + 

amlodipine) for hy per ten sion up 294% to $406 mil lion. Sales of the com pany’s lead ing Alz hei mer’s drug 

Exelon (rivastigmine) have been re vived by the launch of the Exelon Patch and sales were up 29% to 

$815 mil lion. The com pany has not had any new ma jor launches in 2008 but com pleted 14 ma jor sub - 

mis sions in the US, Eu rope and Ja pan, with 2009 poised to be a big year for launches. 

A re cent im por tant launch for the com pany was Tekturna (aliskiren), a di rect renin in hib i tor for the treat - 

ment of hy per ten sion. Novartis is re ported to be in vest ing heavily in de vel op ing this drug, with a ma jor 

global tri als pro gram un der way and two com bi na tion prod ucts al ready close to mar ket: Tekturna plus 

Diovan and Tekturna plus the di uretic hy dro chlo ro thi a zide. Novartis hopes that Tekturna will achieve 

sales of more than $1 billion annually. 

In 2003, Novartis united its generics ac tiv i ties un der a sin gle global name: Sandoz. Ranked as the sec - 

ond-larg est generics com pany in the world based on sales, Sandoz has made a se ries of tar geted ac qui si - 



tions to strengthen its prod uct port fo lio, tech no log i cal ex per tise, and geo graphic pres ence, led by the 

ac qui si tions of Hexal and Eon Labs in 2005. The busi ness has grown well but in 2008 net sales rose just 

5.4% to $7.6 bil lion, tem pered by the lack of new launches in the USA. 

In 2006, Sandoz’s re com bi nant hu man growth hor mone Omnitrope (somatropin) be came the first bi o - 

logic fol low-on prod uct (biosimilar) to be ap proved un der a new biosimilar path way in the EU. It was also 

ap proved in the USA in 2006. Sandoz is now step ping up its at tack on the biotech mar ket. In 2007, it re - 

ceived Eu ro pean ap proval for Binocrit (epoetin alfa), a biosimilar ver sion of Amgen’s Epogen and J&J’s 

Procrit, which has now been launched in a num ber of mar kets. 2008 saw the ap proval in Eu rope of 

Extavia (in ter feron beta-1b), a biosimilar ver sion of Bayer’s Betaseron/Betaferon for mul ti ple scle ro sis. It 

was launched in Ger many and Den mark in Jan u ary 2009, with fur ther Eu ro pean launches planned for 

2009 as well as a US launch. And in Feb ru ary 2009, Sandoz gained ap proval from Eu ro pean reg u la tors for 

a fourth biosimilar med i cine, Zarzio/Filgrastim Hexal (filgrastim). In its 2008 an nual re port, Novartis 

noted that the Sandoz de vel op ment pro gram for biosimilars in cludes 25 pro jects, one of the broad est 

pro grams in the in dus try. The Kundl (Aus tria) site is one of the big gest de vel op ment and man u fac tur ing 

centers for microbially expressed recombinant proteins. 

Dr Gehard Schaefer, Head of Global Prod uct De vel op ment at Sandoz stated in the Novartis 2007 an nual 

re port, “This is the be gin ning of a con stant flow of fol low-on prod ucts com ing out of our bio tech nol ogy de - 

vel op ment.” He noted that Sandoz sci en tists are now as sess ing sec ond-gen er a tion, long-act ing bio tech - 

nol ogy prod ucts as pos si ble pro jects. An other ma jor fo cus will be fol low-on ver sions of monoclonal 

an ti bod ies that will be gin los ing pat ent pro tec tion in about five years. Dr Schaefer stated, “This is the fu - 

ture and as one of the ma jor play ers in the field we clearly are looking into these opportunities.” 

On a less pos i tive note for Sandoz, there have been me dia re ports of other large com pa nies mov ing in to 

the area of biosimilars, in clud ing Merck & Co and Lilly. The lat ter has just ex panded its biotech ca pa bil ity 

with the pur chase of ImClone Sys tems (USA). 

Sandoz notes that dur ing 2008, it sub mit ted reg u la tory ap pli ca tions for 1,500 dif fer ent pro jects to au - 

thor i ties around the world, as well as sub mit ting sup ple men tary reg u la tory ap pli ca tions in new mar kets 

for many ex ist ing prod ucts, part of a growth ini tia tive prompted by the ac qui si tion of Hexal and Eon. 

Sandoz also has a deep pipe line, en com pass ing more than 880 pro jects, in clud ing a sig nif i cant proportion 

of difficult-to-make products. 

R&D 

• 152 Clin i cal Pro jects in the Pipe line 

Novartis has a large R&D pipe line, with pro jects in clud ing both new mo lec u lar en ti ties and ad di tional in di - 

ca tions or for mu la tions for mar keted prod ucts. Over all, Novartis stated that it had 152 pro jects in clin i cal 

de vel op ment in Jan u ary 2009, and that in 2008 it had made 14 reg u la tory sub mis sions and had re ceived 

10 key ap prov als. In 2008, Novartis in vested $7.2 bil lion in group R&D activities, up 12%. 

Key ar eas of de vel op ment are on col ogy and car dio vas cu lar dis eases. In on col ogy, Novartis hopes to 

launch five new drugs by 2012, and be lieves that at least one could achieve sales of $1 bil lion or more an - 

nu ally. In Sep tem ber 2008, its prod uct Afinitor (everolimus) was granted Pri or ity Re view sta tus by the US 

FDA for the treat ment of pa tients with ad vanced kid ney can cer af ter fail ure of stan dard treat ment. In No - 

vem ber 2008 the FDA re quested more in for ma tion, but Novartis still an tic i pates a 2009 ap proval. 

Novartis has also filed MAAs for Afinitor with the EMEA and the Swiss Agency for Ther a peu tic Prod ucts 

(Swissmedic). Everolimus is also in late-stage tri als for other types of can cer (it is al ready mar keted as 

Certican for the pre ven tion of or gan trans plant re jec tion). The other com pounds are vadimezan (ASA 

404), in de vel op ment in part ner ship with Antisoma (UK) for non-small cell lung can cer with a fil ing sched - 

uled for 2011, pasireotide (SOM 230) for a rare group of neuroendocrine tu mors with a fil ing sched uled 



for 2010, panobinostat (LBH 589), which is be ing stud ies in cu ta ne ous T-cell lym phoma and pros tate 

can cer with a fil ing planned for 2009, and midostaurin (PKC 412), a pro tein kinase in hib i tor, for acute 

myeloid leu ke mia, with a fil ing planned for 2011. Novartis has a broad range of com pounds in de vel op - 

ment in other ther a peu tic ar eas, such as neu rol ogy, trans plan ta tion, re spi ra tory dis eases, oph thal mol - 

ogy, and in fec tious dis eases, an area that has grown in im por tance for the com pany. Other re cent 

reg u la tory fil ings were the once daily long-act ing beta ag o nist indacaterol (QAB 149) in the USA and Eu - 

rope for the treat ment of COPD, and the hu man monoclonal an ti body to interleukin-1 beta, ACZ 885, for 

the treat ment of Cryopyrin-As so ci ated Pe ri odic Syn dromes (CAPS) in the USA and Eu rope. In 2009-10, 

Novartis should also launch two new meningitis vaccines (Menveo and MenB), which could be potential 

blockbusters, and the Japanese encephalitis virus vaccine, Ixiaro. 

Novartis has also been build ing its po si tion in biologics, con sis tently grow ing its ca pa bil i ties and ex per tise 

in the R&D of all bi o logic ther a pies, which now rep re sent 25% of the pre clin i cal re search port fo lio. In 

2007, Novartis formed the Novartis Biologics Unit, to unify its core ca pa bil i ties in biologics within one 

group. 

In De cem ber 2008, Novartis com pleted the ac qui si tion of the pul mo nary drug de liv ery busi ness of Nektar 

(USA). It ac quired spe cific pul mo nary de liv ery as sets, tech nol ogy, and in tel lec tual prop erty from Nektar 

for $115 mil lion in cash. Cer tain dry pow der and liq uid pul mo nary for mu la tion and man u fac tur ing as sets 

(in clud ing cap i tal equip ment and man u fac tur ing cap i tal lease ob li ga tions) have also been ac quired by 

Novartis. Novartis will also take on 140 Nektar per son nel, as well as cer tain in tel lec tual prop erty and 

man u fac tur ing meth ods. Man u fac tur ing and roy alty rights to tobramycin in haled pow der (In haled Tobi), 

which is in phase III trials, will be transferred to Novartis. 

Pat ent Is sues 

• Im por tant Prod ucts at Risk 

In 2007, sales of four Novartis phar ma ceu ti cal prod ucts, Lotrel, Lamisil, Trileptal and Famvir, were neg a - 

tively af fected by the start of ge neric com pe ti tion in the US, which in some cases was un ex pected. These 

four prod ucts had com bined 2006 an nual net sales of around $2.6 bil lion in the US. As a re sult of ge neric 

com pe ti tion, com bined net sales in 2007 for these prod ucts de clined 38% to $1.6 bil lion, and de clined 

sig nif i cantly fur ther in 2008 (Lotrel down 48% and Trileptal down 52%). The sharp and sig nif i cant re duc - 

tion in net sales of these prod ucts had an ad verse ef fect on the 2007 re sults of op er a tions of the 

Pharmaceuticals Di vi sion. Novartis re ported that the ef fect was still sig nif i cant in the first half of 2008 in 

the USA, but less so in the lat ter half with growth in the Pharmaceuticals area returning. 

Other Novartis pharma prod ucts that are the sub ject of on go ing US pat ent lit i ga tion in clude Femara 

(breast can cer), Lescol (high cho les terol), Focalin/Ritalin LA (ADHD) and Comtan/Stalevo (Par kin son’s 

dis ease). The loss of ex clu siv ity of some of these prod ucts could have a sig nif i cant ad verse ef fect on the 

re sults of op er a tions of the Pharmaceuticals Di vi sion. There was a de vel op ment in the Femara lit i ga tion in 

De cem ber 2008, how ever, when Novartis and Mylan en tered a set tle ment agree ment, un der which 

Mylan has a pat ent li cense that will en able it to mar ket letrozole tab lets 2.5 mg prior to the ex pi ra tion of 

the pat ent. Ad di tional terms of the agree ment re main un dis closed. In ad di tion, Neoral (trans plan ta tion) 

and Voltaren (pain), which are still among Novartis’ top ten prod ucts and had com bined net sales of $1.8 

bil lion in 2008, have al ready en coun tered ge neric com pe ti tion in many markets, which may cause sales 

to decline significantly in the future. 

A num ber of other ma jor prod ucts, in clud ing Diovan, Gleevec/Glivec and Zometa, could also po ten tially 

face ge neric com pe ti tion in the com ing years in var i ous mar kets, par tic u larly the US and Eu rope, ei ther 

due to po ten tial pat ent chal lenges or the reg u lar ex pi ra tion of pat ents. Diovan, Glivec and Zometa had 

com bined net sales of $10.8 bil lion in 2008. Al though the loss of ex clu siv ity of any one of these three 

prod ucts could have a sig nif i cant ad verse ef fect on Novartis’ fi nan cial per for mance, it is the loss of Diovan 



with its $5.7 bil lion in an nual sales that has been high lighted by the com pany as fuel ing its strat egy over 

the next few years (see In tro duc tion). Diovan loses pat ent protection in Europe in 2011 and in the USA in 

2012. 

Fu ture Pros pects 

• Re cord Year Ex pected for 2009 

In Jan u ary 2009 Novartis noted that it ex pects an other year of re cord net sales and earn ings in 2009. The 

Group’s net sales are ex pected to grow at a mid sin gle-digit rate in 2009, while Pharmaceuticals net sales 

are ex pected to grow at a mid-to high sin gle-digit rate (in lo cal cur ren cies). 

Novartis faces a ma jor chal lenge over the next few years, mak ing up for the po ten tial loss of $5 bil lion in 

sales from its lead ing drug Diovan when its pat ent ex pires in the USA in 2012. The chal lenge might even 

come ear lier than that, as in 2010 the ri val drug Merck & Co’s Cozaar (losartan) loses pat ent pro tec tion 

and a ge neric ver sion of losartan will ap pear, giv ing in sur ers a cheaper op tion than Diovan. In ad di tion, 

sev eral other of Novartis’ lead ing drugs lose pat ent pro tec tion at ap prox i mately the same time, af fect ing 

about 21% of the com pany’s rev e nue. Novartis notes that it is tak ing a multi-fac eted ap proach, in clud ing 

de vel op ment of its pipe line of on col ogy drugs and ex pand ing in the high growth emerg ing mar kets. It is 

also, how ever, in vest ing a lot in de vel op ment of its new car dio vas cu lar drug Tekturna (aliskiren), which is 

be ing rolled out world wide, but is also in a large global clin i cal tri als pro gram and be ing de vel oped as a 

com po nent of com bi na tion prod ucts, with two of these close to the mar ket — Tekturna plus Diovan and 

Tekturna plus the di uretic HCTZ. De spite the in vest ment, Joe Jimenez, noted in De cem ber 2008 that 

even if the data on Tekturna is pos i tive, it is un likely to be pos si ble to build a Diovan-sized brand, but 

Novartis does be lieve the drug can achieve sales of more than $1 bil lion a year. In 2009 Novartis an tic i - 

pates seven ap prov als in 2009 (in clud ing ad di tional in di ca tions), seven sub mis sions for ap proval (in clud - 

ing ad di tional in di ca tions) and a con sid er able amount of phase III data. Novartis is hop ing for ap proval of 

the on col ogy prod uct Afinitor (everolimus), the men in gi tis vac cine Menveo, two com bi na tion prod ucts 

with Tekturna (with Diovan and with HCTZ) and Exforge plus HCTZ, as well as ap proval of Glivec for ad di - 

tional in di ca tions. No ta ble sub mis sions should be fingolimod (FTY 720), an oral treat ment of multiple 

sclerosis, MFF 258 (formoterol + mometasone) for asthma and COPD, Albuferon (albinterferon alfa-2b) 

for hepatitis C. 

Novartis’ re mains among an a lysts fa vor ites in the Pharmaceuticals sec tor, as it has im pressed with cost 

con trols and its strong prod uct pipe line. An drew Weiss of the Swiss Bank Vontobel noted that com pared 

to its peers Novartis has one of the full est pipe lines of new drugs in de vel op ment, but a ques tion hangs 

over whether the pipe line will ma te ri al ize in time be fore the pat ent ex pi ries be gin. Of in ter est to Mor gan 

Stan ley an a lysts is the com pany’s on col ogy pipe line, its new oral drug for MS, FTY 720, and the po ten tial 

for Zometa to show sig nif i cant growth with new indications. 

In vest ing heavily in the emerg ing mar kets is a strat egy that many of the com pany’s peers are also tak ing, 

how ever me dia com men ta tors have noted that growth is be gin ning to slow in these mar kets, af fected by 

the slow down in the de vel oped mar kets and these mar kets may not of fer the same kind of growth po ten - 

tial as they once did. 

In Jan u ary 2009, an a lysts at Cowen & Co and Mor gan Stan ley were dis ap pointed by Novartis’ Q4 re sults 

as Novartis had re ported sig nif i cantly lower-than-ex pected EPS and lack lus ter rev e nues, both sets of an - 

a lysts, how ever, were more pos i tive about the lon ger term, with those at Cowen & Co not ing that the 

“out look re mains ro bust” and that they “con tinue to be lieve that NVS should de liver top-tier growth 

through 2015.” Cowen & Co noted that the Phar ma ceu ti cal and Vac cines busi nesses dem on strated good 

mo men tum, but that Sandoz and Consumer “continue to face headwinds.” 



Events with Major Potential Impact for Novartis 

EVENT SUMMARY 

Competition for Diovan Diovan is set to lose patent protection in Europe in 2011 (September 

2012 in USA). At this point it stands to lose nearly $5 billion in sales. 

However the first test will be in 2010 when rival product Cozaar 

(losartan) loses patent protection in the USA and cheap generic losartan 

products will be launched. Morgan Stanley analysts give peak Diovan 

sales in 2010 of $5.8 billion falling to almost $1.3 billion by 2012. 

Potential generic 

competition in the US 

Ongoing generic 

competition in the US 

Femara, Lescol, Focalin/Ritalin LA and Comtan/Stalevo are subject of 

ongoing US patent litigation. The loss of exclusivity of some of these 

products could have a significant adverse effect on Novartis’ results. In 

December 2008 Mylan and Novartis settled patent litigation allowing 

Mylan to launch a generic Femara prior to patent expiry, but few details 

of the agreement were disclosed. 

Generic competition for Lotrel, Lamisil, Famvir and Trileptal in the US 

started in 2007. These four products had combined 2006 annual net 

sales of around $2.6 billion in the US. As a result of generic competition, 

combined net sales in 2007 declined 38% to $1.6 billion, and declined 

even further in 2008. In addition, Neoral and Voltaren, which are still 

among Novartis’ top ten products and had combined net sales of $1.8 

billion in 2008, have encountered generic competition in many markets, 

which may cause sales to decline significantly in the future. 

Zelnorm withdrawal The IBS therapy Zelnorm was withdrawn from the US market in 2007 

due to safety concerns. Subsequently other countries also requested its 

withdrawal. It could return to the market but analysts think sales would 

be low because of negative publicity. Zelnorm sales fell from over $500m 

in 2006 to $88m in 2007. Annual sales around $13 million are now 

anticipated by analysts. 

Galvus delayed in the US Novartis is continuing discussions with the FDA on steps needed for 

approval of its Type 2 diabetes drug Galvus following an approvable 

letter in February 2007 that included a request for additional clinical 

data. A US resubmission is not expected before 2010. 

New product 

launches/Acquisition of 

new companies 

Novartis had 15 positive regulatory decisions in 2007 in the US and 

Europe. These include Tekturna/Rasilez, Lucentis, Exforge, Exelon Patch, 

Aclasta/Reclast, Tasigna, Tyzeka/Sebivo, Lucentis, and Galvus. These 

new products contributed $2.9 billion to sales in 2008 and are expected 

to continue to fuel growth. Combined with the 2008 Alcon, Speedel and 

Protez acquisitions, these new product launches should help offset loss of 

sales from products going off patent. In 2008, Novartis made 14 major 

regulatory submissions, led by Afinitor, QAB 149, ACZ 885 and Menveo. 



EVENT SUMMARY 

Heavy investment in 

vaccines 

Biosimilars: a good 

opportunity for Novartis 

Source: IMS Com pa nies 

Novartis plans to invest up to $2bn over the next five years in an effort 

to turn its vaccines business into one of the world’s top three operators. 

It wants to become a global leader in meningitis vaccines and one of the 

top two manufacturers of flu and travelers’ vaccines by 2012. The Chiron 

purchase has positioned it among the top five global vaccine makers with 

special expertise in the growing area of flu vaccines. Novartis believes 

the vaccine industry will grow 20% annually over the next 5 years. 

Analysts forecast strong growth for the vaccines business. In 2009-10, 

Novartis should launch two new meningitis vaccines (Menveo and 

MenB), which could be potential blockbusters. 

The growth hormone Omnitrope (somatropin) received EU and US 

approvals in 2006 and was the first biosimilar to reach the market, 

opening the door to other biosimilar products. Sandoz is prepared to 

exploit this market; it has a number of other biosimilars in development 

and is studying new opportunities in the field. In 2007, it received 

European approval for an EPO biosimilar, Binocrit (epoetin alfa), which 

has since been launched in a number of markets. In 2009, its biosimilar 

branded interferon beta-1b (Extavia) was launched on its first markets in 

Europe; a US submission is planned for 2009. February 2009 also saw 

EU approval for a biosimilar version of filgrastim, Zarzio/Filgrastim Hexal. 



Net Sales 

Financial Review 

Group sales rose 8.9% to $41,459 mil lion in 2008, with growth led by Pharmaceuticals, sup ported by 

Vac cines and Di ag nos tics and Con sumer Health. Higher vol ume sales pro vided six per cent age points of 

growth and cur rency ef fects added an other four per cent age points. 

$ millions 

45,000 

40,000 

35,000 

30,000 

25,000 

20,000 

15,000 

10,000 

5,000 

0 

Net Profit 

Company Sales 

2004 2005 2006 2007 2008 

Source: Novartis January 2009/Novartis Annual Reports 

Net profit in 2008 was $8,163 mil lion, up 24.8% from the fig ure for net profit from con tin u ing op er a tions 

in 2007 of $6,540 mil lion. The net profit fig ure for 2007 was $11,968 mil lion with dis con tin ued op er a tions 

(Gerber and Med i cal Nu tri tion) in cluded, and so net profit for 2008 com pared to this fig ure was down 

31%. Net in come in 2008 was af fected by the fi nanc ing costs in July 2008 of Novartis’ ac qui si tion of 25% 

of Alcon (USA). 

$ millions 

12,000 

10,000 

8,000 

6,000 

4,000 

2,000 

0 

Net Profit 

2004 2005 2006 2007 2008 




Earnings per Share 

Based on net in come from con tin u ing op er a tions di luted earn ings per share (EPS) in 2008 was $3.59, up 

28% from $2.81 in 2007. A di rect com par i son in clud ing dis con tin ued op er a tions re sults in a re duc tion in 

EPS of 30% from 2007 to 2008. 

$ 

6.0 

5.0 

4.0 

3.0 

2.0 

1.0 

0.0 

R&D Costs 

Earnings Per Share 

2004 2005 2006 2007 2008 


In 2008, Novartis in creased R&D spend ing by 12.2% to $7,217 mil lion, rep re sent ing 17.4% of sales, up 

from 16% in 2007. 

$ millions 

8,000 

7,000 

6,000 

5,000 

4,000 

3,000 

2,000 

1,000 

0 

Sales by Business Sector 

R&D Costs 

2004 2005 2006 2007 2008 


Pharmaceuticals ac counted for 63.5% of Novartis net sales from con tin u ing op er a tions in 2008, Sandoz 

for 18.2%, Con sumer Health for 14% and Vac cines and Di ag nos tics for 4.2%. Pharmaceuticals net sales 

were up 9.6% (5% in lo cal cur rency terms) to $26.3 bil lion. The On col ogy and Car dio vas cu lar fran chises 

pro vided dy namic per for mances, in clud ing Diovan with sales of $5.7 bil lion and Glivec with $3.7 bil lion. 

Sales of $2.9 bil lion came from re cently launched prod ucts in clud ing Aclasta/Reclast, Tekturna, Exforge, 

Lucentis, Exelon Patch, Tasigna and Xolair. 



Vac cines and Di ag nos tics net sales to taled $1.8 bil lion, up 21.1% (20% in lo cal cur rency terms), with 

per for mance driven by de liv er ies of H5N1 pan demic in flu enza vac cines to the US gov ern ment and steady 

growth in di ag nos tics. Fur ther growth came from the sale of com po nents for use in pediatric vaccines. 

Sandoz sales were up 5.4% (1% in lo cal cur rency terms) to $7.6 bil lion. Im proved per for mances in many 

mar kets were off set by a 10% drop in the US mar ket to $1,766 mil lion due to a lack of new prod uct 

launches in 2008: sales in the rest of the world rose 5% in lo cal cur rency terms to $5,791 million. 

Sales from con tin u ing op er a tions in the Con sumer Health di vi sion in creased 7.1% (4% in lo cal cur rency 

terms) to $5.8 bil lion. The OTC busi ness grew strongly in emerg ing mar kets, but US sales fell. An i mal 

Health growth came from ex pan sion in the com pan ion animals business. 

$ millions 

30,000 

25,000 

20,000 

15,000 

10,000 

5,000 

0 

Sales by Business Sector 

2006 2007 2008 


Sales by Therapeutic Class 

Car dio vas cu lar fran chise sales grew 10.5% in 2008 to $8.2 bil lion. On col ogy per formed well, with an 

18.1% in crease to $8.2 bil lion. Neu ro sci ence and Ophthalmics sales were up 5.9% at $4.6 bil lion. Re spi - 

ra tory sales rose 13% to $1,084 mil lion. Sales in Im mu nol ogy and In fec tious Dis eases amounted to 

$2,954 mil lion, down slightly on $2,993 million in 2007. 

$ millions 

Pharmaceuticals Vaccines and Diagnostics Sandoz Consumer Health 

9,000 

8,000 

7,000 

6,000 

5,000 

4,000 

3,000 

2,000 

1,000 

0 

Sales by Therapeutic Class 

2006 2007 2008 


Cardiovascular Oncology Neuroscience Respiratory 

Ophthalmics Arthritis/Bone Infect Diseases 



Sales by Geographical Region 

For 2008 Novartis re ported solid growth in Eu rope, Latin Amer ica, Ja pan and emerg ing mar kets, with 

China and Rus sia both de liv er ing more than 30% growth. In the high-growth mar kets of, Brazil, China, 

In dia, Mex ico, Rus sia, South Ko rea and Tur key, sales rose 18% in lo cal cur rency terms to $4.3 bil lion. 

Emerg ing mar kets across the world gen er ated net sales growth of 13% in lo cal cur rency terms to $10 bil - 

lion, ris ing to rep re sent 24% of net sales in 2008, com pared to 22% in 2007. Over all growth out side the 

USA amounted to 14.4% and sales out side the US rep re sented 69% of to tal sales or $28,598 mil lion. In 

the USA growth only re turned in the sec ond half of the year re sult ing in a 1.6% drop in sales for the full 

year to $12,861 mil lion, com pared to sales from con tin u ing op er a tions of $13,074 mil lion in 2007. The 

USA rep re sented 31% of to tal sales in 2008, down from 34% in 2007. Af ter the USA, the com pany’s larg - 

est sin gle mar ket in 2008 was Ger many (10% of sales) with sales of $4,114 mil lion, up 7.1% based on 

con tin u ing op er a tions of $3,840 mil lion, fol lowed by Ja pan (7% of sales) with sales of $2,987 mil lion, up 

16.7% from $2,559 mil lion. France, which rep re sented 6% of sales in 2008, had sales of $2,284 million, 

up 9.8% on 2007. 

In Pharmaceuticals sales in the USA fell 1.5% in 2008 to $8,616 mil lion from $8,748 mil lion in 2007, 

whereas in the rest of the world sales rose 16% to $17,715 mil lion from $15,277 mil lion in 2007. Ac cord - 

ing to Novartis in lo cal cur rency terms sales grew 10% in Eu rope ($10.1 bil lion), 8% in Latin Amer ica 

($1.7 bil lion), 4% in Ja pan ($2.6 bil lion), and the rest of the world ($2.6 bil lion) was up 15%. The emerg - 

ing mar kets of China, Rus sia, South Ko rea and Tur key de liv ered more than 20% growth in lo cal cur rency 

terms, noted Novartis. 

One ex cep tion to the poor per for mance in the USA was in Vac cines and Di ag nos tics with sales up 27% to 

$765 mil lion from $602 mil lion in 2007. In the rest of the world sales rose 16.9% (12% in lo cal cur rency 

terms) to $994 mil lion from $850 million. 

For Sandoz sales fell 9.9% in 2008 in the USA to $1,766 mil lion, but rose 11.2% (5% in lo cal cur rency 

terms) in the rest of the world to $5,791 mil lion. 

Sales in Con sumer Health fell 2.9% in the USA in 2008 to $1,714 mil lion, but rose 11.9% (7% in lo cal cur - 

rency terms) in the rest of the world to $4,098 mil lion. 

$ millions 

16,000 

14,000 

12,000 

10,000 

8,000 

6,000 

4,000 

2,000 

0 

Sales by Geographic Region 

2004 2005 2006 2007 2008 


Switzerland USA Germany Japan France UK Austria 



An a lyst Com ment 

Fol low ing the re lease of Q4 re sults, Cowen & Co an a lysts (Jan u ary 2009) noted that the re sults were “dis - 

ap point ing” but that the “out look re mains ro bust” They high lighted that Novartis re ported sig nif i cantly 

lower-than-ex pected EPS and lack lus ter rev e nues. They noted that the Phar ma ceu ti cal and Vac cines 

busi nesses dem on strated good mo men tum, in Q4, but that Sandoz and Con sumer “con tinue to face 

head winds.” The con cluded that they “con tinue to be lieve that NVS should de liver top-tier growth 

through 2015.” The analysts rated Novartis “Outperform.” 

Mor gan Stan ley an a lysts (Jan u ary 2009) once again rated Novartis “Over weight” and noted that Q4 rev - 

e nues were 2% be low their ex pec ta tions and 4% be low the con sen sus. They put this down to cur rency 

ef fects and the nu mer ous “one-time” items which in creased op er at ing ex penses. Con sumer Healthcare 

how ever, was con sid er ably lower than they had an tic i pated, and the an a lysts sug gest that this shows 

that the busi ness is more cy cli cal than they had previously anticipated. 

In June 2008, Mor gan Stan ley an a lysts re it er ated their ‘Over weight’ rat ing on Novartis fol low ing its vac - 

cines day, which they said, “in di cates fore casts are set to dou ble. The Novartis vac cines day con firmed 

that the phar ma ceu ti cal in dus try is on the cusp of con sid er able tech no log i cal break through, with three 

new po ten tial vac cines set to be launched ahead of 2010/11. As we high lighted in April 2008, we con tinue 

to be lieve that the meningococcal vac cine mar ket is set to grow from circa $1 bil lion cur rently to circa $5 

bil lion by 2015 (e), with Novartis set to be the dom i nant player. With up side to both rev e nues and mar gin 

es ti mates, con sen sus vac cines fore casts may need to dou ble un der our blue sky sce nario, thereby adding 

circa 5-15% to longer term EPS forecasts.” 

The an a lysts state that they like “Novartis’ di ver si fied healthcare busi ness model, with pharmaceuticals, 

vac cines, generics and con sumer health. In 2013, we es ti mate that only 45% of Novartis’ rev e nue will 

come from small mol e cule pharmaceuticals.” They also added that they con sider that in ves tors have 

failed to ap pre ci ate the sig nif i cance of Novartis’ vac cines port fo lio; they think this could add more than 

15% to con sen sus EPS fore casts. And they think that al though the Alcon trans ac tion came at a high price, 

Novartis will now have a smooth earn ings pro gres sion from 2010 to 2015, un like many of its peers. They 

see key value driv ers as Glivec and Tasigna in on col ogy/CML, Tekturna (which should have rev e nues of 

$830 mil lion in 2014, when Diovan faces ge neric com pe ti tion), non-pharma as sets, such as vac cines, 

generics and con sumer health) and, in par tic u lar, the vac cines busi ness (which should have rev e nues of 

$4 bil lion in 2013, com pared to $1.5 billion in 2007, driven by Menveo and MenB). 

In re ports through 2008, Mor gan Stan ley an a lysts have noted the loss in sales fol low ing 2007’s launch of 

ge neric ver sions of Lotrel, Trileptal, Lamisil and Famvir, and the with drawal of Zelnorm. They es ti mate 

that Novartis has lost around $3.2 bil lion in branded phar ma ceu ti cal rev e nues and 10% of its 2006 group 

rev e nues. They es ti mate this ac counts to $2.8 bil lion of gross profit. How ever, they high lighted that in 

2011, Novartis will en ter one of the tough est pe ri ods for any of the pharma ma jors. Be tween 2011-2015, 

they ex pect ge neric com pe ti tion to emerge for prod ucts that will gen er ate rev e nues of $15.6 bil lion in 

2010, rep re sent ing 55% of 2010 phar ma ceu ti cal rev e nues and 35% of 2010 group rev e nues. Ap prox i - 

mately 40% of the rev e nues ex posed to pat ent ex pi ra tions are within the US, where ge neric en trants 

typ i cally capture 80-90% market share during the first three months. 



Prod ucts Fac ing Pat ent Ex piry 

Product Sales 2008 Expiry 

USA 

Certican 

(everolimus) 

Comtan 

(entacapone) 

Diovan 

(valsartan)* 

Elidel 

(pimecrolimus) 

Enablex/ 

Emselex 

(darifenacin)** 

Exelon 

(rivastigmine) 

Famvir 

(famciclovir) 

Femara 

(letrozole) 

Product Portfolio 

Expiry Japan Expiry Europe Analyst Sales 

Forecast 2012 

N/A Sep 2014 Sep 2013 Patents to Sep 2013, 

SPCs to Jul 2018 

$502m 

(combined 

sales of 

Comtan and 

Stalevo) 

$5,740m 

(inc. 

Co-Diovan) 

Oct 2013 Nov 2007 

(extended) (extension 

applied for) 

Mar 2012 Sep 2013 

(extended) 

Patents to Nov 2007, 

mainly SPCs to 

Nov2012 (Portugal 

Mar 2013) 

Patents Feb 2011 but 

mainly SPCs to May 

2011 (Switzerland 

Aug 2011) 

$157m (E) Dec 2016 Nov 2010 Patents to Nov 2010, 

(extended) 

SPCs to Nov 2015 

$210m (E) Mar 2015 Mar 2010 Patents to Mar 2010, 

(extended) 

SPCs to Mar 2015 or 

filed for 

$815m Feb 2014 Mar 2008 Patents Mar 2008 but 

mostly SPCs to Aug 

2012 (Portugal to Apr 

2013) 

$236m 

(2007 sales) 

N/A 

$640m 

$3,933-4,141m 

$124m 

$267-313m 

$749-900m 

Sep 2010 Sep 2005 Mainly SPCs to Dec 

2008 (Sweden Sep 

2009; Switzerland Sep 

2010) 

$86m 

$1,129m June 2011 Mar 2012 

(extended) (extended) 

Patents Mar 2007 but 

mainly SPCs to Jul 

2011 (Switzerland Feb 

2012) 

© 2009 IMS Health In cor po rated or its af fil i ates Page 21 

$774-898m


Product Sales 2008 Expiry 

USA 

Lescol 

(fluvastatin) 

Myfortic 

(mycophenolate 

sodium) 

Simulect 

(basiliximab) 

Starlix 

(nateglinide) 

Vectavir/Denavir 

(penciclovir) 

Visudyne 

(verteporfin) 

Xolair 

(omalizumab) 

Zelmac/Zelnorm 

(tegaserod) 

Zometa 

(zoledronic acid) 

$645m Oct 2011 Nov 2008 

(extended) 

N/A May 2009 Dec 2012 


N/A Feb 2020 Jul 2013 

(extended) 

N/A Sep 2009 Mar 2011 


Expiry Japan Expiry Europe Analyst Sales 

Forecast 2012 

Mainly SPCs to Aug 

2008 (Switzerland, 

Liechtenstein, 

Luxembourg Nov 

2008; Portugal Apr 

2009) 

Patents to Dec 2007, 

SPCs to Nov 2010 

Patents to Mar 2011, 

SPCs to Apr 2013, 

Portugal May 2015 

(SPC rejected in UK) 

Patents to Mar 2006, 

SPCs in France, 

Germany Switzerland 

UK to Mar 2011 

N/A Sep 2010 Aug 2004 Mainly SPCs to Aug 

(extended) 

2009 

$179m 

(2007 sales) 

$140m 

(2007 sales) 

$88m (2007 

sales) 

Source: IMS Pat ent Fo cus 

Sep 2011 Jul 2014 


Patents Jul 2009 but 

mainly SPCs to Jul 

2014 

Jun 2017 Aug 2012 Patents to Aug 2012, 

(extended) 

SPCs to Aug 2017 

$382-477m 

$500m 

N/A 

N/A 

N/A 

$82m 

$256-275m 

Jul 2016 Mar 2012 Mar 2012 (Switzerland $13m 

(extended) 

SPC to Oct 2016) 

$1,382m Mar 2013 Nov 2012 


Patents Nov 2007 but 

mainly SPCs to Nov 

2012 

$2,063-2,111m 

*Note: Pat ents on com po si tions of valsartan with amlodipine ex pire around 2019; pat ents on com po si - 

tions with hy dro chlo ro thi a zide ex pire around 2017 

**Note: Also some SPCs on com po si tion pat ents; pat ents ex pire in 2016, with SPCs to 2019-2020 



Sales of Novartis’ core Pharmaceuticals busi ness grew by 10% (5% in lo cal cur rency) in 2008 to $26.3 

bil lion, driven mainly by the on col ogy fran chise and steady growth of the car dio vas cu lar port fo lio: the 

fig ure in cludes $2.9 bil lion from re cently launched prod ucts. There was strong growth in Eu rope, Latin 

Amer ica and key emerg ing mar kets, but in the USA net sales fell 2% to $8.6 bil lion due to ge neric com pe - 

ti tion. Five prod ucts achieved over $1 bil lion in sales in 2008: Diovan (valsartan) with sales of $5,740 mil - 

lion, up 15%, Gleevec/Glivec (imatinib) with sales of $3,670 mil lion up 20%, Zometa (zoledronic acid) 

with sales of $1,382 mil lion, up 7%, Femara (letrozole) with sales of $1,129 mil lion, up 20%, and 

Sandostatin (octreotide) with sales of $1,123 million, up 9%. 

Re cently-launched prod ucts that have per formed well in 2008 in clude Lucentis (ranibizumab) for the 

treat ment of age-re lated macular de gen er a tion with sales up 125% to $886 mil lion, Exforge (valsartan + 

amlodipine) for hy per ten sion with sales up 294% to $406 mil lion, and Exjade (deferasirox) for iron over - 

load with sales up 49% to $531 mil lion. The launch of the Exelon Patch (rivastigmine) for the treat ment of 

Alz hei mer’s dis ease has re vived the flag ging Exelon fran chise, with to tal sales of the fran chise up 29% in 

2008 to $815 mil lion. Other new mar ket en trants are Tekturna/Rasilez (aliskiren) for hy per ten sion, 

Aclasta/Reclast (zoledronic acid) for os teo po ro sis, and Tasigna (nilotinib) for cancer. 

Novartis was hit by pat ent ex pi ries and ge neric com pe ti tion in 2007 and this ef fect was still be ing felt in 

2008, in clud ing Lotrel sales down 48% and Trileptal sales down 52%. 

Novartis’ lead ing drug Diovan is mar keted world wide for the treat ment of hy per ten sion and has now also 

been ap proved in more than 50 mar kets for use in pa tients with heart fail ure and at those at high-risk af - 

ter sur viv ing a heart at tack. Com bined sales of Diovan/Co-Diovan (valsartan + HCTZ) came to $5.7 bil - 

lion in 2008, up 15%. In Jan u ary 2009, Co-Diovan was ap proved in Ja pan, where it will be sold as Co-Dio. 

Diovan’s pat ent ex clu siv ity in the USA ex tends to Sep tem ber 2012 and pat ents be gin to ex pire in Eu rope 

in 2011, and ac cord ing to Mor gan Stan ley an a lysts (Jan u ary 2009), sales could peak at $5.8 bil lion in 

2010. Novartis’ com bi na tion prod uct Exforge (valsartan + amlodipine) is be ing rolled out world wide, in - 

clud ing in July 2008 in the USA. This prod uct will not pro tect the com pany from the loss of sales of Diovan 

fol low ing pat ent ex piry, how ever: Mor gan Stan ley an a lysts (Jan u ary 2009) predict peak sales of $874 

million in 2011-12. 

In sec ond po si tion, Gleevec/Glivec, a ty ro sine kinase in hib i tor, is a ma jor driver for Novartis’ on col ogy 

fran chise with sales up 20% in 2008. It was first ap proved in 2001 for use in the treat ment of CML. It is 

now mar keted in over 80 coun tries for CML and in the treat ment of gas tro in tes ti nal stromal tu mors 

(GIST) and other rare dis eases. In De cem ber 2008 Gleevec was ap proved by the US FDA for adjuvant 

treat ment of GIST fol low ing sur gery for tu mor re moval. Novartis has filed for ap proval in use in this in di - 

ca tion in the EU, Swit zer land and other mar kets with launches expected in 2009. 

Novartis’ num ber three prod uct, Zometa, a bisphosphonate for pa tients with bone can cer ex pe ri enced 

growth of 7% in 2008, ac cord ing to Novartis, due to im proved com pli ance, but in the lat ter half of the 

year due to good clin i cal trial re sults of its use in breast can cer that could ex pand its use con sid er ably. 

Zometa in com bi na tion with hor mone ther apy was found to sig nif i cantly re duce the risk of re cur rence or 

death in pre-meno pausal women with hor mone-sen si tive early stage breast can cer com pared to hor - 

mone ther apy alone. Phase III tri als in this set ting are on go ing with a first fil ing pro jected for 2010, but 

Mor gan Stan ley an a lysts (De cem ber 2008) re port that it is al ready in creas ingly be ing used in this set ting 

by clin i cal oncologists in the USA and in Europe, where funding allows. 

Femara, an oral, non-steroidal aromatase in hib i tor, was first launched in the UK in 1996. It is now avail - 

able in more than 90 coun tries for ad vanced breast can cer in post-meno pausal women. Since its first 

launch the prod uct’s in di ca tion has steadily been broad ened based on ex cel lent trial re sults. It is also ap - 

proved for use in the early adjuvant treat ment of breast can cer in the US and in the EU. It was Novartis’ 

num ber four prod uct in 2008, with sales up 20%. Femara could face ge neric com pe ti tion in 2011. Mylan 

has filed an ANDA for a ge neric ver sion and has re ceived ten ta tive ap proval, but in De cem ber 2008 Mylan 



re ported that it had come to a set tle ment agree ment with Novartis that will allow it to market 2.5mg 

tablets. 

Fifth placed Sandostatin, for the treat ment of acromegaly, has ex pe ri enced growth due to in creased use 

of the once-monthly ver sion, Sandostatin LAR, which now ac counts for 85% of sales. Novartis re ports 

that in 2008 new com pe ti tion to the Sandostatin LAR prod uct has had min i mal im pact on prod uct sales. 

Pharmaceuticals 

Alimentary Tract and Metabolism Agents 

EUCREAS (vildagliptin + metformin) is a fixed com bi na tion oral tab let for mu la tion of vildagliptin, a 

dipeptidyl peptidase IV in hib i tor, com bined with metformin for the treat ment of Type 2 di a be tes. It was 

first launched in the UK in March 2008. It has since been launched in Fin land, Den mark, Brazil, Nor way, 

Ger many, Spain, Aus tria and Hungary. 

GALVUS (vildagliptin), an oral dipeptidyl peptidase IV (DPP-IV) in hib i tor, was first launched in June 2007 

in Brazil and Mex ico. In Sep tem ber 2007, it was ap proved in all 27 EU mem ber states plus Nor way and 

Ice land for the treat ment of Type 2 di a be tes. The ap proval al lows for once-daily oral vildagliptin to be ad - 

min is tered with other oral antidiabetic med i ca tions, in clud ing metformin, sulfonylureas (SUs) or 

thiazolidinediones. How ever, Novartis has found liver safety prob lems with high doses of the drug and 

sought re vi sion of pre scrib ing rec om men da tions be fore in tro duc ing Galvus to the Eu ro pean mar ket. In 

Feb ru ary 2008, Novartis re ported that the Eu ro pean Com mis sion had ap proved the pre scrib ing changes 

for vildagliptin in all 27 EU coun tries, as well as Nor way and Ice land; the ap proval cov ers the use of 50 mg 

once-daily vildagliptin in com bi na tion with a sulphonylurea, or 50 mg twice-daily vildagliptin in com bi na - 

tion with metformin or a thiazolidinedione. The pre vi ously ap proved 100 mg once daily dose of 

vildagliptin will not be avail able. In 2008, Galvus was launched in Sin ga pore, the UK, Nor way, It aly, Fin - 

land and the Czech Republic. It was filed for approval in Japan in April 2008. 

EU ap proval was granted in No vem ber 2007 for Eucreas, a sin gle-tab let com bi na tion of Galvus with the 

oral antidiabetic med i cine metformin, and it was launched in Eu rope in 2008. 

Skin tox ic ity wor ries have set back Galvus’ ap proval in the US. Filed with the FDA in early 2006, Galvus 

first had its re view pe riod ex tended by the FDA by three months from No vem ber 2006 af ter clin i cal data 

were sub mit ted to sup port the pro posed dos ing and in di ca tions as well as com ple ment ear lier data on the 

risk/ben e fit pro file. Then in Feb ru ary 2007 the FDA is sued an ap prov able let ter for the prod uct and re - 

quested ad di tional data, in clud ing a clin i cal study in pa tients with re nal im pair ment. This has de layed the 

de vel op ment of Galvus in the US in at least two years. Novartis is now con duct ing safety stud ies but a 

resubmission for US regulatory approval is not expected before 2010. 

Li cens ing: In March 2008, Novartis Ko rea and HANDOK (South Ko rea) signed a co-pro mo tion agree - 

ment for vildagliptin in South Ko rea. 

Clin i cal Data: In Sep tem ber 2008, Novartis re ported re sults from the GALIANT trial of more than 2,400 

pa tients with Type 2 di a be tes treated with vildagliptin 100 mg once-daily. Vildagliptin showed non-in fe - 

rior ef fi cacy to thiazolidinediones (TZDs) (-0.68% ver sus -0.57% HbA1c re spec tively, p = 0.001) in pa - 

tients with in ad e quately con trolled blood sugar lev els (HbA1c more than 7%) with metformin alone. 

Weight loss was noted in pa tients treated with vildagliptin whereas those pa tients treated with TZDs put 

on weight (-0.58 kg ver sus +0.33 kg, re spec tively). From a pooled anal y sis from ap prox i mately 6,000 

pa tients, vildagliptin was shown to have a fa vor able car dio vas cu lar pro file, with fewer car dio vas cu lar and 

cerebrovascular events e.g. heart at tacks and strokes, than pla cebo. An anal y sis of pooled re sults from 



more than 1,400 pa tients showed that vildagliptin is well tol er ated in pa tients with type II di a be tes with 

mild-to-mod er ate re nal im pair ment. Pa tients with mild re nal im pair ment and pa tients with normal renal 

function reported similar efficacy of vildagliptin. 

Com pe ti tion: Novartis lost the race to be come first on the mar ket with a DDP-IV in hib i tor. Merck & Co’s 

Januvia (sitagliptin) was launched in the USA in Oc to ber 2006. Merck filed Januvia in Feb ru ary 2006, 

just ahead of Galvus fil ing in March. Januvia does not cause weight gain, an ad van tage over some older 

di a be tes treat ments. In March 2007 it was also ap proved in the EU. Januvia has been ex tremely suc cess - 

ful and is now a lead ing oral antidiabetic. 

There are sev eral other DPP-IV in hib i tors close to mar ket. Takeda’s alogliptin was sub mit ted for ap - 

proval with the US FDA in Jan u ary 2008 and in Ja pan in Sep tem ber 2008. In Oc to ber 2008, it was re - 

ported that Takeda had re ceived no ti fi ca tion that the FDA will not be able to com plete its re view of the 

alogliptin NDA by the PDUFA date of Oc to ber 27 2008, due to “in ter nal re source con straints”. In Jan u ary 

2009 Takeda stated that the re view would be com plete in June 2009. Bris tol Myers-Squibb’s Onglyza 

(saxagliptin) was sub mit ted for ap proval in the USA and Eu rope in July 2008. Slightly fur ther back in de - 

vel op ment is Phenomix/For est (both USA)’s dutogliptin in phase III tri als and Boehringer Ingelheim’s 

BI 1356 which be gan phase III tri als in Au gust 2008. There are sev eral DPP-IV in hib i tors in phase II tri - 

als, in clud ing Mitsubishi Tanabe Pharma’s TA 6666 (li censed to GlaxoSmithKline), Glenmark’s (In dia) 

melogliptin, Roche’s carmegliptin, and ActivX (USA)/Kyorin (Ja pan)’s KRP 104. 

In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Januvia was the world’s num ber 

two prod uct in the A10B class (Oral Antidiabetics), with an 8.7% mar ket share and 178% fixed rate dol lar 

growth. A com bi na tion of sitagliptin and metformin, Janumet, was the num ber 12 prod uct in the class 

dur ing the same pe riod, with a 1.9% mar ket share and 599% growth. The lead ing prod uct in this class 

was Takeda’s Actos (pioglitazone), with a 28.1% mar ket share and 9% fixed rate dol lar growth. Num ber 

three was GSK’s Avandia (rosiglitazone), with a 8.1% mar ket share, but sales down 52% in fixed rate 

dol lar terms. Sales of Avandia have been ad versely af fected by the pub li ca tion of a study in 2007 link ing it 

to car dio vas cu lar prob lems. Galvus did not fig ure among the top 15 prod ucts in the class during this 

period. 

Sales/An a lyst Com ment: Novartis and an a lysts had high lighted Galvus as a po ten tial $1 bil lion plus 

prod uct. How ever, in No vem ber 2007, fol low ing the an nounce ment of new liver safety prob lems with 

high doses of the drug, Mor gan Stan ley an a lysts cut their Galvus sales fore cast. In Jan u ary 2009, they 

fore cast Galvus sales of $80 mil lion in 2009 ($473 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) 

put 2007 sales at $8 mil lion. They fore cast sales of $35 mil lion in 2008 ($120 million by 2013). 

NAVOBAN/NOVOBAN (tropisetron), a 5HT-3 an tag o nist anti-emetic/antinauseant, launched in Eu - 

rope in 1992, and now avail able in around 50 mar kets world wide. It was launched in Ja pan in 1998. Clin i - 

cal tri als were car ried out in the USA, but it has not been launched there. 

STARLIX (nateglinide), an in su lin secretagogue, was launched in its first mar ket, Ja pan, in 1999 by 

Yamanouchi (now Astellas, Ja pan) as Starsis, and Aventis (now sanofi-aventis, France) as Fastic. It is 

in di cated for non-in su lin de pend ent di a be tes mellitus (Type 2 di a be tes) as a monotherapy or in com bi na - 

tion with other oral antidiabetics such as Merck KGaA’s Glucophage (metformin) in pa tients whose 

blood glu cose level is not con trolled by diet and ex er cise alone. Ad di tional FDA ap proval in com bi na tion 

with a thiazolidinedione was given in 2003 in pa tients who are not ad e quately con trolled af ter a ther a peu - 

tic re sponse to a TZD. Novartis has launched Starlix across Eu rope, as well as in South Af rica, the United 

Arab Emirates, Latin Amer ica, the USA (2001) and Can ada (2002). Nateglinide is an amino acid de riv a - 

tive. It stim u lates early in su lin se cre tion, with a rapid on set and short du ra tion of ac tion. It has a faster 

onset of action than other oral antidiabetic drugs. 



Li cens ing: Nateglinide was li censed-in from Aji no mo to (Ja pan) in 1994 by Novartis for mar ket ing world - 

wide out side Ja pan, South Ko rea, Tai wan, China, the UK, and Ire land. In 2000, Merck KGaA ac quired 

co-pro mo tion and co-mar ket ing rights from Novartis. Merck is com mer cial iz ing Starlix in Eu rope and cer - 

tain coun tries in Af rica, South east Asia, and Latin Amer ica for the com plete term of nateglinide’s pat ent. 

Sankyo (Ja pan) ob tained lo cal co-li censed mar ket ing rights in Ja pan in 2002 and took over co-mar ket ing 

in Japan from sanofi-aventis. 

Clin i cal Data: Novartis an nounced plans to con duct the larg est clin i cal trial to date on the pre ven tion of 

Type 2 di a be tes and car dio vas cu lar dis ease in 2001. The NAV I GA TOR (Nateglinide And Valsartan in Im - 

paired Glu cose Tol er ance Out comes Re search) trial will in ves ti gate whether Starlix or high blood pres sure 

med i ca tion Diovan (valsartan) can pre vent di a be tes and/or car dio vas cu lar events in in di vid u als with im - 

paired glu cose tol er ance that are at high risk for car dio vas cu lar events. NAV I GA TOR is a mul ti na tional 

study that will involve about 7,500 individual in over 30 countries. 

ZELMAC/ZELNORM (tegaserod), an aminoguanidine indole 5HT4 ag o nist for ir ri ta ble bowel syn drome 

(IBS) was launched in Mex ico, its first world mar ket in 2001. It has since been launched in over 56 coun - 

tries as a short-term treat ment for women with IBS with con sti pa tion as the pri mary symp tom. It is also 

ap proved for use in chronic con sti pa tion in more than 20 mar kets. It was ap proved and launched in the 

USA in 2002, as a short-term treat ment for women with con sti pa tion as the primary symptom of IBS. 

In March 2007, the FDA re quested that Novartis sus pend sales and mar ket ing of Zelnorm in the USA. This 

move was in re sponse to a ret ro spec tive anal y sis of clin i cal trial data from over 18,000 pa tients, show ing 

a sta tis ti cally sig nif i cant im bal ance in the in ci dence of car dio vas cu lar ischemic events, in clud ing myo car - 

dial in farc tion, stroke and un sta ble an gina pectoris, in pa tients tak ing tegaserod (in ci dence of 0.11%) 

com pared to pla cebo (in ci dence of 0.01%). Sub se quently, Can ada (April 2007), Aus tra lia (April 2007), 

Swit zer land (May 2007) and a num ber of other coun tries also requested the withdrawal of tegaserod. 

In July 2007, Novartis an nounced that it has es tab lished with the FDA, a re stricted ac cess pro gram 

(called a treat ment IND) for Zelnorm so that pa tients who need tegaserod can be con sid ered for treat - 

ment. The pro gram al lows women in the USA un der 55 years of age who suf fer from IBS with con sti pa - 

tion (IBS-C) or chronic id io pathic con sti pa tion (CIC) and for whom no other treat ment has pro vided 

sat is fac tory re lief and/or pa tients who had sat is fac tory im prove ment of their symp toms with prior 

tegaserod treat ment for IBS-C or CIC to have ac cess to tegaserod for re lief of the symp toms as so ci ated 

with these con di tions. The pro gram pro to col en sures that pa tients and phy si cians are fully in formed of 

the potential risks and benefits of the drug. 

Even be fore the most re cent prob lems in the USA, Zelnorm had not had an easy time from the reg u la tory 

au thor i ties. In Eu rope, Novartis with drew its ap pli ca tion in 2001 be cause of a dis pute over ef fec tive ness 

with the Eu ro pean au thor i ties, but in 2004 it re-filed tegaserod, based on data from the ZENSAA trial. The 

agency is sued a neg a tive opin ion in 2005. Novartis ap pealed and again the agency rec om mended 

against the ap proval of tegaserod. In the USA, the FDA ini tially re jected tegaserod in 2001 on safety 

grounds, par tic u larly the in ci dence of gall blad der re mov als in treated pa tients, but later re versed its de ci - 

sion. Novartis says the in ci dence of gall blad der re mov als is con sis tent with that of the gen eral IBS pop u - 

la tion (2-3 times higher than the general population). 

In 2004, the FDA added a warn ing against se ri ous con se quences of di ar rhea as so ci ated with use of 

Zelnorm, as well as pre cau tions about ischemic co li tis (re duced blood flow to the in tes tines, the same ad - 

verse event that led to with drawal of GSK’s Lotronex in 2000). Novartis’ re sponse was that these side 

ef fects are rare, how ever crit ics claim that the drug does not of fer enough im prove ment over pla cebo to 

war rant the potential dangers. 

Pat ents: Ac cord ing to IMS Pat ents In ter na tional, pat ents on Zelmac run un til 2012 in many mar kets (the 

pat ent has been ex tended to 2016 in the USA). 



Com pe ti tion: Ac cord ing to IMS, Zelmac was the sec ond lead ing gas tro in tes ti nal sensorimotor mod u la - 

tor in the 12-month pe riod to the end of Sep tem ber 2008, with sales down 94% in fixed rate dol lar terms. 

It made up 45.2% of the mar ket or $19 mil lion in sales. Its only ma jor com pet i tor in this class is 

GlaxoSmithKline’s Lotronex (alosetron) which led the mar ket with a 51.7% mar ket share or $22 mil lion 

in sales, up 43% in fixed rate dol lar terms. Also in cluded in the class are some ge neric ver sions of 

tegaserod sold in In dia, Ban gla desh, Pa ki stan, Chile, Peru and Co lom bia, which have neg li gi ble sales. 

Lotronex tar gets di ar rhea-pre dom i nant IBS (and is a 5HT3 an tag o nist), while Zelmac tar gets con sti pa - 

tion-pre dom i nant IBS (and is a 5HT4 ag o nist). In 2007, Pro me theus Lab o ra to ries (USA) gained exclusive 

rights to Lotronex in the USA. 

A re cent new com pet i tor in this area is Takeda’s Amitza (lubiprostone) a se lec tive chlo ride chan nel ac ti - 

va tor that works to in crease fluid se cre tion and mo til ity in the in tes tine speed ing up the pas sage of stool 

and thus re duc ing symp toms of con sti pa tion. Amitza was ap proved by the US FDA in April 2008 in adults 

(fe male) for con sti pa tion-pre dom i nant ir ri ta ble bowel syn drome (IBS-C) fol low ing the fil ing of a sNDA in 

July 2007. Amitza is pend ing ap proval in Eu rope. Also pend ing ap proval in Eu rope is Movetis’ 

prucalopride, a se lec tive 5-HT4 re cep tor ag o nist, for the treat ment of gas tro in tes ti nal mo til ity dis or - 

ders, es pe cially those af fect ing the lower bowel, in clud ing chronic con sti pa tion and irritable bowel 

syndrome (IBS). It was filed for approval in May 2008. 

Sales/An a lyst Com ment: Zelnorm/Zelmac fell from the list of top 20 Novartis prod ucts in 2007 fol low - 

ing sus pen sion in the US and other mar kets. Ther a peu tic op tions for IBS are lim ited. Med i ca tions in the 

past have usu ally been di rected at iso lated symp toms (e.g. di ar rhea/con sti pa tion). With the mar ket sus - 

pen sion in the US and other mar kets in 2007, the pros pects for Zelnorm look gloomy al though the FDA 

left the door opened for the pos si bil ity of the drug re turn ing to the US mar ket. In dus try an a lysts say that 

even if the prod uct is re in tro duced, its sales will prob a bly be low be cause of the neg a tive pub lic ity and the 

pos si bil ity of in creased risk for car dio vas cu lar events. Mor gan Stan ley an a lysts (Jan u ary 2009) have con - 

sid er ably re duced fore casts for Zelnorm. They now ex pect only $13 mil lion in sales be tween 2009-2014. 

Cowen & Co an a lysts (Au gust 2008) put 2007 sales at $88 mil lion and think sales will fall to $15 million in 

2008 ($10 million by 2012/2013). 

Antineoplastics/Immunomodulating Agents 

CERTICAN (everolimus), an orally ac tive rapamycin an a logue with immunosuppressant ac tiv ity, was 

ap proved for the pre ven tion of re jec tion in re nal and heart trans plan ta tion in Swe den in 2003. Swe den 

acted as the ref er ence mem ber state for the EU’s Mu tual Rec og ni tion pro cess, which com pleted by the 

end of 2003 in 15 coun tries. In 2004, Novartis launched everolimus in Ger many, its first world mar ket, for 

the pre ven tion of re jec tion ep i sodes in pa tients with heart and kid ney trans plants in com bi na tion with low 

dose ciclosporin. It has now been launched in sev eral world mar kets, most re cently in Rus sia in 2008. In 

2007, Novartis re ported that phase III tri als in liver trans plan ta tion were also un der way. Everolimus is 

now be ing de vel oped for the treat ment of cancer by Novartis under the brandname Afinitor. 

Li cens ing: In 2002, Novartis li censed everolimus to Guidant (USA) on a co-ex clu sive ba sis for use in the 

lat ter’s drug-eluting stents for the treat ment of cor o nary and pe riph eral vas cu lar dis eases. Novartis will 

pro vide everolimus to Guidant, sup ply data to sup port reg u la tory fil ings, and re ceive mile stone pay ments 

and roy al ties on sales of everolimus-eluting stents. This agree ment was later re vised to give Guidant ex - 

clu siv ity, and the right to grant sub-licenses. 

Pat ents: Wyeth had be gun le gal pro ceed ings against Novartis in cer tain EU coun tries, claim ing that 

everolimus in fringes sirolimus pat ents. How ever, Novartis has been granted a dec la ra tion of non-in - 

fringe ment in a num ber of coun tries. Both Wyeth and Novartis EU pat ents are due to ex pire around 2010. 

In 2001, the Eu ro pean Pat ent Of fice up held Novartis’ European patent. 



Lifecycle Man age ment: Everolimus is be ing de vel oped for on col ogy in di ca tions, with the labcode RAD 

001 and the brand name Afinitor, and it is pend ing ap proval in the USA, the EU and Swit zer land for met - 

a static re nal cell car ci noma fol low ing reg u la tory sub mis sions in 2008. Novartis an tic i pates an ap proval in 

2009 and more reg u la tory fil ings. A phase III pro gram has been com pleted in met a static re nal cell can cer 

(mRCC), and phase II tri als on go ing in mul ti ple can cer types, in clud ing neuroendocrine tu mors, lym - 

phoma, hepatocarcinoma, gas tric can cer, nonsmall cell lung can cer and breast can cer. In Sep tem ber 

2008, Afinitor (everolimus) was granted Pri or ity Re view sta tus by the US FDA for the treat ment of pa - 

tients with ad vanced mRCC af ter fail ure of stan dard treat ment. How ever, in No vem ber 2008 Novartis 

reported that the FDA had requested additional information. 

In No vem ber 2008, Novartis stated, “Afinitor, an oral in hib i tor of the mTOR path way, is ex pected to re - 

ceive a reg u la tory de ci sion from the FDA within the Q1 2009 for pa tients with ad vanced kid ney can cer. 

The FDA has re quested some data clar i fi ca tion and re for mat ting re lated to pre vi ously sub mit ted on col ogy 

stud ies as well as ad di tional data from the on go ing trial in pan cre atic neuroendocrine tu mors (pNET). As a 

re sult, the ac tion date has been ex tended by three months, but the FDA has not asked for ad di tional stud - 

ies. Afinitor was ac cepted for pri or ity re view in mid-2008 based on re sults of the RE CORD-1 tri als that 

showed it more than dou bled the time with out tu mor growth in pa tients with ad vanced kid ney can cer af - 

ter fail ure of stan dard treat ment. Clinical trials are continuing as planned in other cancers.” 

Clin i cal Data: In May 2008 at ASCO, Novartis re ported that everolimus for the treat ment of can cer 

(Afinitor) more than dou bled the time with out tu mor growth in pa tients with ad vanced kid ney can cer af - 

ter fail ure of stan dard treat ment. The phase III re sults from the RE CORD-1 trial, which was stopped early 

based on these re sults pre sented at ASCO, will form the ba sis for global reg u la tory sub mis sions in 2008 

for ap proval in treat ing pa tients with ad vanced met a static re nal cell can cer. The com pany re ported that 

reg is tra tion tri als in other can cers are un der way. Early proof-of-con cept stud ies pre sented at ASCO 

showed Afinitor may of fer a novel treat ment strat egy for breast can cer by over com ing re sis tance and en - 

hanc ing the ef fi cacy of sev eral com monly used breast can cer treat ments. Novartis stated that a new trial 

to ex plore the po ten tial of Afinitor in breast can cer will be ini ti ated in early 2009. Afinitor acts by di rectly 

in hib it ing tu mor cell growth and me tab o lism as well as the formation of new blood vessels 

(angiogenesis). 

Com pe ti tion: Certican re port edly has ad van tages over its com pet i tors, most no ta bly Wyeth’s 

Rapamune (sirolimus), in that it is given in a solid, oral-dose form, has a shorter half-life and can be 

dosed at the same time as Novartis’ Neoral/Sandimmun. There is also some ev i dence that Certican 

has a neuroprotective (and pos si bly nephroprotective) ef fect not seen with other immunosuppressants. 

In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Certican (everolimus) was the 

num ber 12 prod uct world wide in the class, with a 0.6% mar ket share and 48% fixed rate dol lar growth. 

Num ber one was J&J’s Remicade (infliximab), with a 40.7% mar ket share and sales up 16% in fixed rate 

dol lar terms. It is in di cated in var i ous au to im mune con di tions, but is not a di rect com pet i tor to Certican in 

the trans plan ta tion field. Num ber two was Astellas’ Prograf (tacrolimus), with a 15.9% mar ket share 

and 14% fixed rate dol lar growth. Num ber three was Roche’s CellCept (mycophenolate mofetil), with a 

14.9% mar ket share and 12% dol lar growth. Novartis’ Sandimmun was the num ber four prod uct 

world wide in the immunosuppressive agents class (L4A), with a 7.7% mar ket share but sales down 3% in 

fixed rate dol lar terms. Num ber five was Celgene’s Revlimid (lenalidomide), with a 4.5% mar ket share 

and 240% fixed rate dol lar growth: this is also not a di rect com pet i tor to Certican as it is in di cated for 

myelodysplastic syn drome. Num ber six was Biogen Idec’s Tysabri (natalizumab), which is used in MS, 

with a 3.9% mar ket share and 249% fixed rate dol lar growth. Num ber seven was Wyeth’s Rapamune 

(sirolimus), with a 2.5% mar ket share and 1% dol lar growth. Num ber eight was Novartis’ Myfortic 

(mycophenolic acid), with a 1.6% market share and 38% fixed rate dollar growth. 

Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $50 mil lion in 2010, 

($150 mil lion by 2013). They fore cast sales of $80 mil lion in 2009 for Afinitor ($300 mil lion by 2013). 



EXTAVIA (in ter feron beta-1b ): In May 2008, Novartis’ biosimilar prod uct Extavia (in ter feron beta-1b) 

was ap proved in the EU for the treat ment of early and re laps ing forms of mul ti ple scle ro sis (MS). It was 

launched in Ger many and Den mark in Jan u ary 2009. Fur ther Eu ro pean launches are planned for 2009. 

The agent is ap proved for re laps ing-re mit ting MS and for pa tients who have ex pe ri enced a sin gle ep i sode 

in volv ing loss of my elin, pa tients who have an ac tive in flam ma tory pro cess need ing in tra ve nous 

corticosteroid treat ment, and pa tients who are at high risk of de vel op ing clin i cally def i nite MS. Novartis 

plans to launch Extavia in the USA in the first half of 2009. 

Novartis and Bayer Schering (the phar ma ceu ti cal arm of Bayer, Ger many) are jointly de vel op ing in ter - 

feron beta-1b as a treat ment for MS. In ter feron beta-1b was launched in the USA, its first world mar ket in 

1993 as a ther apy for re laps ing-re mit ting MS. It is cur rently mar keted world wide by Bayer Schering as 

Betaferon or Betaseron. In 2007, Bayer Schering and Novartis signed a deal fol low ing the lat ter’s ac qui si - 

tion of Chiron, which al lows Novartis to mar ket its own branded interferon beta-1b. 

Pat ents: In Oc to ber 1982, Cetus, an af fil i ate of the US com pany Chiron (now part of Novartis), filed a 

pri or ity prod uct pat ent ap pli ca tion in the USA. In Feb ru ary 1986, Cetus and Tri ton Bio sci ences, a sub sid - 

iary of Shell, formed a joint ven ture, Tritus, to de velop the prod uct. In 1990, Tri ton Bio sci ences was ac - 

quired by Schering AG (now Bayer Schering) and merged with Schering AG’s US sub sid iary, Berlex. In 

1993 Schering AG and Chiron signed an agree ment re lat ing to the reg u la tory fil ing, de vel op ment and 

sup ply of in ter feron beta-1b. In Sep tem ber 2007, Bayer Schering and Novartis signed an agree ment that 

al lows Novartis to mar ket its own branded interferon beta-1b product. 

Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $25 mil lion in 

2008 ($195 mil lion by 2013). 

FEMARA (letrozole), a po tent, oral, non-steroidal aromatase in hib i tor, was launched in the UK, its first 

world mar ket, in 1996. It is now avail able in over 90 coun tries, in clud ing the USA, Can ada and Ja pan, 

where li censee Chugai launched it in 2006. This once-a-day ther apy was first ap proved as a sec ond-line 

treat ment for breast can cer in post-meno pausal women in whom antiestrogen ther apy has failed. 

Aromatase in hib i tors act by re duc ing the amount of es tro gen cir cu lat ing in the body by bind ing to the en - 

zyme aromatase, which is in volved in the syn the sis of es tro gen in tis sues such as fat, liver and mus cle. 

Use as a first-line ther apy for ad vanced hor mone-de pend ent breast can cer in postmenopausal women 

was approved in the USA and Europe in 2001. 

In 2004, the FDA ap proved letrozole for the ex tended adjuvant treat ment of postmenopausal women 

with early breast can cer who have re ceived post-sur gery tamoxifen ther apy for five years. Letrozole was 

ap proved for this in di ca tion in more than 40 coun tries. These ap prov als were based on re sults from an in - 

ter na tional 5,200-pa tient study (des ig nated MA-17). Af ter five years of tamoxifen ther apy, ben e fits be - 

gin to wane and the risks of endometrial can cer, pul mo nary em bo lism and stroke in crease; how ever, the 

risk of breast can cer re mains and Femara is the first hor monal ther apy to of fer a post-tamoxifen op tion to 

re duce the risk of breast cancer recurrence. 

In 2005, ini tial data from the BIG 1-98 study showed Femara pro vided a dis ease-free sur vival ad van tage 

over tamoxifen in the adjuvant treat ment (post-sur gery) of early breast can cer. Ap proval for this in di ca - 

tion was granted in the USA in 2006, based on the re sults of the BIG 1-98 study, which showed that 

Femara re duced the risk of breast can cer re turn ing by an ad di tional 21% over the re duc tion of fered by 

tamoxifen. Ap proval in the EU also came in the first quarter of 2006. 

Li cens ing: Un der the terms of a 1994 cross-li cens ing deal, Novartis and Chugai (Ja pan) co-de vel oped 

and co-mar ket letrozole in Japan. 

Pat ents: Mylan (USA) re ceived ten ta tive ap proval for a ge neric ver sion of Femara in May 2007. Novartis 

has a com pound pat ent on Femara un til 2011 and filed a pat ent in fringe ment law suit against Mylan in 



2006. In De cem ber 2008, Novartis and Mylan en tered a set tle ment agree ment, un der which Mylan has a 

pat ent li cense that will en able it to mar ket letrozole tab lets 2.5 mg prior to the ex pi ra tion of the pat ent. 

Ad di tional terms of the agreement remain undisclosed. 

Clin i cal Data: Re sults of the Breast In ter na tional Group (BIG) 1-98 trial were pub lished in 2005 in The 

New Eng land Jour nal of Med i cine. This trial, in which 8,000 pa tients who un der went sur gery for early 

breast can cer were ran dom ized to re ceive adjuvant ther apy with ei ther tamoxifen or letrozole, showed 

that letrozole pro vided sig nif i cantly greater ben e fit than tamoxifen with re spect to dis ease-free sur vival 

and re duc ing the spread of the dis ease. Fur ther anal y sis of re sults from this trial dem on strated that, at 

me dian fol low-up of pa tients at 26 months, letrozole pro longed dis ease-free sur vival by re duc ing the risk 

of re cur rence by an ad di tional 21% com pared with tamoxifen. In ad di tion, women treated with letrozole 

had a 27% re duc tion in dis tant metastases as well as a 14% re duc tion in the risk of death, although this 

did not reach statistical significance. 

In De cem ber 2008 pos i tive data was re ported in a trial com bin ing GlaxoSmithKline’s Tykerb (lapatinib) 

and Femara in breast can cer treat ment. The study, con ducted by GSK, found a sub set of pa tients with 

ag gres sive HER-2 pos i tive met a static breast can cer given the com bi na tion had a lon ger time to dis ease 

pro gres sion com pared to Femara treat ment alone (8.2 mo vs 3 mo). 

Com pe ti tion: Femara’s clos est com pet i tor is AstraZeneca’s aromatase in hib i tor Arimidex 

(anastrozole) as they are both ap proved for the first-line treat ment of breast can cer in postmenopausal 

women with ad vanced, hor mone re cep tor-pos i tive dis ease and both have shown su pe ri or ity over the 

older, gold stan dard treat ment for this pa tient pop u la tion, AZ’s Nolvadex (tamoxifen). 

In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Femara was num ber three 

prod uct in the Cyto Hor mone An tag o nists class (L2B), with a 19.1% mar ket share and 20% fixed rate 

dol lar growth. AstraZeneca’s Arimidex (anastrozole) led this class, with a 34.2% mar ket share and 9% 

fixed rate dol lar growth. Num ber two was AstraZeneca’s Casodex (bicalutamide), a treat ment for pros - 

tate can cer, with a 24.3% mar ket share but sales down 1% in fixed rate dol lar terms. Pfizer’s Aromasin 

(exemestane) was num ber four, with an 8.0% mar ket share and 11% fixed rate dol lar growth. Num ber 

five was AstraZeneca’s breast can cer drug Faslodex (fulvestrant), with a 4.1% mar ket share and 8% 

fixed rate dol lar growth. Nolvadex was in sixth place, with a 1.5% mar ket share, but sales down by 3% in 

fixed rate dollar terms. 

Sales/An a lyst Com ment: In 2008, Femara sales were $1.1 bil lion, up 17% in lo cal cur rency terms, 

and it was Novartis’ num ber four prod uct. US sales rose 18% to $483 mil lion. In the rest of the world sales 

rose 17% to $646 mil lion. Ge neric com pe ti tion has en tered some mar kets, in clud ing mar kets in Eu rope, 

but Novartis notes that this has had a mod est im pact on global growth. Mor gan Stan ley an a lysts (Jan u ary 

2009) fore cast sales of $1,238 mil lion in 2009, peak ing at $1,409 mil lion in 2011 ($508 mil lion by 2014). 

Cowen & Co an a lysts (Au gust 2008) fore cast sales of $937 mil lion in 2008 and think that sales will peak at 

$1,400 mil lion in 2010 (reach ing $300 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe riod to the 

end of Sep tem ber 2008, Femara was Novartis’ num ber six in ter na tional phar ma ceu ti cal prod uct ac - 

count ing for 2.8% of au dited cor po rate pharmaceutical sales, with 21% fixed rate dollar growth. 

GLIVEC/GLEEVEC (imatinib), an Ab1 ty ro sine kinase in hib i tor, was first launched in the USA in 2001 for 

chronic myeloid leu ke mia as Gleevec. It is now avail able in more than 80 coun tries world wide, in clud ing 

Can ada, Aus tra lia, Eu rope, Ja pan, Asia, and Latin Amer ica. It was first in di cated in the blast cri sis, ac cel - 

er ated and chronic phases of the dis ease af ter in ter feron-al pha ther apy has failed. It was granted 

fast-track ap proval in the USA fol low ing pos i tive re sults which in di cated that imatinib ef fec tively turns off 

this rel a tively rare but fa tal can cer. In some parts of the world, it is sold as Glivec, which is the IMS 

international pharmaceutical product name. 



In 2002, it was also ap proved in the USA and Eu rope for the treat ment of unresectable and/or ma lig nant 

gas tro in tes ti nal stromal tu mors (GIST). It was ap proved for this in Ja pan in 2003. A warn ing of po ten tial 

risk of gas tro in tes ti nal per fo ra tion when used in this in di ca tion was added in mid-2004. In 2002, it was 

ap proved in Eu rope and the USA for use in as a first-line treat ment in early stage CML, and, on the ba sis of 

the IRIS study data, some ex perts al ready con sider Glivec to be the stan dard of care for early CML. Can - 

ada ap proved its use in newly di ag nosed CML in 2003. The FDA ex tended its in di ca tion to cover pe di at ric 

use in Phil a del phia-pos i tive chronic myeloid leu ke mia in 2003, and also ap proved its use in pe di at ric CML. 

In 2006, Novartis re ceived ap proval for Glivec in the US and Eu rope in four rare can cers: 

dermatofibrosarcoma protuberans, cer tain forms of myeloproliferative dis or ders (MPD), 

hypereosinophilic syn drome and sys temic mastocystosis, but in Oc to ber 2006 Novartis with drew its fil ing 

in Eu rope for the treat ment of sys temic mastocytosis. The EMEA ad vi sory com mit tee had stated that it 

did not have enough data to make a judgment on the benefit-risk balance of Glivec for this indication. 

Glivec has three modes of ac tion: in CML it in hib its the bcr-abl ty ro sine kinase; in GIST it tar gets the Kit 

pro tein pro duced by the c-kit gene; and in cer tain solid tu mors, Glivec acts on the platelet-de rived growth 

fac tor (PDGF) re cep tor to pro duce ar rest of the cell cycle. 

In 2005, a study pre sented at the ASCO meet ing showed that pa tients with GIST who have a par tic u lar 

ge netic mu ta tion are more likely to re spond to Glivec than those with out the mu ta tion. The re sults con - 

firm pre vi ous ob ser va tions and pro vide a foun da tion for mo lec u lar test ing that can pre dict who will best 

re spond to treatment with the product. 

In 2006, Glivec’s la bel was up dated to in clude re ports of se vere con ges tive heart fail ure and left ven tric u - 

lar dys func tion. This pre cau tion could have a neg a tive im pact on future sales. 

Clin i cal Data: The piv otal study for Glivec was the IRIS (In ter na tional Ran dom ized study of In ter feron 

vs. STI 571) trial, which took place at 177 cen ters in 16 coun tries, com par ing imatinib with stan dard al - 

pha in ter feron plus cytarabine as first line ther apy in 1,106 pa tients with newly di ag nosed Bcr-Abl pos i - 

tive CML. Data was pre sented from this trial in Jan u ary 2002 (pre lim i nary re sults), De cem ber 2002 (18 

month data) and De cem ber 2004 (42 month data). All the data was highly pos i tive, with ini tial re sults 

show ing that pa tients treated with imatinib, 77% showed com plete or ma jor cytogenetic re sponses, with 

a hematological response rate of 98%. 

Data pre sented at the 2006 ASCO meet ing showed that 89% of CML pa tients who were treated with 

Glivec were alive af ter five years, com pared to no more than 50% sur vival rate with other ther a pies. In 

Jan u ary 2009 Novartis noted that data from the IRIS trial showed that nearly 90% of CML pa tients in the 

study were still alive seven years af ter di ag no sis fol low ing treat ment with Glivec: this is the lon gest over - 

all sur vival ob served to date in this disease. 

In 2006, Novartis an nounced re sults from pre clin i cal stud ies of imatinib for the treat ment of rheu ma toid 

ar thri tis. In vivo stud ies showed that imatinib damped down sev eral as pects of the im mune sys tem, in - 

clud ing tu mor ne cro sis fac tor-al pha re lease, macrophage and mast cell pro duc tion, and pro duc tion of 

B-cells; cells known to build up in the joints of pa tients with rheumatoid arthritis. 

In Oc to ber 2008, Novartis re ported pre lim i nary re sults from a phase II proof-of-con cept study of imatinib 

in the treat ment of pul mo nary ar te rial hy per ten sion (PAH). The dou ble-blind, pla cebo-con trolled, 

multicenter trial en rolled 59 pa tients with PAH. The trial aimed to eval u ate the safety and ef fi cacy of 400 

mg imatinib in pa tients who had pre vi ously failed to im prove fol low ing stan dard treat ment with 

prostanoids, endothelin an tag o nists or PDE-V in hib i tors. Re sults showed a sig nif i cant im prove ment in 

pul mo nary vas cu lar re sis tance and a nu mer i cal in crease in car diac out put. Im prove ments in the six-min - 

ute walk test were observed but these did not reach statistical significance. 

Pat ents: Pat ents run to 2013 in most mar kets (2016 in Aus tra lia) and 2016 in Eu rope. 



In In dia, Novartis has been fight ing to have its pat ent pro tec tion for Glivec rec og nized and en forced. In dia 

in tro duced a new pat ent re gime in 2005 to com ply with the WTO agree ment on trade re lated as pects of 

in tel lec tual prop erty rights that rec og nizes pat ents for chem i cal prod ucts filed there af ter 1995. In March 

2004, Novartis was vic to ri ous in its first bat tle to pro tect Glivec from ge neric com pe ti tion in In dia; the 

High Court in Ma dras has is sued an in junc tion stop ping mar ket ing of ge neric lines and four man u fac tur ers 

im me di ately with drew their ver sions (Cipla, Ranbaxy, Intas and Sun Pharma). In Oc to ber 2004, Novartis 

reached an out-of-court set tle ment with two In dian com pa nies (Natco and Natchem), who have agreed 

they will not im port their ge neric ver sion of imatinib called Veenat 100 into coun tries cov ered by the Eu - 

ro pean pat ent. In 2006, the In dian Pat ent Of fice ter mi nated the ex clu sive mar ket ing rights granted to 

Novartis in 2003 for Glivec and re fused to pro ceed fur ther with Novartis pat ent ap pli ca tion for Glivec, fol - 

low ing op po si tion by sev eral do mes tic firms in clud ing Cipla, Natco Pharma and NGO Can cer Pa tients Aid 

As so ci a tion. Novartis ar gued that the ap pli ca tion was for a new sub stance, but the claim was re jected. 

The Of fice of Con trol ler of Pat ents ruled that the pat ent ap plied for by Novartis did not qual ify as an in ven - 

tion on the grounds that it is merely a modification of the key component of the drug, for which a patent 

had already been filed in 1993. 

In 2007, Novartis ap pealed against the ap point ment of the for mer Pat ent Con trol ler Mr S. 

Chandrasekaran on the In tel lec tual Prop erty Ap pel late Board (IPAB), to look into the case. The con ten - 

tion be ing that the for mer Pat ent Con trol ler was head ing the Pat ent Of fice when it orig i nally re jected 

Novartis’ pat ent ap pli ca tion in Jan u ary 2006. The Ma dras High Court ruled that a two mem ber bench 

com pris ing the Chair man and Vice-Chair man of the IPAB could look into the re jec tion of Novartis’ patent 

application on Glivec. 

In Feb ru ary 2008, it was re ported that Thai land had de cided not to pro ceed with a com pul sory li cense for 

Glivec af ter Novartis of fered to ex pand a scheme for the free sup ply of the prod uct to pa tients cov ered by 

the com pany’s uni ver sal healthcare scheme. 

Lifecycle Man age ment: Novartis is in ves ti gat ing imatinib in phase III tri als in pa tients with CML and for 

the adjuvant set ting in GIST. In De cem ber 2008 imatinib was ap proved by the US FDA for post op er a tive 

treat ment of adult pa tients fol low ing com plete sur gi cal re moval of CD 117-pos i tive GIST. Imatinib was 

granted Pri or ity Re view sta tus by the FDA for this in di ca tion in Au gust 2008. Novartis has filed for ap - 

proval for this in di ca tion in the EU, Swit zer land and other mar kets with launches for the in di ca tion ex - 

pected in 2009. The sub mis sions were based on data from a US and Ca na dian phase III trial, des ig nated 

ACOSOG Z90001, show ing an 89% re duc tion in the risk of GIST re cur rence af ter sur gery in pa tients 

given imatinib com pared with pla cebo. The com pany also re ports phase II stud ies with Glivec in non-on - 

col ogy in di ca tions. Stud ies have no ticed po ten tial for Glivec in Alz hei mer’s dis ease, via low er ing pro duc - 

tion of beta-am y loid thought to un der lie the de vel op ment of the dis ease. In early 2009 Glivec was in 

phase II tri als for pulmonary arterial hypertension with a filing for this indication projected for 2011. 

In No vem ber 2008, it was re ported that Glivec can pre vent the de vel op ment of Type 1 di a be tes in a 

mouse model of the dis ease and in mice al ready with the con di tion, the drug can put the mice into re mis - 

sion which then con tin ues for some time af ter the drug has been stopped. 

Com pe ti tion: Glivec is al ready used as a first-line ther apy in more than 75% of the el i gi ble CML and 

GIST pa tients across all ma jor mar kets and has been vir tu ally alone in the CML space. Com pe ti tion, how - 

ever, is com ing from Bris tol-Myers Squibb’s SRC-ABL kinase in hib i tor Sprycel (dasatinib), which has 

shown ef fi cacy in CML Glivec fail ures and was launched in the USA in 2006. 

Mean while, Pfizer’s multi-tar geted angiogenesis in hib i tor, Sutent (sunitinib), was also de vel oped to treat 

GIST pa tients with Glivec re sis tance. It was ap proved by the FDA in 2006 for met a static re nal cell and 

GIST in di ca tions. An a lysts be lieve it could be come a blockbuster. 



Ac cord ing to IMS, Glivec was the num ber four prod uct in the ‘All Other Antineoplastics’ class in the 

12-month pe riod to the end of Sep tem ber 2008, with a 12.9% mar ket share and 13% fixed rate dol lar 

growth. Roche’s MabThera (rituximab) led the class with a 17.8% mar ket share and 14% dol lar growth, 

fol lowed by Roche’s Avastin (bevacizumab) in sec ond place, with a 15.6% mar ket share and 38% dol lar 

growth. Roche’s Herceptin (trastuzumab) was num ber three, with a 15.4% mar ket share and 12% 

fixed rate dol lar growth. In fifth place was sanofi-aventis’ Eloxatine (oxaliplatin) with a 9.0% mar ket 

share and 2% fixed dol lar rate growth. Sutent was the num ber nine prod uct in the class, with a 3.2% 

mar ket share and 49% fixed rate dol lar growth. BMS’s Sprycel was in num ber 11 po si tion, with a 1.0% 

mar ket share, but 123% fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, Glivec sales were $3.67 bil lion, up 15% in lo cal cur rency terms, 

mak ing it Novartis’ num ber two prod uct. Sales rose 26% in the USA to $902 mil lion, and up 12% in the 

rest of the world to $2,768 mil lion. Novartis noted that it bene fited from wider use in pa tients with GIST 

and in var i ous rare dis eases. Mor gan Stan ley an a lysts (Jan u ary 2009) pre dict 2009 sales of $3,902 mil - 

lion ($4,973 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $3,820 in 2008 

($5,100 by 2013). Ac cord ing to IMS, in the 12 months to the end of Sep tem ber 2008, Glivec was 

Novartis’ num ber two in ter na tional phar ma ceu ti cal prod uct, ac count ing for 8.5% of au dited cor po rate 

phar ma ceu ti cal sales, with 12% fixed rate dollar growth. 

MYFORTIC (mycophenolate so dium), an en teric coated for mu la tion of the so dium salt of mycophenolic 

acid, was ap proved in Swit zer land in 2002 for the pre ven tion of acute re jec tion in kid ney (re nal) trans - 

plant pa tients. Myfortic has since been launched in over 50 mar kets world wide, in clud ing Eu rope, the 

USA, Brazil, Can ada and In dia for use in com bi na tion with stan dard ther a pies (ciclosporin and 

corticosteroids) to pre vent or gan re jec tion in kid ney trans plant pa tients. Ad junc tive ther apy with Roche’s 

MPA prod uct CellCept (mycophenolate mofetil) is stan dard in over 70% of new re nal trans plant pa tients. 

How ever, se ri ous GI side ef fects (some times lead ing to dis con tinu a tion of ther apy) are seen with 

CellCept, and Myfortic has a better GI side-ef fect pro file due to its en teric coat ing, mean ing it is ab sorbed 

in the small in tes tine rather than the stom ach. Data from 11 tri als con ducted in Eu rope, in volv ing 877 re - 

nal trans plant pa tients were col lected and Myfortic shows im proved gastrointestinal tolerability compared 

with mycophenolate mofetil. 

In No vem ber 2007, the FDA added a new safety warn ing to Myfortic’s la bel out lin ing the in creased mis - 

car riage risk in the first tri mes ter of preg nancy and raised risk for mal for ma tions of the ex ter nal ear and 

the face, such as cleft lip and pal ate. Other drug-re lated birth de fect risks in clude anom a lies of dis tal 

limbs, which in clude fin gers and toes, and of the heart, esoph a gus, and kid ney. In April 2008, it was re - 

ported that the FDA was re view ing whether Myfortic and a sim i lar Roche drug, CellCept, could be linked to 

a rare CNS dis or der, pro gres sive multifocal leukoencephalopathy (PML). 

Com pe ti tion: Myfortic is tar geted at pa tients tak ing CellCept and ex pe ri enc ing se vere GI side ef fects, as 

well as new kid ney trans plant pa tients. In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing 

to IMS, Myfortic was the num ber eight prod uct in the L4A class (Immunosuppressive Agents), with a 

1.6% mar ket share and 38% fixed rate dol lar growth. Num ber one was J&J’s Remicade (infliximab), 

with a 40.7% mar ket share. Remicade is in di cated in var i ous au to im mune con di tions, but is not a di rect 

com pet i tor in the trans plan ta tion field. Num ber two was Astellas’ Prograf (tacrolimus), with a 15.9% 

mar ket share and 14% fixed rate dol lar growth. Num ber three was Roche’s CellCept (mycophenolate 

mofetil), with a 14.9% mar ket share and 12% dol lar growth. Num ber four was Novartis’ Sandimmun 

(ciclosporin), with a 7.7% mar ket share but sales down 3% in fixed rate dol lar terms. Num ber five was 

Celgene’s Revlimid (lenalidomide), also not a com pet i tor to Myfortic, with a 4.5% mar ket share and 

240% fixed rate dol lar growth. Num ber six was Biogen Idec’s Tysabri (natalizumab), which is used in 

MS, with a 3.9% mar ket share and 249% fixed rate dol lar growth. Num ber seven was Wyeth’s 

Rapamune (sirolimus), with a 2.5% mar ket share and 1% dol lar growth. Novartis’ Certican 

(everolimus) was the num ber 12 prod uct world wide with a 0.6% market share and 48% fixed rate dollar 

growth. 



Sale/An a lyst Com ment: In 2008, Novartis re ported that sales stood at $290 mil lion, up 47% in lo cal 

cur rency terms, mak ing it Novartis’ num ber 20 prod uct. Cowen & Co an a lysts (Au gust 2008) fore cast 

sales of $320 mil lion in 2008 ($525 mil lion by 2013). 

SANDIMMUN/NEORAL (ciclosporin), an immunosuppressant, was first launched as Sandimmun in 

1983. A newer for mu la tion, Neoral, a pat ented soft gel cap sule that of fers more pre dict able re lease 

char ac ter is tics and better bioavailability than stan dard Sandimmun, has now been launched in many 

mar kets. Ciclosporin is mainly used in pre vent ing or gan trans plant re jec tion, but is also used for pso ri a - 

sis, ne phritic syn drome, der ma ti tis, uveitis and rheu ma toid ar thri tis in a num ber of mar kets, in clud ing 

the USA. Neoral was launched in Ja pan in 2000 and Novartis re ceived ap proval in Ja pan for the drug in 

my as the nia gra vis in 2006. Sandimmun is gradually being replaced by Neoral. 

Li cens ing: Ciclosporin was li censed-out to Allergan (USA) in 1993 for top i cal oph thal mic uses world wide 

out side Ja pan and cer tain other Asian coun tries. 

Pat ents: Ciclosporin is now a ma ture drug and open to ge neric com pe ti tion. Abbott has a branded ge - 

neric ver sion called Gengraf, and Eon Labs and Apotex also mar ket sig nif i cant ge neric ver sions of 

ciclosporin. The Neoral for mu la tion is pro tected by new pat ents, but it is re ported that these will ex pire 

before 2008. 

Lifecycle Man age ment: Neoral’s in di ca tions have now been ex panded to in clude the treat ment of pso - 

ri a sis, uveitis, se vere atopic der ma ti tis, nephrotic syn drome and RA. Novartis is now de vel op ing suc ces - 

sors to ciclosporin. It also aims to de fend its fran chise through the de vel op ment of NeoralChek, a 

di ag nos tic in clin i cal tri als for mon i tor ing plasma lev els of the drug to al low tai lored, in di vid u al ized ther - 

apy. Tri als have al ready shown that use of NeoralChek has im proved out comes in liver trans plant pa - 

tients, and studies are also planned in kidney transplants. 

Com pe ti tion: The launch of newer immunosuppressants, such as Astellas’ Prograf (tacrolimus) has 

put pres sure on Neoral. In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, 

Sandimmun was the num ber four prod uct world wide in the immunosuppressive agents class (L4A), 

with a 7.7% mar ket share but sales down 3% in fixed rate dol lar terms. Num ber one was J&J’s 

Remicade (infliximab), with a 40.7% mar ket share and sales up 16% in fixed rate dol lar terms. It is in di - 

cated in var i ous au to im mune con di tions, but is not a di rect com pet i tor to Sandimmun in the trans plan ta - 

tion field. Num ber two was Astellas’ Prograf (tacrolimus), with a 15.9% mar ket share and 14% fixed 

rate dol lar growth. Num ber three was Roche’s CellCept (mycophenolate mofetil), with a 14.9% mar ket 

share and 12% dol lar growth. Num ber five was Celgene’s Revlimid (lenalidomide), with a 4.5% mar ket 

share and 240% fixed rate dol lar growth: this is also not a di rect com pet i tor to Sandimmun as it is in di - 

cated for myelodysplastic syn drome. Num ber six was Biogen Idec’s Tysabri (natalizumab), which is 

used in MS, with a 3.9% mar ket share and 249% fixed rate dol lar growth. Num ber seven was Wyeth’s 

Rapamune (sirolimus), with a 2.5% mar ket share and 1% dol lar growth. Num ber eight was Novartis’ 

Myfortic (mycophenolic acid), with a 1.6% mar ket share and 38% fixed rate dol lar growth. Novartis’ 

Certican (everolimus) was the num ber 12 prod uct world wide in the class, with a 0.6% market share and 

48% fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, Novartis re ported that Sandimmun/Neoral sales were $956 mil - 

lion, down 4% in lo cal cur rency terms, and it was its num ber six prod uct. In the USA sales fell 9% to $98 

mil lion, and in the rest of the world sales were down 4% at $858 mil lion. Mor gan Stan ley an a lysts (Jan u - 

ary 2009) fore cast sales of $869 mil lion in 2009 ($672 mil lion by 2014). Cowen & Co an a lysts (Au gust 

2008) fore cast sales of $1,030 mil lion in 2008 ($900 mil lion by 2013). Ac cord ing to IMS, in the 12-month 

pe riod to the end of Sep tem ber 2008, Sandimmun was Novartis’ num ber eight in ter na tional prod uct ac - 

count ing for a 2.4% share of au dited cor po rate phar ma ceu ti cal sales, but sales were down 3% in fixed 

rate dollar terms. 



SIMULECT (basiliximab), a monoclonal an ti body for the pro phy laxis of acute re jec tion ep i sodes fol low - 

ing re nal trans plan ta tion, was launched in Swit zer land and the USA in 1998. It has sub se quently been 

launched in most Eu ro pean coun tries and in Ja pan. Basiliximab in hib its white blood cell pro lif er a tion by 

block ing interleukin-2 re cep tors. It is de signed to work with Novartis’ immunosuppressant Neoral 

(ciclosporin). The US CMS ac cepted Simulect as one of seven new prod ucts el i gi ble for payment as 

Orphan Drugs. 

Li cens ing: In 2006, Cerimon (USA) ac quired ex clu sive world wide rights to basiliximab for the treat ment 

of in flam ma tory bowel dis ease (IBD). Un der the terms of the deal, Cerimon will be re spon si ble for de vel - 

op ment and mar ket ing of the prod uct for IBD; Novartis will con tinue to mar ket the prod uct for trans plant 

re jec tion. Cerimon will re ceive per for mance-based mile stones from Novartis and, af ter reg u la tory ap - 

proval, will share rev e nue from net sales of basiliximab with Novartis. 

Lifecycle Man age ment: Cerimon has con ducted an early proof-of-con cept clin i cal trial of basiliximab in 

the treat ment of IBD and be gan phase IIb tri als in ul cer ative co li tis in 2007. In July 2008, it an nounced 

that it has ini ti ated a phase II proof-of-con cept study for the treat ment of non-in fec tious uveitis, a chronic 

and po ten tially sight-threat en ing in flam ma tion of the eye. 

In March 2008, Cerimon an nounced that it has en tered into an agree ment with Novartis to con duct a 

proof-of-con cept study for basiliximab for the treat ment of non in fec tious uveitis, an au to im mune in flam - 

ma tion of the in ter nal struc tures of the eye. 

TASIGNA (nilotinib), an orally ac tive in hib i tor of ty ro sine kin ases, such as BCR-ABL and mu tant forms of 

BCR-ABL, was launched in Swit zer land, its first world mar ket, in Au gust 2007 for the treat ment of pa - 

tients with ad vanced chronic myelogenous leu ke mia (CML) who do not re spond to Glivec (imatinib). 

Tasigna was launched in the USA in Oc to ber 2007. 2007 also saw launches in South Ko rea, In do ne sia and 

Mex ico. It was ap proved in No vem ber 2007 in all 27 mem ber states of the EU plus Nor way and Ice land. 

2008 saw launches in Ger many, Aus tria, France, Nor way, Fin land, Swe den, Den mark the UK, the Czech 

Re pub lic, the Phil ip pines, Po land, Ire land, Greece, Bel gium, Spain, the Slo vak Re pub lic and Can ada. 

Tasigna is now ap proved in about 40 coun tries. It was sub mit ted for ap proval in Ja pan in June 2007 and 

was ap proved in Jan u ary 2009. The FDA has granted Tasigna Or phan Drug sta tus in the USA, and the 

EMEA has granted the product Orphan Medicinal Product status in the EU. 

Tasigna was de signed to be a more po tent and se lec tive in hib i tor of Bcr-Abl, the cause of Ph+ CML, and 

its mu ta tions than Glivec. Sep a rate phase III stud ies are un der way com par ing Tasigna and Glivec in 

newly di ag nosed CML pa tients as well as those with sub-op ti mal re sponses to pre vi ous ther apy. A reg is - 

tra tion study is also un der way in pa tients with gas tro in tes ti nal stromal tu mors (GIST) who are re sis tant 

or intolerant to prior treatment. 

Clin i cal Data: In De cem ber 2008 at the Amer i can So ci ety of He ma tol ogy re sults were pre sented of two 

phase II tri als in newly di ag nosed pa tients with Phil a del phia chro mo some-pos i tive chronic myeloid leu ke - 

mia (Ph+ CML). In both phase II stud ies, 96% of pa tients with Phil a del phia chro mo some-pos i tive chronic 

myeloid leu ke mia (Ph+ CML) achieved a com plete cytogenetic re sponse (CCyR) af ter six months of 

Tasigna treatment. 

Com pe ti tion: In 2006, Bris tol-Myers Squibb launched Sprycel (dasatinib) in the USA and the EU for the 

treat ment of CML and Phil a del phia-pos i tive ALL in Glivec-re sis tant pa tients. This prod uct was al ready 

num ber ten in the All Other Antineoplastics class (L1X) in the 12-month pe riod to the end of Sep tem ber 

2008, with a 1.0% mar ket share, but 123% fixed rate dol lar growth. Sales stood at around $236 mil lion, 

according to IMS. 

Sales/An a lyst Com ment: Sales in 2008 were $89 mil lion. Novartis re ports that it has quickly gained 

ac cep tance as a new ther apy in the sec ond-line set ting. The com pany be lieves it shows po ten tial to be - 



come a lead ing treat ment for cer tain newly di ag nosed CML pa tients based on new data that was pre - 

sented in De cem ber 2008. Cowen & Co an a lysts (Au gust 2008) fore cast sales of $65 mil lion in 2008 

($400 million by 2013). 

Blood and Blood-Forming Organ Agents 

BINOCRIT (epoetin alfa) is a re com bi nant eryth ro poi e tin for the treat ment of ane mia as so ci ated with 

chronic kid ney dis ease and ane mia as so ci ated with can cer che mo ther apy, and for the re duc tion of blood 

trans fu sion re quire ments in on col ogy pa tients and prior to elec tive or tho pe dic sur gery. Binocrit was de - 

vel oped by Novartis’ Sandoz af fil i ate as a biosimilar to Amgen/J&J’s Procrit/Erypo. The Eu ro pean Com - 

mis sion granted ap proval for Binocrit as a biosimilar me dic i nal prod uct in the EU in Au gust 2007 for use in 

the treat ment of re nal ane mia and ane mia as so ci ated with can cer che mo ther apy. Binocrit was launched 

by Sandoz in the Neth er lands in Au gust 2007, in Ger many in Oc to ber 2007 and in Aus tria in No vem ber 

2007. It was launched in the UK in April 2008 and in Bel gium in Au gust 2008. In its 2007 an nual re port, 

Novartis com mented, “As an af ford able, high qual ity biogeneric, epoetin alfa could be used to provide 

benefits to approximately 250,000 patients in Europe. 

CLOPIDOGREL-HEXAL (clopidogrel): Novartis’ Hexal generics unit launched its ge neric ver sion of the 

sanofi-aventis anticlotting drug Plavix in Ger many in Au gust 2008. The ge neric ver sion of clopidogrel was 

de vel oped by the Swiss com pany Acino, which has li censed it out to Novartis and to ratiopharm (Ger - 

many). ratiopharm also launched its ge neric clopidogrel prod uct in Ger many in Au gust 2008. Al though 

Plavix pat ents run un til 2013 in many Eu ro pean coun tries, Acino is re ported to have de vel oped a ver sion 

based on a dif fer ent kind of clopidogrel chem i cal salt, which does not vi o late the pat ents. An a lysts note 

that al ter na tive salts are substitutable in Eu rope, but not in the USA. Acino is re ported to be plan ning to 

seek ap proval for its ge neric through out Eu rope. De spite an ap peal by sanofi-aventis against a Ger man 

court’s de ci sion in July 2008 to al low ge neric Plavix onto the mar ket, the de ci sion was up held in Au gust 

2008 and an ap peal by sanofi-aventis was re jected in Sep tem ber 2008. Novartis has stated that it will sell 

ge neric clopidogrel in Germany at around a 25% discount to the branded product. 

Cardiovascular System Agents 

LOTENSIN/CIBACEN (benazepril), an ACE in hib i tor in di cated in the treat ment of hy per ten sion, first 

launched in Den mark in 1990, and now avail able in many mar kets world wide, in clud ing the USA (as 

Lotensin) and Ja pan. It is now open to ge neric com pe ti tion. Lotensin is also avail able in com bi na tion with 

Pfizer’s cal cium-chan nel blocker Norvasc (amlodipine) as Lotrel and with the di uretic hy dro chlo ro thi a - 

zide as Cibadrex. 

Li cens ing: In 2005, Novartis granted Meda AB (Swe den) ex clu sive rights to Cibacen and Cibadrex in 

most Eu ro pean mar kets in ex change for a cash pay ment of $135 million. 

CO-DIOVAN (valsartan + hy dro chlo ro thi a zide) was first launched in Ger many in 1997 for the treat ment 

of hy per ten sion and is now avail able world wide. It was launched in the USA in 1998 as Diovan HCT for 

the sec ond-line treat ment of hy per ten sion. The com bi na tion of the an gio ten sin II an tag o nist valsartan 

and the di uretic hy dro chlo ro thi a zide of fers greater blood pres sure low er ing than monotherapy. New 

higher dose for mu la tions (160/25mg and 160/12.5mg) were launched in 2002. There is now a trend to - 

wards us ing the com bi na tion prod uct as a first-line treat ment. In Au gust 2008 Novartis re ported that 

Diovan HCT had been ap proved in the USA as a first-line treat ment in pa tients likely to re quire mul ti ple 

drugs to con trol their blood pres sure. In Jan u ary 2009 it was approved in Japan, where it will be sold as 

Co-Dio. 

Li cens ing: In 2006, Novartis and LG Life Sci ences signed a deal to co-mar ket Co-Diovan in South Ko rea 

as Co-Tareg. 



Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008 the C9D class (An gio ten sin II An - 

tag o nists, Com bi na tions), was led by Co-Diovan (valsartan + hy dro chlo ro thi a zide), with a 28% mar ket 

share and 14% fixed rate dol lar growth, ac cord ing to IMS. Num ber two was Merck & Co’s Hyzaar 

(losartan + hy dro chlo ro thi a zide), with a 16.9% mar ket share and 11% fixed rate dol lar growth. Num ber 

three was sanofi-aventis’ Coaprovel (irbesartan + hy dro chlo ro thi a zide), with an 8.8% mar ket share 

and 15% fixed rate dol lar growth. Num ber four was Bris tol-Myers Squibb’s Avalide (irbesartan + hy dro - 

chlo ro thi a zide), with a 7.5% mar ket share and 10% fixed rate dol lar growth. Num ber five was 

AstraZeneca’s Atacand Plus (candesartan cilexetil + hy dro chlo ro thi a zide), with a 6.9% mar ket share 

and 7% dol lar growth. Num ber six was Daiichi Sankyo’s Benicar HCT (olmesartan medoxomil + hy dro - 

chlo ro thi a zide), with a 6.9% mar ket share and 31% dol lar growth. Num ber seven was Boehringer 

Ingelheim’s Micardis HCT (telmisartan + hy dro chlo ro thi a zide), with a 6.0% market share and 25% 

dollar growth. 

Sales/An a lyst Com ment: Diovan/Co-Diovan was Novartis’ num ber one brand in 2008 with sales of 

$5.7 bil lion ($3.3 bil lion from the US), up 15%. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast sales of 

$5,819 mil lion in 2009, peak ing at $5,834 mil lion in 2010 ($1,264 mil lion by 2014). Cowen & Co an a lysts 

(Au gust 2008) fore cast $5,985 mil lion in 2008 and think sales will peak at $6,405 mil lion in 2009 ($1,500 

mil lion by 2013). Ac cord ing to IMS, in the 12 month pe riod to the end of Sep tem ber 2008 Co-Diovan was 

Novartis’ num ber three in ter na tional prod uct ac count ing for a 6.8% share of rev e nue with 14% fixed rate 


DIOVAN (valsartan), an an gio ten sin II an tag o nist/an gio ten sin re cep tor blocker (ARB), was first 

launched in Ger many by Novartis for the treat ment of hy per ten sion in 1996. It is now avail able in around 

90 coun tries world wide for this in di ca tion, in clud ing Eu rope, the USA, Latin Amer ica, Ja pan and China. In 

2002, the FDA ap proved Diovan as a treat ment for heart fail ure in pa tients who are in tol er ant to ACE in - 

hib i tors. Ap proval for this in di ca tion was re ceived in Swit zer land in 2003. In 2005, Novartis re ceived an 

ap prov able let ter from the FDA for its sNDA seek ing ap proval for im prov ing sur vival and re duc ing car dio - 

vas cu lar events in pa tients at high risk af ter sur viv ing a heart at tack. Ap proval was granted in Au gust 

2005. Diovan has re ceived ap proval for this in di ca tion in more than 50 coun tries, in clud ing the EU. In De - 

cem ber 2004, the drug was ap proved in Swe den, which acted as the ref er ence mem ber state for ap prov - 

als, in May 2005, in 14 EU states plus Ice land via the mu tual rec og ni tion pro ce dure. The fil ing was based 

on the re sults of the VAL IANT trial, which dem on strated the com pa ra ble ef fi cacy of Diovan and ACE in hib - 

i tor Captopril, in this indication. 

Novartis an nounced in De cem ber 2007 that the FDA had ap proved Diovan for the treat ment of hy per ten - 

sion in chil dren and ad o les cents aged 6-16 years, fol low ing a pri or ity review. 

In March 2008, Health Can ada ap proved Diovan for the treat ment of chronic heart fail ure in pa tients who 

can not tol er ate ACE in hib i tors. 

Li cens ing: In 1999, Schwarz (Ger many, now part of UCB, Bel gium) ac quired Ger man co-mar ket ing 

rights for valsartan from Novartis, and launched the drug as Provas/Provas Comp. Novartis will con - 

tinue to mar ket Diovan in Ger many. Provas Comp is a com bi na tion with hy dro chlo ro thi a zide. The deal 

with Schwarz was later ex tended to cover Spain. In It aly, valsartan is co-mar keted by Novartis and 

Menarini (It aly). In 2000, Novartis and Choong-Wae (South Ko rea) agreed to co-pro mote Diovan in 

South Ko rea. In 2003, Ipsen (France) ob tained rights to mar ket valsartan (Nisis) in France, where it was 

pre vi ously dis trib uted by Aventis. In Jan u ary 2007, Mochida (Ja pan) and Novartis signed a co-pro mo tion 

agree ment for Diovan in Ja pan, start ing Feb ru ary 2007. How ever this deal was terminated in January 

2009. 

Pat ents: In Au gust 2007, Diovan was granted pe di at ric ex clu siv ity by the FDA based on stud ies con - 

ducted in chil dren with high blood pres sure. This ac tion ex tends mar ket ing ex clu siv ity as so ci ated with the 

valsartan pat ent by six months from March to Sep tem ber 2012. In Oc to ber 2007, Ranbaxy re ceived ten - 



ta tive ap proval by the FDA for ge neric valsartan tab lets. Teva re ceived ten ta tive ap proval for generic 

Diovan in June 2008. 

Clin i cal Data: Diovan acts di rectly on the vas cu lar tis sue, block ing the car dio vas cu lar ef fects of an gio - 

ten sin II, which in clude vasoconstriction and the re lease of aldosterone (a hor mone which pro motes the 

re ten tion of wa ter and so dium in the body) from the adrenal gland. 

Novartis be lieves Diovan may play a role in man ag ing other con di tions be sides hy per ten sion, in clud ing 

con ges tive heart fail ure (CHF), myo car dial in farc tion and di a be tes, where it has been shown to re duce 

microalbuminuria more than ACE in hib i tors. Over 35,000 pa tients have been or are cur rently in volved in 

a va ri ety of tri als. Novartis has com pleted sev eral ma jor tri als as fol lows: Valsartan Heart Fail ure Trial 

(Val-HeFT), which com pared valsartan to pla cebo in 5,010 heart fail ure pa tients re ceiv ing stan dard treat - 

ment and was used to gain the heart fail ure in di ca tion, with sev eral sets of data were re ported from 2000 

to 2003; VAL IANT (Valsartan in Acute Myo car dial In farc tion) trial, which com pared Diovan with the ACE 

in hib i tor captopril in terms of health and sur vival in post-MI pa tients, and in di cated that Diovan is as ef - 

fec tive as captopril in re duc ing mor tal ity in pa tients at high risk of car dio vas cu lar events af ter myo car dial 

in farc tion; MARVAL (Microalbuminuria Re duc tion with Valsartan) trial, a trial of 332 Type 2 di a betic pa - 

tients with microalbuminuria and ei ther nor mal or high blood pres sure who re ceived valsartan or 

amlodipine on top of other antihypertensive ther apy (bendrofluazide and doxazosin), which in di - 

cated that Diovan was a more ef fec tive treat ment than amlodipine for slow ing the pro gres sion of 

microalbuminuria; QoLITY, which found that hy per ten sive pa tients who switched to Diovan or Diovan 

HCT af ter be com ing in tol er ant to com monly pre scribed antihypertensive drugs, ex pe ri enced sig nif i cantly 

im proved qual ity of life while their sys tolic and di a stolic blood pres sure con trol was ad e quately main - 

tained; AADVANCE study, which in di cated that Diovan low ered blood pres sure to ag gres sive rec om - 

mended tar get blood pres sure goals as ef fec tively as amlodipine; and VALUE (Valsartan Antihypertensive 

Long-term Use Eval u a tion), a trial de signed to com pare the long-term ben e fits of Diovan with those of 

Pfizer’s (USA) cal cium an tag o nist Norvasc (amlodipine), in pa tients with es sen tial hy per ten sion with a 

high risk for car dio vas cu lar events which while con firm ing the long-term cardioprotective pro file of 

Diovan, found there was no statistically significant difference between Diovan and Norvasc in reducing 

cardiac mortality and morbidity (the primary endpoint of the trial). 

The NAV I GA TOR (Nateglinide And Valsartan in Im paired Glu cose Tol er ance Out comes Re search) trial, is 

on go ing. This is a mul ti na tional study that will in volve about 7,500 in di vid ual in over 30 coun tries to in - 

ves ti gate whether the oral antidiabetic agent Starlix (nateglinide) or Diovan can pre vent di a be tes and/or 

car dio vas cu lar events in in di vid u als with im paired glu cose tol er ance that are at high risk for 

cardiovascular events. 

Lifecycle Man age ment: In 2007, Novartis launched a fixed-dose com bi na tion of Diovan with 

amlodipine as Exforge. This marked the first com bi na tion of a cal cium chan nel blocker with an ARB, of - 

fer ing a once-daily treat ment with a dual mech a nism of ac tion that com bines the ben e fits of both drugs in 

one pill. Novartis filed a com bi na tion of valsartan and aliskiren for ap proval in the USA in late 2008. Ap - 

proval is expected in 2009. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Diovan was the 

num ber one prod uct in the AIIA class (C9C), with a 26.3% mar ket share and 12% fixed rate dol lar 

growth. Num ber two was Merck & Co’s Cozaar (losartan), with a 16.3% mar ket share, but sales down 

5% in fixed rate dol lar terms. Num ber three was Takeda’s Blopress (candesartan cilexetil) with an 

11.4% mar ket share and 6% dol lar growth. Num ber four was Boehringer Ingelheim’s Micardis 

(telmisartan), with an 8.9% mar ket share and 16% fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, Diovan’s net sales reached $5.7 bil lion (com bined with sales of 

Co-Diovan), up 10% in lo cal cur rency terms and it was Novartis’ num ber one prod uct. Ac cord ing to 

Novartis. sales grew steadily in all key mar kets world wide, with ar eas out side the USA ac count ing for 



about 58% of net sales with 10% growth in lo cal cur rency terms. US sales were re ported to be up 10%. 

Novartis noted that Diovan has bene fited from its sta tus as the only drug in the ARB class ap proved to 

treat high blood pres sure, high-risk heart at tack and heart fail ure. Mor gan Stan ley an a lysts (Jan u ary 

2009) fore cast 2009 sales of $5,819 mil lion, peak ing at $5,834 mil lion in 2010 ($1,264 mil lion by 2014). 

Cowen & Co an a lysts (Au gust 2008) fore cast sales of $5,985 mil lion in 2008. They think sales will peak at 

$6,405 mil lion in 2009 and fall to $1,500 mil lion by 2013. Ac cord ing to IMS, in the 12-month pe riod to the 

end of Sep tem ber 2008, Diovan was Novartis’ num ber one in ter na tional phar ma ceu ti cal prod uct ac - 

count ing for a 9.9% share of au dited cor po rate pharmaceutical sales, with 12% fixed rate dollar growth. 

EXFORGE (valsartan + amlodipine), a fixed-dose com bi na tion of the cal cium chan nel blocker amlodipine 

(Pfizer’s Norvasc) and Novartis’ Diovan (valsartan), was ap proved in Eu rope in Jan u ary 2007 for the 

treat ment of hy per ten sion. In Jan u ary 2007, it was launched in its first world mar kets, Ger many and 

Swit zer land. Later in 2007, it was launched in the USA, the UK, Greece, Ire land, Fin land, Bel gium, Cen - 

tral Amer ica, Aus tria, Nor way, the USA, Den mark, the Neth er lands, France, Ec ua dor, the Do min i can Re - 

pub lic, the Slo vak Re pub lic, South Ko rea, Co lom bia, Chile, In do ne sia, Peru, Leb a non, Ven e zuela, Po land, 

Ar gen tina and Mex ico. In 2008, it was launched in Hun gary, Saudi Ara bia, Por tu gal, Bul garia, Spain, Tur - 

key, and the United Arab Emirates. In Au gust 2008, the US FDA ap proved Exforge as a first-line treat - 

ment for pa tients likely to need mul ti ple drugs to reg u late their blood pres sure. In 2008, Novartis filed for 

approval of Exforge in Japan. 

Ac cord ing to Novartis, Exforge is the first fixed-dose com bi na tion of the two most pre scribed 

anti-hypertensives in the mar ket place, bring ing to gether all the ben e fits of these two lead ing agents in 

one pill. Novartis says that “clin i cal data have shown nine of ten pa tients treated with Exforge reached 

treat ment goals, con firm ing strong ef fi cacy cou pled with im proved con ve nience”. Pre lim i nary data from 

ran dom ized, dou ble-blind phase III tri als con ducted in over 5,000 pa tients with hy per ten sion showed 

that Exforge re duced sys tolic blood pres sure by up to 36mmHg, and di a stolic blood pres sure by up to 

29mmHg. In ad di tion, there was a lower in ci dence of edema in pa tients re ceiv ing the fixed com bi na tion 

prod uct than in patients receiving amlodipine alone. 

Li cens ing: In Jan u ary 2009, Ipsen en tered into a deal with Novartis for the co-pro mo tion of Exforge in 

France as a treat ment for hy per ten sion. 

Lifecycle Man age ment: In Jan u ary 2009 Novartis re ported that it had de vel oped an Exforge plus hy - 

dro chlo ro thi a zide com bi na tion and that it was an tic i pat ing approval in 2009. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Exforge was the num ber eight 

prod uct in the C9D class (An gio ten sin II An tag o nists, Com bi na tions), with a 3.4% mar ket share in its first 

year on the mar ket. The lead ing prod uct in this class was Novartis’ Co-Diovan (valsartan + hy dro chlo ro - 

thi a zide), with a 28% mar ket share and 14% fixed rate dol lar growth. Num ber two was Merck & Co’s 

Hyzaar (losartan + hy dro chlo ro thi a zide), with a 16.9% mar ket share and 11% fixed rate dol lar growth. 

Num ber three was sanofi-aventis’ Coaprovel (irbesartan + hy dro chlo ro thi a zide), with an 8.8% mar ket 

share and 15% fixed rate dol lar growth. Num ber four was Bris tol-Myers Squibb’s Avalide (irbesartan + 

hy dro chlo ro thi a zide), with a 7.5% mar ket share and 10% fixed rate dol lar growth. Num ber five was 

AstraZeneca’s Atacand Plus (candesartan cilexetil + hy dro chlo ro thi a zide), with a 6.9% mar ket share 

and 7% dol lar growth. Num ber six was Daiichi Sankyo’s Benicar HCT (olmesartan medoxomil + hy dro - 

chlo ro thi a zide), with a 6.9% mar ket share and 31% dol lar growth. Num ber seven was Boehringer 

Ingelheim’s Micardis HCT (telmisartan + hydrochlorothiazide), with a 6.0% market share and 25% 


Sales/An a lyst Com ment: Sales of Exforge rose 292% in lo cal cur rency terms in 2008 to $406 mil lion, 

driven by the July 2008 ap proval in the USA and launches in the rest of the world. Exforge rose to be come 

Novartis’ num ber 15 phar ma ceu ti cal prod uct by the end of 2008. Mor gan Stan ley an a lysts (Jan u ary 

2009), fore cast sales of $676 mil lion in 2009 ($874 mil lion in 2011-12). They think sales will fall to $230 



mil lion by 2014. Cowen & Co an a lysts (Au gust 2008) fore cast sales of $450 mil lion in 2008. They think 

sales will peak at $1,050 mil lion in 2011 and fall to $700 million by 2013. 

LESCOL (fluvastatin), a lipid-low er ing agent (HMG CoA reductase in hib i tor), first launched in Swit zer land 

in 1993, and now avail able in over 90 coun tries world wide for the treat ment of pri mary hy per cho les ter ol - 

emia in pa tients who do not re spond ad e quately to di etary con trol. An ex tended-re lease tab let for mu la - 

tion, Lescol XL, was ap proved in the USA in 2000 and is now sold in a num ber of mar kets. Lescol and 

Lescol XL 80mg were ap proved by the FDA in 2003 for re duc ing the risks of cor o nary revascularization 

pro ce dures in pa tients with CHD, and, ac cord ing to Novartis, the prod ucts have al ready re ceived ap - 

proval for the sec ond ary pre ven tion in di ca tion in the UK, Mexico, Germany, and several other key 

markets. 

Li cens ing: AstraZeneca has rights to fluvastatin in 10 coun tries, in clud ing Ger many, the Neth er lands, 

Scan di na via, Mex ico, Aus tra lia, and New Zea land. AZ cur rently mar kets/co-mar kets it as Canef in Swe - 

den, Mex ico, the Neth er lands, Nor way, Por tu gal, Fin land, and Den mark. Ger man rights were sub se - 

quently (2001) li censed to Klinge (Ger many) and Fournier (now part of Sol vay, Bel gium) which 

co-mar ket it as Cranoc. Fluvastatin was be ing co-mar keted in Ja pan with Tanabe Seiyaku (now 

Mitsubishi Tanabe, Ja pan) un der the terms of a 1993 deal, which also in cluded a deal to co-mar ket 

Tanabe’s Tanadopa (docarpamine). In Jan u ary 2008, Novartis and Mitsubishi Tanabe mod i fied their 

fluvastatin li cens ing deal. From March 2008, Novartis will ex clu sively dis trib ute fluvastatin in Ja pan and 

Mitsubishi Tanabe Pharma will ex clu sively man u fac ture the prod uct (for mu la tion and pack ag ing). 

Fluvastatin is mar keted as Lochol in Japan. 

In 2006, Biovail (Can ada) agreed to mar ket Lescol and Lescol XL in Can ada un til 2008. Biovail will pay 

Novartis a fee based on a per cent age of Novartis’ net sell ing price over mu tu ally de ter mined per for mance 

base lines, and has cer tain per for mance ob li ga tions re lated to mar ket ing and pro mo tional ac tiv i ties for the 

products. 

In 2006, Novartis and LG Life Sci ences (South Ko rea) en tered into a deal to co-mar ket ex tended-re lease 

fluvastatin. LG plans to mar ket it as Xilep XL, Novartis will use the name Lescol XL. 

In May 2008, Pi erre Fabre (France) ac quired French co-mar ket ing rights to fluvastatin, sold as Fractal in 

France, from Novartis. 

Pat ents: Lescol pat ents ex pired in Eu rope in 2003, but not un til 2008 in Ja pan (2011 in the USA). In Oc - 

to ber 2008, Mylan (USA) stated that it has been sued by Novartis over its ge neric ver sion of Lescol. Mylan 

said that it be lieved it was the first com pany to file for US ap proval of a ge neric ver sion of Lescol and that 

Novartis filed a law suit on Oc to ber 10 in the US Dis trict Court in New Jer sey al leg ing patent infringement. 

Lifecycle Man age ment: In 2003, Novartis re ceived ap proval from the FDA for the sec ond ary pre ven - 

tion of ad verse CV events in pa tients who have un der gone percutaneous cor o nary in ter ven tion pro ce - 

dures, such as angioplasty. The fil ing fol lowed the com ple tion of the Lescol In ter ven tion Pre ven tion Study 

(LIPS). Novartis has also con ducted a clin i cal trial of Lescol in kid ney trans plant pa tients to in ves ti gate its 

ef fect on car dio vas cu lar dis ease. The trial, known as ALERT (As sess ment of Lescol in Re nal Trans plant), 

com pleted in 2004. Novartis is so cer tain of Lescol’s safety that it is re ported to be under consideration as 

an OTC switch candidate. 

Com pe ti tion: The cho les terol and triglyceride re duc ers class is dom i nated by Pfizer’s Lipitor 

(atorvastatin). In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Lipitor had a 

44.4% mar ket share, but sales were down by 1% in fixed rate dol lar terms. AstraZeneca’s Crestor 

(rosuvastatin) was num ber two with a 12% mar ket share and 29% dol lar growth. Num ber three was 

Merck & Co’s Zetia (ezetimibe), with a 7.9% mar ket share, up 3%. Lescol was the num ber seven prod uct 

in the class, with a 2.1% mar ket share, but sales down by 9% in fixed rate dollar terms. 



Sales/An a lyst Com ment: Lescol sales were $645 mil lion in 2008, down 9% in lo cal cur rency terms, 

and it was Novartis’ num ber ten phar ma ceu ti cal prod uct. Mor gan Stan ley an a lysts (Jan u ary 2009) fore - 

cast sales of $645 mil lion in 2009 ($183 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast 

sales of $640 in 2008 ($100 million by 2013). 

LOPRESOR (metoprolol), a beta-blocker in di cated in the treat ment of an gina, car diac fail ure, and hy per - 

ten sion, and in the pre ven tion of mi graine, was first launched in 1975. It is now avail able in most mar kets 

world wide via Novartis and its part ner AstraZeneca (UK), which mar kets it as Betaloc and Seloken. 

Lopresor is also avail able as a once-daily, slow-re lease for mu la tion as Lopresor SR. Due to ge neric com - 

pe ti tion, sales of Lopresor have fallen in re cent years. Novartis mar kets ge neric ver sions of metoprolol in 

various markets. 

Li cens ing: Metoprolol was li censed-in from AstraZeneca for ex clu sive mar ket ing in the USA and non-ex - 

clu sive mar ket ing in other coun tries. Sankyo Pharma in Ger many has li censed mar ket ing rights in France 

It aly Bel gium, Swit zer land, and Portugal. 

LOTREL (amlodipine + benazepril), a once-daily cal cium-chan nel blocker/ACE in hib i tor com bi na tion in - 

di cated in the treat ment of hy per ten sion in ad e quately con trolled with ACE in hib i tors or cal cium an tag o - 

nists alone, was launched in the USA and Puerto Rico in 1995. It is only avail able on these mar kets. A 

Lotrel 10mg amlodipine/20mg benazepril dos age strength was launched in 2002. 

Li cens ing: Pfizer granted Novartis rights to use its cal cium an tag o nist amlodipine (Norvasc) in com bi - 

na tion with the Novartis ACE in hib i tor benazepril in the USA and It aly. In 2003, Novartis stated that there 

are no plans to launch Lotrel in any mar kets out side the USA. 

Pat ents: Novartis’ pat ent on Lotrel, a com bi na tion prod uct, ex pires in 2017, but amlodipine’s pat ent pro - 

tec tion ex pired in Sep tem ber 2007. In 2004, the FDA re vealed that an un named com pany had filed for 

ap proval of a ge neric ver sion of the drug and the fol low ing month Novartis filed a law suit against Teva (Is - 

rael). Teva re ceived ten ta tive ap proval for its ge neric ver sion of Lotrel in July 2006 and fi nal ap proval in 

May 2007, im me di ately launch ing the ge neric prod uct at risk. Novartis ob tained a tem po rary re strain ing 

or der one day later. Both com pa nies were or dered not to sell or of fer fur ther ge neric prod ucts, be yond 

what had al ready been com mer cial ized, in clud ing any au tho rized generics, un til the next court hear ing in 

late May, when a judge ex tended the tem po rary re strain ing or der. In June, a court de nied a re quest from 

Novartis to stop sales of Teva’s ge neric and al lowed re sump tion of ship ments to cus tom ers. Novartis sub - 

se quently launched its own authorized generic version of Lotrel through Sandoz. 

Clin i cal Data: In De cem ber 2008 fi nal re sults were an nounced from a ran dom ized, dou ble-blind, par al - 

lel-group, multicenter phase III trial, des ig nated AC COM PLISH (Avoid ing Car dio vas cu lar Events through 

COM bi na tion Ther apy in Pa tients LIv ing with Sys tolic Hy per ten sion), de signed to as sess the safety and 

ef fi cacy of Lotrel, com pared with a fixed oral com bi na tion of benazepril plus hy dro chlo ro thi a zide (HCTZ) 

in more than 11,000 pa tients with high-risk hy per ten sion. Lotrel sig nif i cantly de creased the risk of car - 

dio vas cu lar events by 20% com pared with benazepril plus HCTZ. Ap prox i mately twice the num ber of pa - 

tients tak ing ei ther of the fixed com bi na tions achieved tar get blood pres sure lev els com pared with their 

pre vi ous sin gle agent or com bi na tion ther a pies. At study en try, ap prox i mately 37% of pa tients were at 

the sys tolic blood pres sure tar get of less than 140 mmHg; af ter switch ing to a fixed com bi na tion and fol - 

low ing dose ti tra tion, 75% of pa tients given Lotrel and 72% given benazepril plus HCTZ achieved blood 

pres sure tar gets, and the mean sys tolic blood pres sure was ap prox i mately 130 mmHg. Both fixed com bi - 

na tions were well tol er ated, with a low in ci dence of ad verse events lead ing to dis con tinu a tion from the 

trial (ap prox i mately 15% in both treat ment arms). Hypotension oc cur ring as a se ri ous ad verse event was 

re ported in 0.4% of pa tients given Lotrel and in 0.5% given benazepril plus HCTZ. Approximately 70 of 

patients were continuing to take combination therapy at study closure. 



Lifecycle Man age ment: Novartis has con ducted the AC COM PLISH trial pro gram to gain ap proval for 

Lotrel in high-risk hy per ten sion pa tients. A fil ing is es ti mated for some time after 2009. 

Com pe ti tion: Ac cord ing to IMS, Lotrel was no lon ger the leader in the ‘ACE in hib i tors, Com bi na tions’ 

class in the 12-month pe riod to the end of Sep tem ber 2008, hav ing been dis placed by the Teva ge neric 

prod uct, Amlodip/Benaz Teva, with a 16.1% mar ket share and 110% fixed rate dol lar growth. In sec - 

ond place was Servier’s Bipreterax (indapamide + perindopril), with a 12.6% mar ket share and 16% 

fixed rate dol lar growth. Lotrel was num ber three, with an 11.4% mar ket share, but sales down 67% in 

fixed rate dol lar terms. Num ber four was Novartis’ own ge neric ver sion of Lotrel, Amlodip/Benaz Novt, 

with a 7.1% mar ket share and 260% fixed rate dollar growth. 

Sales/An a lyst Com ment: Lotrel was Novartis’ num ber 17 phar ma ceu ti cal prod uct in 2008 with sales 

of $386 mil lion, down 48%, due to ge neric com pe ti tion. Novartis noted that sales in 2008 came from 

higher-dose for mu la tions that still have mar ket ex clu siv ity. Mor gan Stan ley an a lysts (Jan u ary 2009) an - 

tic i pate 2009 sales down to $182 mil lion ($67 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore - 

cast sales of $375 mil lion in 2008 ($50 million by 2013). 

NITRODERM TTS/TRANSDERM-NI TRO (ni tro glyc er ine), a trans derm al patch in di cated in the pre - 

ven tion of an gina pectoris, was first launched in 1982. It is now avail able in sev eral coun tries world wide, 

in clud ing Ja pan. It uses ALZA’s (USA) patch de liv ery technology. 

TEKTURNA/RASILEZ (aliskiren), a renin in hib i tor, was first launched in the USA in March 2007 for the 

treat ment of high blood pres sure as monotherapy or in com bi na tion with other high blood pres sure med i - 

ca tions. In the USA, it is mar keted as Tekturna. In other mar kets it is called Rasilez. It was ap proved in 

all 27 EU mem ber states in Au gust 2007. It has since been launched in a num ber of Eu ro pean mar kets, 

plus Can ada, Spain, Nor way, Brazil, Mex ico and the Phil ip pines. Rasilez was filed for ap proval in Japan in 

February 2008. 

Tekturna is the first in a new class of antihypertensives called di rect renin in hib i tors. A once-daily oral tab - 

let ther apy, the drug acts by tar get ing renin, an en zyme re spon si ble for trig ger ing a pro cess that can con - 

trib ute to high blood pres sure. The prod uct has po ten tial for use in monotherapy as well as in com bi na tion 

with Diovan to give synergistic effect. 

Li cens ing: Novartis li censed aliskiren to Speedel (Swit zer land) in 2000 in a deal whereby it had an op tion 

to re ac quire rights upon com ple tion of phase II tri als by Speedel. Novartis ex er cised this op tion in 2002, 

and Speedel is now en ti tled to pay ments and roy al ties. Novartis paid a de vel op ment mile stone in 

mid-2004 in cor po rat ing a cash el e ment as well as an eq uity par tic i pa tion. In July 2008, Novartis be came 

the ma jor ity owner of Speedel, fol low ing the ac qui si tion of an ad di tional 51.7% stake in the com pany. A 

man da tory pub lic ten der of fer be gan in Au gust 2008 to buy the re main ing shares in Speedel. Novartis 

states that to tal ac qui si tion costs are es ti mated at around $880 mil lion. Novartis states that Speedel’s 

R&D pipe line is a strong fit with its leading position in cardiovascular disease. 

Clin i cal Data: In Oc to ber 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, pla cebo-con trolled, par - 

al lel group, phase III trial (AL TI TUDE) in the USA, Ar gen tina, Aus tria, Bel gium, Brazil, China and Thai land 

to de ter mine whether, in 8600 pa tients with type II di a be tes at high risk for car dio vas cu lar and re nal 

events, aliskiren, on top of con ven tional treat ment, re duces car dio vas cu lar and re nal mor bid ity and mor - 

tal ity. Pri mary out come mea sures will in clude car dio vas cu lar death, re sus ci tated sud den death, non-fa tal 

myo car dial in farc tion and non-fa tal stroke. Sec ond ary out come mea sures will in clude time from ran dom - 

iza tion to the first event of the fol low ing car dio vas cu lar end points: car dio vas cu lar death, re sus ci tated 

sud den death, non-fa tal myo car dial in farc tion, non-fa tal stroke and un planned hospitalization for heart 

failure. The trial is expected to complete in January 2012. 



In 2007, ini tial re sults of tri als re lated to the AS PIRE HIGHER pro gram showed po ten tial ben e fits of 

Tekturna/Rasilez in re duc ing a key biomarker of kid ney dis ease (AVOID) and in re duc ing the se ver ity of 

heart failure (ALOFT). 

In June 2008, data from the AVOID study were pub lished in the NEJM, dem on strat ing that aliskiren may 

have po ten tial kid ney-pro tec tive ben e fits that are in de pend ent of its al ready proven abil ity to pro vide 

pow er ful blood pres sure reductions. 

Also, in June 2008, Novartis an nounced de tails of two long-term out come stud ies of aliskiren as part of its 

AS PIRE HIGHER clin i cal trial pro gram. The two new stud ies will eval u ate the or gan pro tec tion po ten tial of 

aliskiren for the treat ment of heart fail ure and pre ven tion of car dio vas cu lar dis ease in the el derly. As part 

of the AS PIRE HIGHER clin i cal trial pro gram, aliskiren is be ing eval u ated in three ma jor out come stud ies. 

The AL TI TUDE study, be ing con ducted in pa tients with type II di a be tes at high risk from car dio vas cu lar 

and re nal events, will in ves ti gate whether aliskiren in com bi na tion with con ven tional ther apy de lays heart 

and kid ney com pli ca tions. The AT MO SPHERE study aims to de ter mine the ef fects of aliskiren, in ad di tion 

to stan dard ther apy, on mor bid ity and mor tal ity in acute and chronic con ges tive heart fail ure pa tients. 

The APOLLO study will as sess aliskiren’s abil ity to pre vent car dio vas cu lar mor bid ity and mor tal ity in el - 

derly pa tients with or with out hy per ten sion or other risk fac tors. Over all, the AS PIRE HIGHER clin i cal trial 

pro gram com prises 14 tri als in volv ing more than 35 000 pa tients. Short-to-me dium term stud ies be ing 

car ried out as part of the pro gram will eval u ate the or gan pro tec tion ben e fits of aliskiren in cardio-re nal 

con di tions in clud ing heart fail ure, post-acute cor o nary syndromes, post-myocardial infarction, left 

ventricular hypertrophy, coronary artery disease and diabetic nephropathy. 

Lifecycle Man age ment: Novartis has de vel oped a fixed com bi na tion prod uct, Tekturna HCT com pris - 

ing aliskiren and the di uretic, hy dro chlo ro thi a zide, for the treat ment of hy per ten sion. It was launched in 

the USA in Feb ru ary 2008. It has been ap proved in Swit zer land and rec om mended for ap proval in Eu - 

rope. In Eu rope, it will be known as Rasilez HCT. 

Novartis is also de vel op ing a fixed dose com bi na tion of Diovan (valsartan) and aliskiren and this was 

filed for ap proval in the USA in 2008 and Novartis an tic i pates an ap proval in 2009. Phase III tri als have 

been con ducted in the USA, Can ada and Ger many for the treat ment of hypertension. 

Com pe ti tion: Speedel’s (now Novartis) new renin in hib i tor, SPP 635, is in phase II tri als. Speedel is 

also study ing other renin in hib i tors and has two in phase I tri als, SPP 1148 and SPP 676. Actelion (Swit - 

zer land) is also study ing renin in hib i tors, and in 2003 formed an al li ance with Merck &Co to work on 

these; their lead prod uct MK 8141 is in phase II tri als. GlaxoSmithKline has an al li ance with Vi tae 

Pharmaceuticals to de velop renin in hib i tors. Many com pa nies have tried and failed to pro duce renin in hib - 

i tors. It has been dif fi cult to find an ef fec tive mol e cule that can be given in once-daily tablets. 

Sales/An a lyst Com ment: Tekturna sales in 2008 were $144 mil lion. Ac cord ing to Novartis, it has per - 

formed well in a highly com pet i tive US mar ket place. Key driv ers have been broad clin i cal data dem on - 

strat ing ef fi cacy in low er ing blood pres sure, its safety pro file and ris ing re im burse ment rates in US 

for mu lary plans. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast sales of $291 mil lion in 2009 ($493 

mil lion by 2012 and $532 mil lion by 2014, in clud ing com bi na tions, such as the fixed dose combination 

with valsartan). 

TEKTURNA HCT (aliskiren + hy dro chlo ro thi a zide), a fixed com bi na tion prod uct com pris ing the renin in - 

hib i tor Tekturna (aliskiren) and the di uretic hy dro chlo ro thi a zide, for the treat ment of hy per ten sion, was 

launched in the USA in Feb ru ary 2008. Ap proval was based on data from seven clin i cal tri als of aliskiren 

alone and in com bi na tion with hy dro chlo ro thi a zide that in volved more than 6,200 pa tients. Sub mis sions 

were made for four dif fer ent dos age com bi na tions of aliskiren and hy dro chlo ro thi a zide: 150/12.5mg tab - 

lets, 150/25mg tab lets, 300/12.5mg tab lets and 300/25mg tab lets. This com bi na tion was ap proved in 



Swit zer land in Oc to ber 2008. In No vem ber 2008, it was rec om mended for ap proval in Eu rope, with a de - 

ci sion by the Eu ro pean au thor i ties ex pected in early 2009. In Eu rope, it will be known as Rasilez HCT. 

Clin i cal Data: In May 2008, Novartis re ported re sults from an eight-week study of Tekturna HCT in pa - 

tients with high blood pres sure not ad e quately con trolled by hy dro chlo ro thi a zide alone. Pa tients re ceived 

hy dro chlo ro thi a zide alone, or hy dro chlo ro thi a zide 25 mg with aliskiren 300 or 150 mg. The ef fect of ther - 

apy on di a stolic and sys tolic blood pres sure was mea sured. Hy dro chlo ro thi a zide 25 mg with aliskiren 300 

or 150 mg re duced sys tolic and di a stolic blood pres sure by 16.7/10.7 mmHg and 12.9/8.5 mmHg, re - 

spec tively, com pared with 7.1/4.8 mmHg for hy dro chlo ro thi a zide alone (p less than 0.001). Tekturna 

HCT was well tol er ated; fewer cases of hypokalemia were ob served for Tekturna HCT than 

hydrochlorothiazide alone. 

Central Nervous System Agents 

COMTAN (entacapone), a catechol-O-methyltransferase (COMT) in hib i tor used in the treat ment of Par - 

kin son’s dis ease, de vel oped by Orion (Fin land), was ap proved in the EU in 1998. Launches then took 

place in Eu rope, through Orion or li censee Novartis. Out side Eu rope, in 1999, Novartis launched it in the 

USA, and has since launched the prod uct in var i ous world wide mar kets. Entacapone was filed in Ja pan in 

2005 and launched in April 2007. An entacapone-based com bi na tion drug Stalevo (levodopa + 

carbidopa + entacapone) was first launched in the USA in 2003. 

Li cens ing: Orion li censed entacapone out to Novartis in 1996. Orion re tains mar ket ing ex clu siv ity in 

Scan di na via, the Bal tic States, Ger many, the UK and Ire land and mar kets it as Comtess. Novartis has 

rights else where in the world as Comtan. Un der the terms of the deal, Novartis agreed to make an 

up-front pay ment of $4.8 mil lion and un dis closed milestone payments. 

Pat ents: In Au gust 2007, an un iden ti fied com pany filed an ANDA with the FDA for a ge neric ver sion of 

Comtan. The ap pli cant has cer ti fied with the FDA that it would not seek ap proval to mar ket ge neric 

entacapone be fore the ex piry of Orion’s pat ents, the lat est of which was due to ex pire on May 12, 2009. 

In Sep tem ber 2007, Orion filed a pat ent in fringe ment law suit in the USA against generics com pany 

Wockhardt (In dia). In 2008, IMS Pat ents Fo cus re ported that the US pat ent had been extended to 2013. 

Clin i cal Data: Comtan be longs to a class of drugs called COMT in hib i tors that can en hance the ef fec tive - 

ness of levodopa, a ge neric drug of ten used to treat Par kin son’s dis ease. Comtan blocks the break down of 

levodopa be fore it reaches the brain, and there fore use of Comtan means that pa tients can take less 

levodopa. Three stud ies in North Amer ica, Scan di na via and Ger many showed that Comtan helped im - 

prove mo tor func tion in pa tients with a de te ri o rat ing re sponse to levodopa, par tic u larly in ar eas such as 

speech, hand writ ing, walk ing and dress ing. Orion an tic i pates that entacapone will be use ful in im prov ing 

the fail ing ther a peu tic re sponse of Par kin son’s dis ease pa tients. It may be ad min is tered con cur rently with 

Merck & Co’s Sinemet (carbidopa + levodopa) and Roche’s Madopar (benserazide + levodopa). In 

1998, the Eu ro pean CPMP de cided that Comtan did not ap pear to cause sig nif i cant liver tox ic ity, though 

there had been some rare re ports of in creases in liver en zymes. The de ci sion came af ter the Eu ro pean 

with drawal of a sim i lar drug, Roche’s Tasmar (tolcapone), due to se vere hepatotoxicity. Warn ing let ters 

about the risk of rhabdomyolysis and neuroleptic ma lig nant syn drome have been sent out in a num ber of 

Eu ro pean coun tries by Orion. US la bel ing for Comtan does not men tion any pos si bil ity of liver in jury or of 

liver enzyme elevations with use of entacapone, nor is a possible COMT inhibitor class effect presumed. 

Lifecycle Man age ment: Orion has de vel oped a com bi na tion prod uct Stalevo (entacapone + levodopa 

+ carbidopa), which it also mar kets in part ner ship with Novartis. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Boehringer Ingelheim’s Sifrol 

(pramipexole) was the lead ing prod uct in the global Anti-Par kin son Drugs class (N4A), ac cord ing to IMS, 

with a 26.5% mar ket share and 25% fixed rate dol lar growth. Num ber two was GlaxoSmithKline’s 



Requip (ropinirole), with a 15.9% mar ket share but sales down 2% in fixed rate dol lar terms. Requip and 

Sifrol have also been ap proved for use in rest less leg syn drome (RLS). Num ber three was Novartis’ 

Stalevo, with a 10.2% mar ket share and 22% fixed rate dol lar growth. Roche’s Madopar was num ber 

four, with a 6.1% mar ket share and 3% fixed rate dol lar growth. Comtan was num ber five with a 4.2% 

mar ket share, up 10%. Teva’s Azilect (rasagiline), first launched in 2005, was in sev enth po si tion, with a 

3.8% mar ket share and 49% fixed rate dol lar growth. UCB’s Neupro (rotigotine), first launched in 2006, 

is also grow ing rap idly. It was the num ber nine prod uct in this class, with a 2.6% mar ket share, but 128% 

fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, the Comtan/Stalevo group of prod ucts was Novartis’ num ber 12 

prod uct group, with com bined sales of $502 mil lion, up 15% in lo cal cur rency terms. Mor gan Stan ley an - 

a lysts (Jan u ary 2009) fore cast sales of $532 mil lion in 2009 (peak ing at $672 mil lion by 2013 and fall ing 

to $336 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $515 in 2008 (peak ing at 

$750 mil lion in 2012 and fall ing to $350 million by 2013). 

EXELON (rivastigmine), an acetylcholinesterase in hib i tor, was launched in Swit zer land, its first world 

mar ket, in 1997 for the treat ment of Alz hei mer’s dis ease and ischemia-in duced ce re bral dis or ders. It has 

now been ap proved in al most 70 coun tries (but not Ja pan). It was launched in China in 2001. It was 

launched in the USA and Can ada in 2000 for the symp tom atic treat ment of mild-to-mod er ate Alz hei mer’s 

dis ease. Novartis claims that Exelon is the first Alz hei mer’s dis ease ther apy to show clin i cal ben e fits for 

key do mains used to as sess the dis ease, i.e. global func tion ing (in clud ing ac tiv i ties of daily liv ing, and be - 

hav ior), and cog ni tion. In 2006, Exelon was also ap proved and launched in a num ber of mar kets, in clud - 

ing the UK and the USA for the treat ment of mild-to-mod er ately se vere dementia associated with 

idiopathic Parkinson’s disease. 

Novartis has de vel oped a trans derm al patch for mu la tion of rivastigmine, Exelon Patch. In July 2007, it 

was ap proved in the USA for the treat ment of mild-to-mod er ate Alz hei mer’s dis ease and mild-to-mod er - 

ate de men tia as so ci ated with Par kin son’s dis ease. The fil ing was based on data from a phase III trial, des - 

ig nated IDEAL (In ves ti ga tion of Exelon Patch in Alz hei mer’s dis ease), in nearly 2,000 pa tients with 

mod er ate Alz hei mer’s dis ease. Exelon Patch had sim i lar ef fi cacy to rivastigmine cap sules, and was well 

tol er ated at the rec om mended dose of 9mg/day, with three times fewer re ports of nau sea or vom it ing. It 

was launched in the USA in Q4 2007. The prod uct was ap proved in Eu rope in Sep tem ber 2007 and 

launched in the UK in Oc to ber 2007. The patch was launched in South Ko rea in 2008. Phase III trials with 

Exelon Patch are ongoing in Japan. 

Li cens ing: In 2005, Novartis and Ono (Ja pan) agreed to co-de velop and co-mar ket the rivastigmine 

trans derm al patch in Ja pan. It is been de vel oped in Ja pan as ENA 713D. Rivastigmine was li censed-out 

to Esteve for co-mar ket ing in Spain in 1999 by Novartis. Exteva co-mar kets it in Spain as Prometax. 

Pat ents: Novartis granted Wat son (USA) a li cense for au tho rized ge neric ver sion of Exelon in De cem ber 

2007. The agree ment pro vides that Wat son will not com mence mar ket ing its ge neric prod uct un til some - 

time prior to the ex pi ra tion of the pat ents cov er ing Exelon. The spe cific date on which Wat son may launch 

its prod uct has not been dis closed. Wat son has re ceived ten ta tive ap proval from the FDA for ge neric 

Exelon. The Jap a nese pat ent on rivastigmine ex pired in March 2008. In most of Eu rope, the com pound is 

re ported to be pro tected by sup ple men tary pro tec tion cer tif i cates run ning un til 2012. In the USA, the 

pat ent ex pires in Feb ru ary 2014. In Jan u ary 2008, it was re ported that Dr Reddy’s (In dia) had en tered 

into a set tle ment agree ment with Novartis, which in volved a stip u la tion of dis missal of US law suits re lat - 

ing to Dr Reddy’s ANDA for a ge neric ver sion of rivastigmine. Un der the terms of the deal, Dr Reddy’s will 

not launch its ge neric prod uct un til some time be fore the ex piry of the Or ange Book pat ents claim ing 

rivastigmine. Dr Reddy’s re ceived final approval from the US FDA in October 2007 for its rivastigmine 

capsules. 



Lifecycle Man age ment: Novartis is study ing Exelon in com bi na tion with For est’s (USA) Namenda 

(memantine) for Alz hei mer’s dis ease. En roll ment for an open-la bel, 26-week, sin gle-arm study in 150 

pa tients with prob a ble Alz hei mer’s dis ease started in 2006. 

Com pe ti tion: Exelon’s main com pet i tor is Pfizer/Eisai’s Aricept (donepezil), the first prod uct of this 

type to reach the mar ket. Aricept and Exelon have sim i lar ef fi cacy, but Aricept is dosed once per day, 

whilst Exelon has twice-daily dos ing, and un like Aricept it should be taken with food. Exelon la bel ing also 

notes sig nif i cant GI ad verse re ac tions, in clud ing nau sea and vom it ing, an orexia and weight loss. An other 

AchE in hib i tor, John son & John son’s Reminyl (galantamine) was first launched in the UK in 2000 and 

was launched in the USA in 2001. It is now avail able in a number of markets. 

In 2003, the FDA ap proved For est’s NMDA an tag o nist Namenda (memantine), which is now in creas ing 

its mar ket share in this sec tor. Memantine was orig i nally de vel oped by Merz (Ger many) for the treat ment 

of de men tia, Alz hei mer’s dis ease and spasticity. It was first mar keted in Ger many in 1982, but was first 

pat ented for use in treat ing Alz hei mer’s dis ease in 1989, and has since then been suc cess fully de vel oped 

for this in di ca tion by Merz. It has been li censed-out to Lundbeck (Den mark) for world mar kets out side the 

USA and Ja pan and to For est for the USA. It is li censed to Daiichi Suntory (Ja pan) for Ja pan, where it is in 

clin i cal tri als. Gruenenthal also has non-exclusive rights in Spain and Portugal. 

Ac cord ing to IMS, Exelon was the world’s num ber three Anti-Alz hei mer prod uct (class N7D) in the 

12-month pe riod to the end of Sep tem ber 2008, with an 11.6% mar ket share, and 22% fixed rate dol lar 

growth. Aricept led the class with a 53.1% mar ket share and 16% fixed rate dol lar growth. Num ber two 

was For est’s Namenda, with a 14.4% mar ket share, and 18% fixed rate dol lar growth. J&J’s Reminyl was 

num ber four with a 9.9% mar ket share and 5% fixed rate dol lar growth. Ebixa, the IMS in ter na tional 

phar ma ceu ti cal prod uct name for memantine sold by Lundbeck, was num ber five, with a 5.9% mar ket 

share and 16% fixed rate dol lar growth. Axura, the name for memantine sold by Merz, was num ber six 

with a 2.3% mar ket share and 13% fixed rate dollar growth. 

Sales/An a lyst Com ment: Exelon/Exelon Patch sales in 2008 were $815 mil lion, up 24% in lo cal cur - 

rency terms, and it was Novartis’ num ber eight phar ma ceu ti cal prod uct. Novartis notes that this fran - 

chise has been re vived by the launch of the Exelon patch, which has quickly gained ac cep tance with 

pa tients. Sales in the USA grew 32% to $279 mil lion, and 20% in the rest of the world to $536 mil lion. 

Mor gan Stan ley an a lysts (Jan u ary 2009) pre dict sales of $841 mil lion in 2009 (peak ing at $936 mil lion in 

2011 and fall ing to $479 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $790 mil - 

lion in 2008 ($975 mil lion by 2011 and $800 mil lion by 2013). Ac cord ing to IMS, in the 12 month pe riod to 

the end of Sep tem ber 2008 Exelon was Novartis’ num ber nine in ter na tional prod uct ac count ing for a 

2.1% share of revenue with 22% fixed rate dollar growth. 

FOCALIN/FOCALIN XR/ATTENADE (dexmethylphenidate), Celgene’s (USA) long-act ing for mu la tion 

of the al pha adrenergic ag o nist methylphenidate, was launched in the USA, its first world mar ket, in 2002 

by Novartis. It was de vel oped to elim i nate the need for sub jects with at ten tion def i cit dis or der to self-ad - 

min is ter a mid-day dose. This is a fol low-up prod uct to (and chirally pure ver sion con tain ing the ac tive 

iso mer of) Novartis’ Ritalin. In No vem ber 2008 the US FDA ap proved for in clu sion on its la bel ing of a 30 

min ute onset of action for Focalin XR. 

Li cens ing: In 2000, Focalin was li censed to Novartis by Celgene. Novartis made a mile stone pay ment of 

$10 mil lion to Celgene and a joint Celgene-Novartis com mit tee was formed for the de vel op ment and 

com mer cial iza tion of Focalin world wide, out side Can ada (where Biovail has rights). Novartis agreed to 

fund all re main ing de vel op ment costs to com plete phase III tri als in the USA and Can ada. The deal also 

cov ers all re lated in tel lec tual prop erty rights and pat ents, in clud ing new for mu la tions of Novartis’ cur - 

rently mar keted methylphenidate prod uct Ritalin (in clud ing Ritalin LA). Celgene will re ceive upfront 

fees, mile stone pay ments, and roy al ties on all for mu la tions of dexmethylphenidate (a chirally pure ver - 



sion of Ritalin) and Novartis will pro vide funds for all fur ther development, and regulatory and marketing 

costs. 

Clin i cal Data: A head-to-head study, pub lished in the June 2008 Jour nal of Child and Ad o les cent 

Psychopharmacology, con firmed that Focalin XR ex tended re lease cap sules of fer greater im prove ments 

in man ag ing ADHD symp toms com pared with Concerta ex tended-re lease tab lets at two hour post-dose, 

the pri mary study endpoint. 

Pat ents: The FDA granted fi nal ap proval for Teva’s (Is rael) ge neric ver sion of Focalin in early 2007. 

Novartis and Celgene have filed pat ent in fringe ment suits so launch by Teva is un cer tain. If Teva 

launches and is later found to have will fully in fringed, it could be held li a ble for dam ages. Barr (USA) has 

also filed for a ge neric Focalin XR with the FDA. 

Lifecycle Man age ment: Novartis has de vel oped an ex tended re lease dexmethylphenidate (Focalin 

XR), ap proved by the FDA in 2005 and launched sub se quently. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Focalin was the 

num ber four prod uct in the ‘Psychostimulants’ class (N6B), with a 6.2% mar ket share and 19% fixed rate 

dol lar growth. The lead ing prod uct was Shire’s Adderall (am phet amine + dex am pheta mine), with a 

27.3% mar ket share and 9% fixed rate dol lar growth. Num ber two was J&J’s Concerta 

(methylphenidate), with a 25.7% mar ket share and 6% dol lar growth. Num ber three was Cephalon’s 

Provigil (modafinil), with an 18.5% mar ket share and 9% dol lar growth. In fifth place was Shire’s 

Vyvanse (lisdexamfetamine), with a 6.1% mar ket share and 595% growth. Novartis’s Ritalin 

(methylphenidate) was num ber six, with a 4.0% mar ket share and 1% fixed rate dollar growth. 

Lilly’s noradrenaline reuptake in hib i tor, Strattera (atomoxetine), first launched in the USA in 2003, is 

the only ADHD treat ment not con trolled as a stim u lant un der the US Con trolled Sub stances Act and will 

be avail able for use once or twice daily. Strattera is clas si fied by IMS as be long ing to the N7X class (all 

other CNS drugs), where it was ranked as the lead ing prod uct. Other com pet i tors in de vel op ment in 2008 

for ADHD in clude Addrenex/Sciele’s Clonicel (sus tained-re lease clonidine hy dro chlo ride) in phase III tri - 

als in com bi na tion with stim u lants, Targacept/AstraZeneca’s AZD 3480 in phase II tri als, and Saegis 

Pharmaceuticals’ (USA, now Lundbeck), SGS 742. 

Sales/An a lyst Com ment: In 2008, the Ritalin/Focalin group of prod ucts was Novartis’ num ber 14 

prod uct group with com bined sales of $440 mil lion, up 17%. Mor gan Stan ley an a lysts (Jan u ary 2009) 

fore cast sales will peak at $575 mil lion in 2013 and fall to $547 mil lion by 2014. Cowen & Co an a lysts (Au - 

gust 2008) fore cast sales of $415 mil lion in 2008 ($490 million by 2013). 

CLOZARIL/LEPONEX (clozapine), a neuroleptic for use in schizo phre nia, was first launched in Aus tria 

in 1972. It is now mar keted in most coun tries world wide, in clud ing the USA (launched in 1990). In 2002, 

the FDA ap proved the use of Clozaril for the treat ment of re cur rent sui cidal be hav ior in pa tients with 

schizo phre nia or schizoaffective dis or der who are at chronic risk. This was the first time that any med i ca - 

tion has been ap proved to treat sui cidal be hav ior. It has since been ap proved in other mar kets for this 

additional indication. 

In 2003, an FDA ad vi sory com mit tee rec om mended fur ther re duc ing the fre quency of man da tory WBC 

mon i tor ing for pa tients to ev ery month af ter they have been on Clozaril for one year. In the same year, 

the FDA re quested prod uct la bel ing on all atyp i cal antipsychotics to in clude a warn ing about ad di tional in - 

for ma tion on hyperglycemia and di a be tes. Al though not fully un der stood, ep i de mi o log i cal stud ies have 

sug gested some in creased risk. In 2004, the Amer i can Di a be tes So ci ety (among other groups) re opened 

the de bate sur round ing in creased obe sity and type 2 di a be tes in pa tients re ceiv ing atyp i cal 

antipsychotics, where Clozaril came off badly. Novartis wel comed the ADA’s rec om men da tion to mon i tor 

pa tients more closely, com ment ing that the la bel al ready con tains a di a be tes warn ing and that Clozaril is 



used as a last re sort treat ment due to dan ger ous SE agran u lo cy to sis. The FDA has added a warn ing of 

increased risk of hyperglycemia and diabetes with Clozaril and all atypical antipsychotics. 

In 2005, the FDA re quested that all man u fac tur ers of atyp i cal antipsychotic drugs, in clud ing Clozaril, add 

a boxed warn ing high light ing the in creased risk of death when these prod ucts are used off-la bel to treat 

be hav ioral dis or ders in el derly pa tients with dementia. 

Clin i cal Data: Clozaril has a risk of caus ing the po ten tially fa tal side ef fect of agran u lo cy to sis and blood 

mon i tor ing is re quired with use of the drug. How ever, Clozaril is re ported to have shown to have a sig nif i - 

cantly lower in ci dence of agran u lo cy to sis than first ex pected. A study showed that the av er age in ci dence 

was 0.38%, whilst 1-2% had been pre dicted. It was re ported by Swe den’s Ad verse Re ac tions Ad vi sory 

Com mit tee in 2000, that Clozaril may be linked to ve nous thromboembolism and, in 2002, Novartis 

alerted doc tors to a po ten tially fa tal heart con di tion, myocarditis, linked to use of the drug. 

Novartis has con ducted a trial com par ing the ef fects of Clozaril with Lilly’s Zyprexa (olanzapine) on the 

risk of sui cide and self-de struc tive be hav ior in pa tients with schizo phre nia and schizoaffective dis or der, 

the In ter na tional Sui cide Pre ven tion Trial (InterSePT). Re sults were pub lished in 2003 in the Ar chives of 

Gen eral Psy chi a try. The study found that Clozaril can re duce by up to 26%, the risk of re cur rent sui cidal 

be hav ior and sui cide at tempts among peo ple suf fer ing from schizo phre nia or schizoaffective dis or der. 

The study is the first ever to pro spec tively dem on strate ef fi cacy of a med i ca tion to affect suicidal behavior 

in any patient group. 

Ac cord ing to re sults of a 50-pa tient, 10-week trial, pub lished in Neu rol ogy in 2004, low-dose clozapine is 

ef fec tive in treat ing dyskinesias (in vol un tary move ments) re sult ing from long-term levodopa ther apy in 

pa tients with se vere Par kin son’s disease. 

Com pe ti tion: Clozaril is now sub ject to ge neric com pe ti tion in the USA, as its pat ent ex pired in 1995. It 

poses a chal lenge to ge neric man u fac tur ers, as any one wish ing to mar ket a ge neric ver sion would also 

have to ar range for a mon i tor ing sys tem to be used with it. How ever, Teva (Is rael) has launched a ge neric 

version of clozapine. 

In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, the num ber one prod uct in the 

antipsychotics cat e gory was AstraZeneca’s Seroquel (quetiapine), with a 23.2% mar ket share and 7% 

fixed rate dol lar growth. Num ber two was Lilly’s Zyprexa (olanzapine), with a 22.2% mar ket share, but 

sales down 2% in fixed rate dol lar terms. Num ber three was J&J’s Risperdal (risperidone), with a 19.8% 

mar ket share but sales down 10% in fixed rate dol lar terms. Num ber four was Otsuka’s Abilify 

(aripiprazole), with a 14.7% mar ket share and 27% fixed rate dol lar growth. Pfizer’s Zeldox 

(ziprasidone) was num ber five, with a 5.1% mar ket share and 16% fixed rate dol lar growth. J&J’s 

Invega (paliperidone) was num ber six, with a 1.4% mar ket share and 203% fixed rate dol lar growth. 

Teva’s ge neric risperidone prod uct, Risperidone Teva, was num ber seven, with a 1% mar ket share. 

Leponex (the of fi cial IMS in ter na tional prod uct name for Clozaril) was in eighth place, with a 1.0% mar - 

ket share, but sales down by 6% in fixed rate dol lar terms. Teva’s ge neric clozapine (Clozapine Teva) 

was at num ber ten, with a 0.3% mar ket share and 2% fixed rate dol lar growth. Teva also mar kets a ge - 

neric ver sion of olanzapine, which was in num ber 12 po si tion in this class in the pe riod, with a 0.3% 

market share but sales down 2%. 

RITALIN (methylphenidate), a mild psychostimulant in di cated in the treat ment of at ten tion def i cit/hy - 

per ac tiv ity dis or der (ADHD) in chil dren, first launched in 1954, and now avail able world wide. A sus tained 

re lease ver sion, Ritalin-SR, is avail able but it has only cap tured a small mar ket share; an a lysts say that 

al though ad ver tised as an 8-hour drug, it only ac tu ally works for around six hours (con ven tional Ritalin 

lasts for four hours). It is also ab sorbed more slowly, but not as ex ten sively as Ritalin. As a re sult, the SR 

ver sion has less pre dict able ab sorp tion in the body. An ex tended-re lease once-daily ver sion, Ritalin LA, 

was ap proved by the FDA in 2002. Ritalin prod uct la bel ing was changed in 1996 to in clude the fact that it 



has weak car ci no genic po ten tial. Ritalin is a stim u lant with prop er ties sim i lar to co caine and am phet - 

amines, and like co caine it in creases the level of do pa mine in the brain. This sim i lar ity of mechanism has 

led to debate about its addictive nature. 

Pat ents: Barr (USA) filed an ANDA con tain ing a para graph IV cer tif i ca tion for a ge neric Ritalin LA prod uct 

with the FDA in May 2007 and re ceived no ti fi ca tion of the ap pli ca tion’s ac cep tance for fil ing in Sep tem ber 

2007. Novartis and Celgene filed suit to pre vent Barr from pro ceed ing with the com mer cial iza tion of its 

product. 

Com pe ti tion: In 2002, Novartis launched a chirally pure ver sion of Ritalin, Focalin 

(dexmethylphenidate), which it li censed-in from Celgene (USA). This is a long-act ing for mu la tion of 

methylphenidate, which was de vel oped to elim i nate the need for sub jects with ADHD to self-ad min is ter a 

mid-day dose. Novartis has rights in mar kets outside Canada. 

There are now a num ber of ge neric methylphenidate prod ucts on the mar ket in com pe ti tion with Ritalin. 

Many com pa nies have aimed to pro duce long-act ing for mu la tions for ex tra con ve nience. This is es pe - 

cially im por tant with chil dren, as they may need to take med i ca tion at school, which means that su per vi - 

sion is needed. In 2000, John son & John son’s Concerta (methylphenidate) was launched as the first 

once-a-day treat ment for ADHD, effective for 12 hours. 

An other strong com pet i tor is Shire’s (UK) Adderall (mixed am phet amine salts). Shire also mar kets a 

once-daily ver sion, Adderall XR. In 2002, Eli Lilly’s (USA) se lec tive noradrenaline reuptake in hib i tor 

Strattera (atomoxetine) was ap proved by the FDA, as the first ADHD treat ment that is not a stim u lant 

un der the Con trolled Sub stances Act. Strattera was launched in the USA in 2003 and is now avail able in a 

num ber of mar kets. Strattera has the ad van tage in that, un like the methylphenidate and am phet - 

amine-based prod ucts, it is not a stim u lant and there fore does not need a con trolled sub stance des ig na - 

tion and thus re peat pre scrip tions will be eas ier to ob tain. It is a se lec tive norepinephrine re-up take 

in hib i tor, orig i nally de vel oped as an an ti de pres sant. Its spe cific mech a nism of ac tion in ADHD has not 

been elu ci dated. Strattera can be taken once or twice a day, and is not linked to in som nia. It is also ap - 

proved for use in adults with ADHD, and some an a lysts have pre dicted peak sales of up to $1.4 bil lion. In 

2005, how ever, Lilly had to add a bolded warning about liver injury to the Strattera label. 

In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Ritalin was the num ber six 

prod uct in the ‘Psychostimulants’ class (N6B), with a 4.0% mar ket share and 1% fixed rate dol lar growth. 

The lead ing prod uct was Shire’s Adderall (am phet amine + dex am pheta mine), with a 27.3% mar ket 

share and 9% fixed rate dol lar growth. Num ber two was J&J’s Concerta (methylphenidate), with a 

25.7% mar ket share and 6% dol lar growth. Num ber three was Cephalon’s Provigil (modafinil), with an 

18.5% mar ket share and 9% dol lar growth. Novartis’ Focalin was num ber four, with a 6.2% mar ket 

share and 19% fixed rate dol lar growth. In fifth place was Shire’s Vyvanse (lisdexamfetamine), with a 

6.1% mar ket share with 595% growth. 

Sales/An a lyst Com ment: In 2008, the Ritalin/Focalin group was Novartis’ num ber 14 phar ma ceu ti cal 


a lysts (Jan u ary 2009) fore cast sales will peak at $575 mil lion in 2013 and fall to $547 mil lion by 2014. 

Cowen & Co an a lysts (Au gust 2008) fore cast sales of $415 mil lion in 2008 ($490 million by 2013). 

STALEVO (entacapone + levodopa + carbidopa), Orion (Fin land) and Novartis’ com bi na tion drug for 

Par kin son’s dis ease, was first launched in the USA in 2003 by Novartis. In 2003, it was also launched by 

Orion in Fin land, Swe den, the UK, Ire land, Ger many, and Den mark. In 2004, Orion launched it in Nor way 

and Novartis launched it in Bel gium, Hun gary, Ar gen tina, Aus tria, Greece, Spain, Swit zer land, and Brazil. 

It has since been launched in many mar kets world wide, in clud ing Por tu gal, Mex ico, South Ko rea, Hong 

Kong, Is rael, Chile, Sin ga pore, Ven e zuela, Uru guay, It aly, Peru, South Af rica, Tai wan and Egypt. Stalevo 

was not con ceived as a re place ment for Comtan (entacapone), but is in di cated for pa tients with signs 



and symp toms of end-of-dose ‘wear ing off’; a study found that 55% of pa tients cited this as big gest 

treat ment chal lenge and 92% of phy si cians sur veyed said that it was a sig nif i cant con cern. Stalevo was 

the first new form of levodopa in more than a de cade. Re sults of stud ies have in di cated greater control of 

PD symptoms as well as more convenient dosing. 

Li cens ing: Un der the terms of a 2000 deal, Orion has re tained rights in Ger many, the UK, Ire land, the 

Nordic and Bal tic coun tries, and some other re gions, and has the pos si bil ity of co-pro mot ing the new tri - 

ple ther apy in the USA, France, Spain, and 10 other coun tries. Novartis has ex clu sive rights in the rest of 

the world (ex cept Ja pan). The deal in cludes an upfront pay ment of $15 mil lion, and mile stone pay ments 

at reg u la tory ap prov als. The US fil ing trig gered a $10 mil lion milestone payment to Orion. 

Pat ents: In De cem ber 2008 Orion filed a pat ent in fringe ment suit against Wockhardt (In dia) fol low ing 

the fil ing of an ANDA. An au to matic stay on ap proval of the ANDA of 30 months has now begun. 

Clin i cal Data: Novartis and Orion are in ves ti gat ing the use of Stalevo as a first line ther apy to de lay the 

on set of mo tor com pli ca tions. 

In April 2008, Novartis re ported re sults from a phase III trial, des ig nated FIRST STEP (Favorability of Im - 

me di ate-Re lease carbidopa + levodopa vs STalevo; Short-Term com par i son in Early Par kin son’s), de - 

signed to com pare levodopa/carbidopa with Stalevo in pa tients with early Par kin son’s dis ease in 53 

in ves ti ga tion cen ters in Can ada, the Czech Re pub lic, Is rael, It aly, Po land, Por tu gal, Tur key and the USA. 

Stalevo showed sta tis ti cally sig nif i cant im prove ment com pared with levodopa/carbidopa in the pri mary 

end point, which was the com bined Uni fied Par kin son’s Dis ease Rat ing Scale (UPDRS) part II-ac tiv i ties of 

daily liv ing (eat ing, bath ing, dress ing) and part III-mo tor scores (agil ity, ri gid ity, trem ors)(p=0.045). 

This pro spec tive, dou ble-blind, ran dom ized, par al lel group, fixed dose trial lasted 39 weeks and en rolled 

423 pa tients. Novartis plans to sub mit reg u la tory fil ings in 2008 for use of Stalevo in pa tients with early 

Par kin son’s dis ease who have not been treated with levodopa. These filings will be based on results from 

this phase III trial. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Boehringer Ingelheim’s Sifrol 

(pramipexole) was the lead ing prod uct in the global Anti-Par kin son Drugs class (N4A), ac cord ing to IMS, 

with a 26.5% mar ket share and 25% fixed rate dol lar growth. Num ber two was GlaxoSmithKline’s 

Requip (ropinirole), with a 15.9% mar ket share but sales down 2% in fixed rate dol lar terms. Requip and 

Sifrol have also been ap proved for use in rest less leg syn drome (RLS). Num ber three was Stalevo, with a 

10.2% mar ket share and 22% fixed rate dol lar growth. Roche’s Madopar was num ber four, with a 6.1% 

mar ket share and 3% fixed rate dol lar growth. Novartis’ Comtan was num ber five with a 4.2% mar ket 

share, up 10%. Teva’s Azilect (rasagiline), first launched in 2005, was in sev enth po si tion, with a 3.8% 

mar ket share and 49% fixed rate dol lar growth. UCB’s Neupro (rotigotine), first launched in 2006, is also 

grow ing rap idly. It was the num ber nine prod uct in this class, with a 2.6% mar ket share, but 128% fixed 

rate dollar growth. 

Sales/An a lyst Com ment: In 2008, the Comtan/Stalevo group of prod ucts was Novartis’ num ber 12 


a lysts (Jan u ary 2009) fore cast sales of $532 mil lion in 2009 (peak ing at $672 mil lion by 2013 and fall ing 

to $336 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $515 in 2008 (peak ing at 

$750 mil lion in 2012 and fall ing to $350 million by 2013). 

TEGRETOL (carbamazepine), an antiepileptic, was first launched in the UK in 1963. Tegretol is also 

avail able as a con trolled-re lease form as Tegretol CR/Tegretol Re tard and in sup pos i tory form. In 

1996, the con trolled-re lease form, which uses ALZA’s (USA) OROS sys tem, was ap proved in the USA as 

Tegretol XR. 



Com pe ti tion: Tegretol has lost ground to newer anti-ep i lep tics, in clud ing Novartis’ own Trileptal 

(oxcarbazepine), GSK’s Lamictal (lamotrigine), Pfizer’s Lyrica (pregabalin) and John son & John son’s 

Topamax (topiramate). In the 12-month pe riod to the end of Sep tem ber 2008, Tegretol was the eighth 

prod uct in the Anti-Ep i lep tics class (N3A), with a 2.5% mar ket share but zero fixed rate dol lar growth. 

Topamax led the mar ket, with a 16.2% mar ket share and 12% fixed rate dol lar growth, fol lowed by 

Lamictal, with a 14.8% mar ket share and 6% fixed rate dol lar growth. Lyrica was num ber three, with a 

14.8% mar ket share and 41% fixed rate dol lar growth. Num ber four was UCB’s Keppra (levetiracetam), 

with a 11.5% mar ket share and 38% fixed rate dol lar growth. Abbott’s Valcote (valproate semisodium) 

was num ber five, with a 10.4% mar ket share and 7% fixed rate dol lar growth. Trileptal was num ber six, 

with a 2.8% mar ket share, but sales down by 49% in fixed rate dol lar terms. Pfizer’s Neurontin 

(gabapentin) was num ber seven, with a 2.6% mar ket share but sales down by 17% in fixed rate dollar 

terms. 

Sales/An a lyst Com ment: Tegretol was Novartis’ num ber 13 prod uct in 2008 with sales of $451 mil - 

lion, up 6% in lo cal cur rency terms. Cowen & Co an a lysts (Au gust 2008) fore cast sales of $485 mil lion in 

2008 ($535 mil lion by 2013). 

TRILEPTAL (oxcarbazepine), an anticonvulsant in di cated in ep i lepsy, first launched in Den mark in 

1990, is now avail able in many mar kets world wide, in clud ing the USA, where it was launched in 2000. An 

oral sus pen sion for mu la tion is now avail able. It is suit able for use by adults and chil dren. Trileptal was li - 

censed-out to Kissei (Ja pan) for Ja pan in 1999, but Jap a nese de vel op ment was discontinued. 

In 2005, new warn ings and pre cau tions were added to the US la bel of Trileptal tab lets and oral sus pen - 

sion, de scrib ing se ri ous dermatological re ac tions, in clud ing Stevens-John son syn drome and toxic epi der - 

mal necrolysis. New pre cau tions cover cases of multi-or gan hy per sen si tiv ity reactions. 

Com pe ti tion: Ge neric oxcarbazepine was launched in the USA in Oc to ber 2007 by Caraco Lab o ra to ries, 

on be half of Sun Pharmaceuticals (In dia), af ter Sun re ceived ap proval from the FDA. Teva (Is rael) re - 

ceived FDA ap proval for its ge neric oxcarbazepine in December 2007. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, John son & John son’s Topamax 

(topiramate) was the num ber one prod uct in the Anti-Ep i lep tics class (N3A), with a 16.2% mar ket share 

and 12% fixed rate dol lar growth. GlaxoSmithKline’s Lamictal (lamotrigine) with a 14.8% mar ket share 

and 6% fixed rate dol lar growth, was in sec ond po si tion. Pfizer’s Lyrica (pregabalin) was num ber three, 

with a 14.8% mar ket share and 41% fixed rate dol lar growth. Num ber four was UCB’s Keppra 

(levetiracetam), with a 11.5% mar ket share and 38% fixed rate dol lar growth, fol lowed by Abbott’s 

Valcote (valproate semisodium) in fifth po si tion, with a 10.4% mar ket share and 7% fixed rate dol lar 

growth. Trileptal was num ber six, with a 2.8% mar ket share, but sales down by 49% in fixed rate dol lar 

terms. Pfizer’s Neurontin (gabapentin) was num ber seven, with a 2.6% mar ket share but sales down by 

17% in fixed rate dol lar terms. Novartis’ Tegretol (carbamazepine) was num ber eight, with a 2.5% mar - 

ket share and 0% fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, Trileptal was Novartis’ num ber 18 prod uct with sales of $332 mil - 

lion, down 53% in lo cal cur rency terms, due to ge neric com pe ti tion ($135 mil lion from US sales). Mor gan 

Stan ley an a lysts (Jan u ary 2009) fore cast sales of $236 mil lion in 2009 ($75 mil lion by 2013-14). Cowen 

& Co an a lysts (Au gust 2008) fore cast 2008 sales of $335 mil lion ($150 million by 2013). 

Dermatological Agents 

ELIDEL (pimecrolimus), a non-steroidal treat ment for ec zema and der ma ti tis, was first launched in the 

USA in 2002, and is now avail able in over 90 world mar kets in Eu rope, Latin Amer ica, East ern Eu rope, the 

Mid dle East and Australasia, plus Can ada. Pimecrolimus in hib its T cell and mast cell ac ti va tion and has 

po tent anti-in flam ma tory ac tiv ity. As it does not cause skin at ro phy, it could be suit able for fa cial use, and 



may play a role in the long-term dis ease man age ment. Novartis de scribed pimecrolimus as the first 

ascomycin macrolactam de riv a tive de vel oped for the treat ment of inflammatory skin diseases. 

In 2005, the FDA added a “black box” la bel to Elidel and an other pre scrip tion ec zema prod uct Protopic, 

warn ing that they might in crease the risk for cer tain can cers, es pe cially in chil dren. There is ev i dence that 

the prod ucts can cause can cer in mice and mon keys and there have been 13 re ports of skin can cer and 

lym phoma in chil dren and adults among us ers. How ever, Novartis has stated that there is no ev i dence 

that Elidel causes lym phoma and noted that the num ber of lym pho mas in ques tion “is be low the num ber 

typ i cally ob served in the gen eral pop u la tion.” The Amer i can Acad emy of Der ma tol ogy has also is sued a 

state ment crit i ciz ing the FDA decision for the same reasons. 

Li cens ing: In 2006, Conor Medsystems ob tained world wide, non-ex clu sive li cense to pimecrolimus for 

use with its next-gen er a tion con trolled vas cu lar drug de liv ery technologies. 

In 2004, Avantec Vas cu lar ob tained an op tion to li cense pimecrolimus for use in its drug-eluting stents. 

Pre clin i cal stud ies of the pimecrolimus-eluting stent in a por cine cor o nary model showed that the prod uct 

re duced intimal pro lif er a tion. 

Clin i cal Data: Data pub lished in 2004 sug gested that Elidel was safe and ef fec tive for use in in fants. 

Novartis has con ducted tri als in chil dren as young as three months and the orig i nal NDA re quested ap - 

proval for use in chil dren over three months of age. How ever, in 2001 the FDA ap proved the prod uct for 

use only in chil dren over two years of age. 

Com pe ti tion: Elidel’s main com pet i tor is Astellas’ Protopic (tacrolimus), an other new non-steroidal 

prod uct, first launched in Ja pan in 1999. Re sults of a head-to-head six-week study re vealed that Protopic 

was more ef fec tive at treat ing mod er ate-to-se vere ec zema than pimecrolimus. The trial in volved 193 

chil dren re ceiv ing ei ther tacrolimus 0.1% oint ment or pimecrolimus 1% cream and ex am ined at weeks 

one and three and at the end of the study. But data from three stud ies pre sented at the Amer i can Acad - 

emy of Der ma tol ogy meet ing in 2004, dem on strated that tacrolimus oint ment is more ef fec tive that 

pimecrolimus cream in the treat ment of adult and pe di at ric atopic der ma ti tis. In the sec ond half of 2004, 

Fujisawa pre sented a meta-anal y sis of re sults of three tri als in volv ing over 1,000 pa tients at the World 

Con gress of Pe di at ric Der ma tol ogy claim ing that tacrolimus is better than pimecrolimus at all lev els of se - 

ver ity of ec zema. Novartis has crit i cized these re sults as Protopic (0.1%), used in the study, is not ap - 

proved for pe di at ric use or for mild dis ease (whereas Elidel is not ap proved for se vere and very se vere 

pa tients); Astellas has not presented data for moderate patients where the two products overlap. 

Ac cord ing to IMS, Elidel led the D5X class (‘Other Nonsteroidal Prod ucts for In flam ma tory Skin Dis or - 

ders’) in the 12-month pe riod to the end of Sep tem ber 2008, with a 38.3% mar ket share, al though sales 

were down 17% in fixed rate dol lar terms. Protopic was num ber two with a 37.7% mar ket share and 12% 

fixed rate dol lar growth. Nycomed Pharma’s Solaraze (diclofenac) was num ber three, with a 13.8% 

mar ket share and 19% fixed rate dollar growth. 

Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast 2009 sales of $145 mil lion 

($112 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $155 mil lion in 2008 ($100 

mil lion by 2013). 

LAMISIL (terbinafine), an antifungal agent, was first launched in 1991 in the UK. It is now avail able in - 

ter na tion ally, in clud ing the USA and Ja pan. It is avail able in oral tab let and top i cal cream and spray for - 

mu la tions in most mar kets. Lamisil com bines a high level of ef fi cacy with rapid ac tion and a low re lapse 

rate. It is used in the treat ment of fun gal in fec tions of the skin and nails. It is highly ef fec tive in the treat - 

ment of fun gal nail in fec tions, and can clear up nail in fec tions in only three months, as op posed to six 

months with other drugs. It is also ef fec tive in the treat ment of ring worm, ath lete’s foot, jock itch, and 

other fungal infections. 



Pat ents: Lamisil’s pat ent in the UK, Ger many and It aly ex pired in 2005. US mar ket ing ex clu siv ity ex - 

pired in June 2007. 

Lifecycle Man age ment: In 1998, the FDA ap proved Lamisil DermaGel for the treat ment of tinea 

versicolor, tinea corporis and tinea pedis. It does not have an in di ca tion for tinea cruris like the cream for - 

mu la tion. In 1998, a spray for mu la tion was launched in Puerto Rico. In 1999, it was launched as an OTC 

treat ment, Lamisil AT Cream (1% terbinafine), for ath lete’s foot. Novartis said it was the first 

Rx-to-OTC switch prod uct for the con di tion in nearly ten years. Novartis claims that Lamisil AT works 

within one week, as op posed to four for ex ist ing treat ments. Lamisil AT was launched in the UK in 2001. 

Lamisil Spray Pump and So lu tion Drop per OTC for mu la tions were launched in 2000. 

In Sep tem ber 2007, the FDA granted mar ket ing ap proval for Novartis’ oral gran ule for mu la tion of Lamisil 

in the treat ment of tinea capitis in chil dren aged four years and older. The prod uct is ap proved for a 

once-daily, six-week reg i men. Novartis is also de vel op ing a nail lac quer for mu la tion in phase III tri als 

(NM 100060). 

Com pe ti tion: In 2007, var i ous com pa nies in clud ing Teva, Dr Reddy’s, Mylan and Barr launched ge neric 

terbinafine prod ucts in the USA. Novartis also launched its own terbinafine ge neric. Lamisil has al ready 

been ex posed to ge neric com pe ti tion in a large num ber of mar kets outside the USA. 

Ac cord ing to IMS, Lamisil was the num ber six prod uct in the J2A class (‘Sys temic Agents for Fun gal In fec - 

tions’) class in the 12-month pe riod to the end of Sep tem ber 2008, with a 6.1% mar ket share, but sales 

down 71% in fixed rate dol lar terms. Pfizer’s Vfend (voriconazole) was num ber one, with a 16.6% mar - 

ket share and sales up 11% in fixed rate dol lar terms. Merck & Co’s Cancidas (caspofungin) was num ber 

two, with a 12.4% mar ket share, but sales down 1%. Pfizer’s Diflucan (fluconazole) was num ber three, 

with an 8.4% mar ket share, but with sales down 21%. 

Sales/An a lyst Com ment: Lamisil had sales in 2007 of $595 mil lion, ac cord ing to Mor gan Stan ley an a - 

lysts (Jan u ary 2009), who put 2008 sales at around $266 mil lion. Sales are de clin ing due to ge neric com - 

pe ti tion. Mor gan Stan ley an a lysts fore cast sales of $202 mil lion in 2009 ($79 million by 2014). 

Genitourinary System/Sex Hormones 

ENABLEX/EMSELEX (darifenacin), a once-daily, ex tended-re lease se lec tive muscarinic M3 re cep tor 

an tag o nist for the treat ment of over ac tive blad der, was ap proved in the USA and in all 25 Eu ro pean 

mem ber states, plus Nor way and Ice land in 2004. It was first launched in 2005 in the USA as Enablex by 

Novartis. It was launched in Swe den, Den mark, Nor way and Swit zer land in 2005 by Novartis as Emselex 

and in Ger many as Emselex by li censee Bayer. It was also launched in Uru guay as Enablex in 2005. It has 

since been launched in a num ber of world mar kets. In Eu ro pean coun tries, it is mar keted as Emselex. In 

North Amer ica, Uru guay, Brazil, Co lom bia, Ar gen tina, Aus tra lia and South Af rica, it is mar keted as 

Enablex. In 2008, it was launched in Portugal and the Slovak Republic. 

Li cens ing: Darifenacin was orig i nally de vel oped by Pfizer, which filed for US ap proval in 2002. It was ac - 

quired by Novartis in 2003 for $225 mil lion. In 2004, Novartis granted Bayer ex clu sive Ger man com mer - 

cial iza tion and dis tri bu tion rights. In 2005, Novartis and Procter & Gam ble en tered into an agree ment for 

the co-pro mo tion and fur ther de vel op ment of Enablex in the USA. Novartis would con tinue to re cord rev - 

e nues for Enablex and would pay roy al ties to P&G based on the prod uct’s per for mance. In 2006, Ardana 

Bio sci ence (UK) gained rights to mar ket darifenacin in the UK. In 2007, Beijing Med-Pharm (China) 

signed an ex clu sive deal with Novartis to reg is ter, market and distribute Enablex in China. 

Clin i cal Data: In 2004, data was pre sented at the Amer i can Uro log i cal As so ci a tion meet ing from a 

439-pa tient study. Ad min is tra tion of 7.5mg and 15mg of darifenacin re duced the num ber of noc tur nal 

awak en ings by 22.1% and 22.7% re spec tively com pared with 3.6% in the pla cebo group af ter 12 weeks. 



This could be an im por tant in di ca tion as it in flu ences how the pa tients func tion in the day time. The same 

doses also pro duced a 68.7% and 76.5% re duc tion in weekly in con ti nence ep i sodes ver sus 46% for pla - 

cebo. Gen eral anticholinergic sys temic side ef fects (such as dry mouth, con sti pa tion, and blurred vi sion) 

have been noted with the drug despite its specificity for M3 muscarinic receptors. 

Com pe ti tion: Darifenacin’s main com pet i tors are the lead ing prod uct in this cat e gory, Pfizer’s 

Detrusitol (tolterodine) and a newer treat ment, Astellas’ M3 se lec tive prod uct Vesicare (solifenacin). 

Vesicare’s side ef fect pro file has dem on strated anticholinergic side ef fects (dry mouth/con sti pa tion), sim - 

i lar to the older OAB treat ments and its mar ket ing cam paign seems more fo cused now on price, with 

launch price at a dis count to older com pet i tors. Darifenacin, how ever, has shown lower lev els of these 

side ef fects but com pa ra ble ef fi cacy to im me di ate-re lease oxybutynin al though the study did not com - 

pare with the con trolled re lease ver sion. How ever, look ing at lat est IMS fig ures, sales of Vesicare are 

grow ing faster than sales of Enablex in fixed rate dollar terms. 

Ac cord ing to IMS, Enablex was the num ber three prod uct in the G4D class (Uri nary In con ti nence Prod - 

ucts) in the 12-month pe riod to the end of Sep tem ber 2008, with a 7.1% mar ket share and sales up 27% 

in fixed rate dol lar terms. Pfizer’s Detrusitol was num ber one prod uct, with a 41.7% mar ket share, up 

5% in fixed rate dol lar terms. Vesicare was sec ond, with a 21.3% mar ket share and sales up 53% in fixed 

rate dollar terms. 

Sales/An a lyst Com ments: Mor gan Stan ley an a lysts (Jan u ary 2009) put sales at $210 mil lion in 2008. 

They fore cast sales of $224 mil lion in 2009 ($288 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) 

fore cast sales of $205 mil lion in 2008 ($265 mil lion by 2013). 

ESTRADERM MX/ESTRADERM MA TRIX (17beta estradiol), a new ma trix form of the orig i nal 

Estraderm patch, was first launched in Swe den in 1995 for the treat ment of meno pausal symp toms and 

the pre ven tion of post-meno pausal os teo po ro sis. It has since been launched in a num ber of mar kets 

world wide. Estraderm MX is a sin gle layer patch, in which the ac tive in gre di ent, 17-beta estradiol, is con - 

tained within a ma trix in the ad he sive layer. This makes it thin ner and more flex i ble than 

Estraderm/Estraderm TTS (first launched in 1985), where the ac tive sub stance is mixed with eth a nol 

to form a gel con tained within a res er voir in the patch. How ever, un like the TTS patches, the MX does not 

re tain its efficacy if relocated during use. 

Li cens ing: In 2000, Kissei took over mar ket ing of Estraderm MX and Estraderm TTS in Ja pan). 

ESTRADOT/VIVELLE-DOT (drug de liv ery sys tem, trans derm al 17beta estradiol) is the world’s small - 

est trans derm al es tro gen de liv ery sys tem, in di cated for the treat ment of meno pausal symp toms. It was 

de vel oped by the women’s health joint ven ture of Novartis and Noven (USA), Novogyne Pharmaceuticals 

(for merly Vivelle Ven tures), and launched in the USA in 1999 as Vivelle-Dot. It has sub se quently gained 

EU ap proval and has been launched in a num ber of Eu ro pean coun tries, in clud ing Ger many, Bel gium, 

France, Ire land, the UK, Po land, Spain and Den mark as Vivelle-Dot or Estradot. Estradot has also been 

launched in Fin land, Nor way, Ven e zuela, Brazil, Ar gen tina, Aus tra lia, South Af rica and Uru guay. In 2002, 

the FDA ap proved the ex panded use of Vivelle-Dot for the pre ven tion of post-meno pausal os teo po ro sis. 

It was launched in Canada in 2001 as Estradot. 

Li cens ing: In 1998, Novartis and Noven formed a jv, Vivelle Ven tures, to mar ket Vivelle and Vivelle-Dot 

in North Amer ica (51%-owned by Novartis, and 49%-owned by Noven). Un der the jv agree ment, Noven 

was to man u fac ture the prod uct, pro mote it to phy si cians and re ceive roy al ties from the Vivelle Ven tures, 

and Novartis was to dis trib ute the prod uct. The com pa nies were to share prof its from Vivelle Ven tures. In 

1999, Noven an nounced that the Vivelle jv would change its name to Novogyne Pharmaceuticals with the 

launch of Vivelle-Dot. 



Hormonal Agents 

MIACALCIC/MIACALCIN (salcatonin), a syn thetic salmon calcitonin prep a ra tion for Paget’s dis ease, 

os teo po ro sis, and hypercalcemia, was first launched in 1976. Now avail able in many mar kets, it has 

proved par tic u larly pop u lar in It aly (calcitonin has tra di tion ally been widely used in South ern Eu rope). In 

1987, a na sal spray for mu la tion was launched. 

In April 2005, Miacalcic in di ca tions were up dated. Am poules and multidose vi als are now only in di cated 

for pre ven tion of acute bone loss due to sud den im mo bi li za tion such as in pa tients with re cent 

osteoporotic frac tures, Paget’s dis ease and hypercalcemia of ma lig nancy. Miacalcic na sal spray is in di - 

cated for the treat ment of es tab lished post-meno pausal os teo po ro sis in or der to re duce the risk of ver te - 

bral frac tures. Both for mu la tions are now con tra in di cated in patients with hypocalcaemia. 

Li cens ing: In 1999, Noven’s (USA) women’s health joint ven ture with Novartis, Novogyne 

Pharmaceuticals (pre vi ously known as Vivelle Ven tures LLC), agreed to co-pro mote Miacalcin na sal spray 

in the USA. 

Lifecycle Man age ment: In 2008, Novartis was de vel op ing an oral form of Miacalcic, with the labcode 

SMC 021, in phase III tri als for osteoarthritis and os teo po ro sis. It uses Emisphere’s (USA) Eligen drug 

de liv ery tech nol ogy. Novartis an tic i pates a fil ing for SMC 021 for the lead in di ca tion of osteoarthritis in 

2011. Novartis ac quired ex clu sive world wide rights from Emisphere to de velop and com mer cial ize oral 

calcitonin, us ing Emisphere’s pro pri etary Eligen drug de liv ery tech nol ogy in 2000. Novartis made a $10 

mil lion in vest ment in Emisphere, which is el i gi ble for mile stone pay ments up to $30 million and royalties 

on any sales. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Miacalcic was 

the num ber one prod uct in the ‘Cal ci tonins’ class (H4A), with a 40.5% mar ket share, but sales were down 

18% in fixed rate dol lar terms. Its clos est com pet i tor was Asahi Chem i cal’s Elcitonin (elcatonin), with a 

23.2% mar ket share but 0% fixed rate dol lar growth. Num ber three was Upsher Smith’s Fortical 

(salcatonin), with a 10.5% mar ket share and 23% growth in fixed rate dollar terms. 

Sales/An a lyst Com ment: Miacalcic sales were $281 mil lion in 2007, down 17%. Mor gan Stan ley an a - 

lysts (Jan u ary 2009) put sales at $253 mil lion in 2008 and fore cast sales of $232 mil lion in 2009 ($180 

mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales for the oral SMC 021 prod uct of 

$25 mil lion in 2012 ($50 million by 2013). 

OMNITROPE (somatropin), man u fac tured by re com bi nant DNA tech nol ogy, is a biogeneric/biosimilar 

prod uct to the hu man growth hor mone prod uct somatropin. It is pro duced in a 3.3mg/ml so lu tion for in - 

jec tion. It re ceived its first world wide ap proval in 2004 in Aus tra lia, and was launched in Aus tra lia in 2005. 

The in di ca tion is to treat growth dis tur bance in chil dren over three years of age and ad o les cents due to in - 

suf fi cient se cre tion of growth hor mone and growth dis tur bance as so ci ated with Turner syn drome or 

chronic re nal in suf fi ciency. It is also in di cated as a re place ment ther apy in adults with pro nounced growth 

hor mone de fi ciency. Omnitrope was the first biosimilar product to be approved in the EU and the USA. 

Omnitrope was ap proved in Eu rope and in the USA in 2006, af ter a lengthy cam paign in volv ing a le gal ac - 

tion against the FDA. In Eu rope, Novartis’ Sandoz di vi sion aimed to be first onto the mar ket in 2004 and 

had hoped to gain EU ap proval for Omnitrope be fore the end of 2003, fol low ing rec om men da tion by the 

CPMP in June 2003. How ever, in April 2004 it be came ap par ent that the Eu ro pean Com mis sion was, in a 

highly un usual step, re fus ing ap proval as it was un happy with the le gal path way of ‘well es tab lished use’ 

taken by Sandoz. Sandoz sub mit ted a sec ond ap pli ca tion in July 2004, based on a rec om men da tion from 

the EMEA and the Com mis sion. In Jan u ary 2005, the CHMP fi nally is sued a pos i tive opin ion re gard ing 

Omnitrope, pav ing the way for the launch of the first ge neric ri val to biotech med i cines in Eu rope. 

Omnitrope was fi nally ap proved in Jan u ary 2006 and was launched in Ger many in May 2006. In 2007, it 



was launched in the UK, Den mark, the Neth er lands, It aly, France, Spain, Fin land and Austria. It was 

launched in Bulgaria and Belgium in March 2008. 

In Sep tem ber 2008, the US FDA ap proved Sandoz’s sNDA for a new strength car tridge (10mg/1.5ml) of 

Omnitrope for use with a new re us able in jec tor pen, Omnitrope Pen 10. 

In the USA, Pfizer, the maker of a branded somatropin prod uct, Genotropin, lob bied against the ap - 

proval of Omnitrope and asked the FDA to de lay ap proval. The FDA in formed Novartis in 2004 that it has 

been un able to reach a de ci sion be cause of un cer tainty re gard ing sci en tific and le gal is sues. In 2005, 

Sandoz sued the FDA, seek ing to force it to make a de ci sion on its ap pli ca tion. The law suit, filed in a US 

Dis trict Court in Wash ing ton, al leged that the FDA vi o lated fed eral law by fail ing to make a fi nal rul ing, 

keep ing Omnitrope in “per pet ual limbo.” In May 2006, us ing a spe cial reg u la tion, the FDA au tho rized 

Omnitrope and cleared the way for it to com pete with Pfizer’s Genotropin in the USA. The spe cial reg u la - 

tion is known as 505(b)(2). The FDA ex pressly re jected the sug ges tion that the ap proval pro vided a 

far-reach ing pre ce dent for au tho riz ing fol low-on versions of other types of currently marketed products. 

Sandoz did not seek a ther a peu tic equiv a lence rat ing for Omnitrope. Con se quently, Omnitrope is not au - 

to mat i cally substitutable for Genotropin at the phar macy, al though in dus try ex perts said that a pre scrip - 

tion writ ten for somatropin could be filled with Omnitrope. 

Com pe ti tion: In the 12 month pe riod to the end of Sep tem ber 2008 Omnitrope was num ber nine in the 

‘To tal Growth Hor mones’ class, with a 1% mar ket share and 500% fixed rate dol lar growth, ac cord ing to 

IMS. Genotropin was num ber one, with a 29.8% mar ket share and 3% fixed rate dol lar growth. In sec ond 

place was Novo Nordisk’s Norditropin, with a 24.1% mar ket share and 9% fixed rate dol lar growth, fol - 

lowed in third place by Lilly’s Humatrope (somatropin) with a 16.8% mar ket share and 18% growth. 

SANDOSTATIN (octreotide), a somatostatin an a logue, first launched in 1988, is mainly used in the 

treat ment of gas tro in tes ti nal tu mors and acromegaly and avail able in most ma jor mar kets in clud ing the 

USA and Ja pan. Sandostatin LAR, a new long-act ing dos age form (once-monthly in jec tion for 

acromegaly), was launched in Ger many in 1997 and in the UK in 1998. In 1998, the FDA ap proved 

Sandostatin LAR, which is now sold in many mar kets world wide, including Japan. 

Pat ents: Pat ents have now ex pired and Sandostatin is open to ge neric com pe ti tion. 

Clin i cal Data: In Jan u ary 2009 Novartis re ported in terim data from a multicenter, pro spec tive, ran dom - 

ized, pla cebo-con trolled, dou ble-blind phase IIIb trial of Sandostatin LAR. The Ger man trial in cluded 85 

treat ment na ive pa tients with lo cally in op er a ble or met a static func tion ally ac tive neuroendocrine tu mors 

(NETs), with the pri mary tu mor in the midgut, who were with out cu ra tive ther a peu tic op tions. Fol low - 

ing six months of treat ment, Sandostatin LAR-treated pa tients had a 66% re duc tion in risk of dis ease 

pro gres sion, com pared with the pla cebo group; tu mor growth was halted in 69% and 39% of pa tients re - 

ceiv ing Sandostatin LAR and pla cebo, re spec tively. Sandostatin LAR-treated pa tients had no tu mor pro - 

gres sion for a me dian of 14.3 months, compared with six months for placebo-treated patients. 

Com pe ti tion: In 2005, Boehringer Ingelheim launched a ge neric ver sion of octreotide in the USA. In 

2006, Teva and Novartis launched ge neric octreotide prod ucts in the US. In the 12-month pe riod to the 

end of Sep tem ber 2008, Sandostatin was the lead ing prod uct in the H1C class (Hypothalmic Hor mones), 

with a 62.4% mar ket share and 4% fixed rate dol lar growth. The num ber two prod uct was Ipsen’s 

Somatuline (lanreotide), with an 8.8% mar ket share and 17% fixed rate dol lar growth. Num ber three 

was Pfizer’s Somavert (pegvisomant), with a 6.6% mar ket share and sales up 26% in fixed rate dol lar 

terms. Num ber four was Takeda’s Enantone (leuprorelin), with a 4.4% mar ket share and 1% fixed rate 


Ambrilia (Can ada) is car ry ing out phase III tri als with its pro pri etary pro longed-re lease for mu la tion of 

octreotide, which it re fers to as octreotide C2L (drug de liv ery sys tem, octreotide, Ambrilia in IMS 



R&D Fo cus). In Oc to ber 2008, it re ported pos i tive re sults from a sec ond phase III study which con firmed 

that octreotide C2L 30mg ev ery six weeks can re place Sandostatin LAR 30mg ev ery four weeks in 

acromegalic pa tients, with the same clin i cal ben e fit and no un ex pected or se ri ous ad verse ef fects. Dr 

Philippe Calais, Ambrilia’s pres i dent and CEO stated, “These new data fur ther val i date C2L’s po ten tial to 

be a safe, ef fec tive and cost ef fec tive ther apy, well po si tioned to cap ture a size able por tion of the $1 bil - 

lion plus Sandostatin LAR mar ket.” Ambrilia aims to license-out or sell octreotide C2L. 

Indevus (USA) is de vel op ing an octreotide ac e tate-con tain ing im plant, de vel oped us ing its pro pri etary 

HYDRON drug de liv ery plat form. The im plant is de signed to pro vide con tin u ous six-month ad min is tra tion 

of octreotide ac e tate for the treat ment of acromegaly. In Sep tem ber 2008, Indevus an nounced the ini ti a - 

tion of a ran dom ized, open-la bel US and Eu ro pean phase III trial to in ves ti gate the ef fi cacy, safety and 

tolerability of its octreotide im plant in pa tients with acromegaly. The trial will be con ducted at 34 clin i cal 

sites in six coun tries, and the planned en roll ment will be 140 pa tients known to be re spond ers to 

somatostatin an a logues, with well-main tained growth hor mone (GH) and in su lin-like growth fac tor-1 

(IGF-1) lev els. Pa tients will be ran dom ized 3:1 to re ceive the octreotide im plant or monthly in jec tions of 

octreotide (Sandostatin LAR). The pri mary ef fi cacy end point of the trial will be the sup pres sion of GH and 

IGF-1. Indevus ex pects that this trial will serve as the basis for US and international marketing 

applications. 

Sales/An a lyst Com ment: Sandostatin/Sandostatin LAR sales were up 6% in lo cal cur rency terms in 

2008 to $1.1 bil lion due to in creas ing use of the once-monthly Sandostatin LAR ver sion, which ac counts 

for 85% of net sales. Sandostatin was Novartis’ num ber five phar ma ceu ti cal prod uct in 2008. Novartis 

notes that new com pe ti tion in the USA has had min i mal im pact on Sandostatin LAR sales in 2008. Mor gan 

Stan ley an a lysts (Jan u ary 2009) fore cast peak sales of $1,142 mil lion in 2009 ($380 mil lion by 2014). 

Cowen & Co an a lysts (Au gust 2008) fore cast sales of $1,165 mil lion in 2008 (peak ing at $1,300 mil lion in 

2011 and fall ing to $600 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe riod to the end of Sep - 

tem ber 2008, Sandostatin was Novartis’ num ber seven in ter na tional phar ma ceu ti cal prod uct, ac count ing 

for 2.7% share of au dited cor po rate pharmaceutical sales, with 5% fixed rate dollar growth. 

Musculoskeletal System Agents 

PREXIGE (lumiracoxib), a sec ond-gen er a tion COX-2 in hib i tor, was first launched in Brazil in 2005 for the 

treat ment of osteoarthritis and acute pain. Ap prov als fol lowed in var i ous mar kets, in clud ing the EU, but 

not in the USA. Lumiracoxib was with drawn from many mar kets in 2007 due to safety is sues. How ever, 

Prexige con tin ues to be avail able in some coun tries, and Novartis be lieves it is a valu able ther apy op tion 

for ap pro pri ate pa tients, par tic u larly those at risk of se ri ous gas tro in tes ti nal com pli ca tions, and will con - 

tinue discussions with health authorities. 

The EU mu tual rec og ni tion pro ce dure was com pleted in Oc to ber 2006. In No vem ber 2007, how ever, the 

UK’s Med i cines and Healthcare prod ucts Reg u la tory Agency (MHRA) sus pended the li cense for Prexige 

fol low ing an in crease in the num ber of se ri ous liver re ac tions among pa tients tak ing a 100mg dose. In 

De cem ber 2007, the EMEA’s Com mit tee for Me dic i nal Prod ucts for Hu man Use (CHMP) rec om mended 

that the mar ket ing au tho ri za tions for all lumiracoxib-con tain ing med i cines be with drawn in all EU mem - 

ber states because of serious liver-related side effects. 

In the US, the FDA is sued a sec ond not ap prov able let ter for Prexige in Sep tem ber 2007. Prexige had also 

been ap proved in Can ada and in Aus tra lia, but was with drawn from these mar kets in Au gust and Oc to ber 

2007, re spec tively, be cause of liver problems. 

In Sep tem ber 2008, it was re ported that Novartis has iden ti fied a ge netic se quence that may be a risk 

fac tor for se ri ous liver in jury in pa tients re ceiv ing Prexige. Pre lim i nary re sults from genomic test ing in di - 

cate that an ex tended Ma jor Histocompatibility Com plex Class II haplotype is as so ci ated with Prexige 

hepatotoxicity. If the fi nal re sults bear out these find ings, Novartis will meet with the FDA to dis cuss what 



in for ma tion needs to be col lected to ver ify that the biomarker can iden tify those with a pre dis po si tion to 

liver toxicity caused by the drug. 

Sales/An a lyst Com ment: Prexige sales in 2007 were $91 mil lion. Mor gan Stan ley an a lysts (Jan u ary 

2009) fore cast a fall to $26 mil lion in 2008, re main ing at that level un til 2014. Cowen & Co an a lysts (Au - 

gust 2008) fore cast sales of $45 mil lion in 2008 ($40 mil lion in 2009-13). 

VOLTAREN (diclofenac so dium), an NSAID, was first launched in 1973, and later in the USA in 1988. It is 

now a ma ture prod uct and avail able world wide (as Voltarene, in French-speak ing coun tries, and as 

Voltarol, in the UK and Ire land). Prod ucts in the Voltaren range in clude: an eyedrop form, Voltaren 

Optha/Voltaren Colirio; a sol u ble tab let, Voltarol Dispersible; Voltaren Drops; a top i cal form as 

Voltaren Emulgel; Voltaren En teric Coated Tab lets; Voltaren In jec tion; an oral, 

once-/twice-daily sus tained-re lease form, Voltaren Re tard; Voltaren Rapide; an oral, once-daily sus - 

tained re lease form, Voltaren SR/Voltaren XR; Voltaren Sup pos i to ries; and Voltaren Emulgel, a 

top i cal gel for mu la tion. Voltaren Emulgel is available OTC in some markets. 

Li cens ing: In March 2008, Endo li censed the US rights to Voltaren Gel (1% diclofenac top i cal gel) from 

Novartis. Un der the terms of a five-year deal, Novartis will re ceive an upfront pay ment of $85 mil lion. 

Novartis will also be el i gi ble for a one-time mile stone pay ment of $25 mil lion if an nual sales ex ceed $300 

mil lion. Novartis will also be el i gi ble for roy al ties on net sales of Voltaren Gel in the USA. Novartis will sup - 

ply the prod uct to Endo. Voltaren Gel was ap proved in the USA in Oc to ber 2007 for the treat ment of pain 

as so ci ated with osteoarthritis in joints ame na ble to top i cal treat ment. Endo stated that it will launch 

Voltaren Gel immediately. 

Pat ents: Pat ent ex piry oc curred in Ger many in 1984, in the UK in 1986 and in the USA in 1995. 

Sales/An a lyst Com ment: The Voltaren group (ex clud ing OTC sales) was Novartis’ num ber nine phar - 

ma ceu ti cal prod uct in 2008 with sales of $814 mil lion, up 3% in lo cal cur rency terms. Mor gan Stan ley an - 

a lysts (Jan u ary 2009) fore cast sales of $755 mil lion in 2009 ($584 mil lion by 2014). Cowen & Co an a lysts 

(Au gust 2008) fore cast sales of $875 mil lion in 2008 ($970 mil lion by 2013). Ac cord ing to IMS data, in 

the 12-month pe riod to the end of Sep tem ber 2008, Voltaren was Novartis’ num ber five in ter na tional 

phar ma ceu ti cal prod uct, ac count ing for a 3.4% of au dited cor po rate phar ma ceu ti cal sales, with 4% fixed 

rate dollar growth. 

ZOMETA/ACLASTA/RECLAST (zoledronic acid), a po tent bisphosphonate bone-re sorp tion in hib i tor, 

was launched in Can ada, its first world mar ket, in 2000 for the treat ment of tu mor-in duced 

hypercalcemia (TIH). It has also been de vel oped for the treat ment of bone metastases in can cer, Paget’s 

dis ease, and os teo po ro sis. For the hypercalcemia in di ca tion, Novartis gained ap proval in the US and Eu - 

rope in 2001 and has since launched the prod uct as Zometa in over 70 mar kets. In 2005, it was launched 

in Japan. 

For the Paget’s dis ease and the os teo po ro sis in di ca tions, zoledronic acid is known as Aclasta (in Eu rope) 

and Reclast (in the USA). Aclasta was ap proved in Eu rope and Can ada for these in di ca tions in 2005. Ap - 

proval for these in di ca tions was granted in April 2007 in the USA. 

Aclasta/Reclast has also been de vel oped as a 15-min iv in fu sion, once-yearly treat ment for 

postmenopausal os teo po ro sis and other met a bolic bone dis eases. Reclast re ceived ap proval for this in di - 

ca tion in the USA and launched there in 2007. The reg u la tory sub mis sion was based on ef fi cacy and 

safety data from a three-year Piv otal Frac ture Trial in more than 7,700 women. Aclasta was also ap - 

proved for this in di ca tion in the EU and Canada in 2007. 

In 2008, Novartis sub mit ted zoledronic acid for ap proval in the USA and the EU for the treat ment of clin i - 

cal frac ture pre ven tion af ter hip frac ture. In June 2008, the US FDA broad ened the US in di ca tion for 

once-yearly zoledronic acid (Reclast) to in clude the pre ven tion of new clin i cal frac tures in pa tients fol low - 



ing a re cent low-trauma hip frac ture, and this de ci sion was based on safety and ef fi cacy data from the 

Recurrent Fracture Trial. 

In Sep tem ber 2008, Novartis re ported that once-yearly zoledronic acid 5 mg had been ap proved in the 

EU for the treat ment of os teo po ro sis in men who are at in creased risk of frac tures. The ap proval will ap ply 

in all 27 EU coun tries plus Ice land and Nor way. The la bel has also been broad ened to in clude re duc tion of 

new frac tures in osteoporotic men and postmenopausal osteoporotic women who re cently ex pe ri enced a 

hip frac ture. Ad di tion ally, the la bel also now in cludes re sults from the land mark Re cur rent Frac ture Trial 

in more than 2100 pa tients, which shows that new frac tures were de creased by 35% with zoledronic acid 

treat ment in men and postmenopausal women with a re cent low-trauma hip frac ture. Re sults which 

showed that all-cause mor tal ity was re duced by 28% in zoledronic acid-treated pa tients com pared to 

those re ceiv ing placebo are also included on the label. 

In 2004, Novartis up dated the US la bels for Zometa, warn ing of side ef fect of osteonecrosis of the jaw, al - 

though says a causal link can not be es tab lished. There were con cerns over an as so ci a tion be tween 

zoledronic acid and alendronic acid and se ri ous atrial fi bril la tion in older women, but in No vem ber 2008 

the FDA com pleted a re view of the tri als and stated that there was “no clear association.” 

Novartis could ben e fit from re cent safety con cerns sur round ing HRT, tra di tion ally the main way of treat - 

ing post-meno pausal risk of os teo po ro sis. As such, the mar ket for drugs aimed spe cif i cally at brit tle bone 

dis ease is ex pected to grow. Con tro versy sur round ing the safety of HRT was fu elled by re sults of a study 

in one mil lion women in 2003, con firm ing that the ther apy sig nif i cantly in creases (dou bles) the risk of 

breast cancer. 

Clin i cal Data: At ASCO in May 2008, Zometa dem on strated for the first time a sig nif i cant ben e fit for 

premenopausal women with hor mone-sen si tive, early-stage breast can cer. A study (ABCSG-12) pre - 

sented at ASCO showed that the ad di tion of Zometa to hor mone ther apy af ter sur gery sig nif i cantly re - 

duced the risk of re cur rence or death by 36% be yond ben e fits achieved with hor mone ther apy alone. 

Many stud ies are un der way ex am in ing the po ten tial anticancer ben e fits of Zometa. Two stud ies, AZ URE 

(pre-and post-meno pausal breast can cer) and ZEUS (pros tate can cer), have com pleted pa tient re cruit - 

ment, and re sults are expected in the next two to three years. 

Pat ent: In De cem ber, the FDA granted Zometa an ad di tional six months of mar ket ing ex clu siv ity un til 

2013 fol low ing the com ple tion of pe di at ric studies. 

Lifecycle Man age ment: In 2008 Zometa was in phase III tri als as an adjuvant ther apy in breast can - 

cer, with a first fil ing for this in di ca tion pro jected for 2010. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Procter & Gam - 

ble’s Actonel (risedronic acid), was the num ber one prod uct in the ‘Bone Cal cium Reg u la tors’ class 

(M5B), with an 18.4% mar ket share and 1% fixed rate dol lar growth. Zometa was num ber two with a 

16.1% mar ket share and 2% fixed rate dol lar growth. Merck & Co’s Fosamax (alendronic acid) fell to 

num ber three with sales down 47% in fixed dol lar terms, due to ge neric com pe ti tion, to re sult in a mar ket 

share of 15.2%. Num ber four was Roche’s Bonviva (ibandronic acid), with an 11.5% mar ket share and 


In April 2008, Novartis stated that a new study has shown that a once-a-year in fu sion of its bone drug 

Reclast was better than Actonel at in creas ing bone mass in pa tients with os teo po ro sis caused by ste roids. 

Actonel was taken as a daily pill in the trial, which in cluded 833 men and women. 

As far as new prod ucts are con cerned, Amgen is de vel op ing denosumab, a fully hu man monoclonal an - 

ti body, in phase III tri als that will eval u ate it in postmenopausal os teo po ro sis and can cer treat ment-in - 

duced bone loss (TIBL) in met a static bone dis ease. Pos i tive re sults in phase II and III tri als have been 

re ported. An a lysts ex pect a 2009 launch. A dis ad van tage of denosumab is its high pro duc tion cost. It is 



also an in ject able prod uct. NPS (USA) and li censee Nycomed Pharma launched Preotact (parathyroid 

hor mone) in Eu rope in a num ber of European countries in 2006-8. 

Sales/An a lyst Com ment: Zometa re corded sales of $1.4 bil lion in 2008, up 3% in lo cal cur rency 

terms, mak ing it Novartis’ num ber three prod uct. Novartis noted that Zometa re turned to growth in 2008 

due to im proved com pli ance for ex ist ing in di ca tions and new data show ing its sig nif i cant anticancer ben e - 

fits. In the USA, sales rose 3% to $666 mil lion. In the rest of the world, sales rose 3% to $716 mil lion. 

Aclasta/Reclast re corded sales of $254 mil lion in 2008. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast 

Zometa sales of $1,553 mil lion in 2009 (peak ing at $2,287 mil lion in 2013 and fall ing to $1,030 mil lion by 

2014). In De cem ber 2008, the an a lysts stated that Zometa is an underappreciated as set and con sen sus 

es ti mates are too low. They re port on the pos i tive feed back from cli ni cians on the use of Zometa as an 

adjuvant ther apy in breast can cer and that pre scrip tions have al ready in creased based on the results of 

the ABCSG-12 trial released in June 2008 at ASCO. 

Cowen & Co an a lysts (Au gust 2008) fore cast sales of $1,370 mil lion for Zometa alone in 2008 ($750 mil - 

lion by 2013). They give a sep a rate sales fore cast for Aclasta ($300 mil lion in 2008, $580 mil lion in 2009, 

ris ing to $675 mil lion by 2012 and fall ing to $550 mil lion by 2013). Ac cord ing to IMS, in the 12-month pe - 

riod to the end of Sep tem ber 2008, Zometa was Novartis’ num ber four in ter na tional prod uct ac count ing 

for 3.9% of au dited cor po rate phar ma ceu ti cal sales, with 14% fixed rate dollar growth. 

Parasiticidal Agents 

COARTEM (lumefantrine + artemether): Novartis an nounced in Sep tem ber 2008 that the US FDA has 

granted Pri or ity Re view for Coartem, its fixed dose com bi na tion of artemether 20 mg and lumefantrine 

120 mg, for the treat ment of ma laria. The prod uct, a three-day oral ther apy for ma laria, has been 

launched in sev eral mar kets, in clud ing French West Af rica, In do ne sia, the Phil ip pines and cer tain Eu ro - 

pean coun tries. Novartis pro vides Coartem free of profit to the pub lic sec tor in many de vel op ing coun tries 

through the Med i cines for Ma laria Ven ture (MMV). Artemether is a semi-syn thetic de riv a tives of the Chi - 

nese plant artemisinin, which has been used in Chi nese herbal med i cine for many years to treat ma laria. 

In Jan u ary 2009, Novartis and the Med i cines for Ma laria Ven ture launched a new pe di at ric for mu la tion of 

Coartem, Coartem Dispersible. Pre vi ously the very bit ter tab lets had to be crushed for chil dren to swal - 

low. The for mu la tion has re ceived ap proval in Swit zer land and in many Af ri can coun tries and will be 

provided to the public sector without profit in the developing world. 

Be cause artemisinin has poor bioavailability, semi-syn thetic de riv a tives of artemisinin, in clud ing 

artemether and artesunate have been de vel oped. How ever, their ac tiv ity is not long last ing, with sig nif i - 

cant de creases in ef fec tive ness af ter one to two hours. To coun ter this draw back, artemisinin is of ten 

given with lumefantrine (also known as benflumetol) to treat un com pli cated falciparum ma laria. 

Lumefantrine has a half-life of about 3 to 6 days. Such a treat ment is called ACT (artemisinin-based com - 

bi na tion ther apy); other ex am ples are artemether-lumefantrine, artesunate-mefloquine, 

artesunate-amodiaquine, and artesunate-sulfadoxine/pyrimethamine. Re cent tri als have shown that 

ACT is more than 90% ef fec tive, with a re cov ery of ma laria af ter three days, es pe cially for the 

chloroquine-re sis tant Plasmodium falciparum. 

Pat ents: Ciba Geigy (later part of Novartis) pat ented the com po si tion of lumefantrine with artemether in 

1990. In 1994, Ciba es tab lished a deal with Cititech, In sti tu tion of Mi cro bi ol ogy and Ep i de mi ol ogy, and 

Kunming Phar ma ceu ti cal Fac tory (all China) to co-de velop Coartem for malaria. 

Clin i cal Data: In De cem ber 2008 the US FDA re ported data in sup port of reg u la tory ap proval of 

Coartem. Coartem, given bid for three days, ap peared su pe rior to treat ment us ing the sep a rate con stit u - 

ents. Tri als con ducted by Novartis in Asia found that ap prox i mately 90% of ma laria pa tients were cured 

28 days af ter re ceiv ing treat ment with the fixed com bi na tion; the rate of cure in Eu ro pean trav el lers was 

74%, which may have been a con se quence of in com plete fol low-up for one month (re sult ing in out comes 



be ing re corded as fail ures in some cases). A re view of data from over 3400 pa tients par tic i pat ing in tri als 

of the fixed com bi na tion showed few deaths or se ri ous ad verse events; most se ri ous com pli ca tions were 

likely to be dis ease-re lated. Most ad verse events were of mild or mod er ate in ten sity; the most com mon 

ad verse events were head ache, dizziness and loss of strength, which were likely to be disease-related. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, the ma jor prod uct in the P1D class 

(Anti-Malarials) was GlaxoSmithKline’s Malarone (atovaquone + proguanil), with a 43.6% mar ket 

share and 7% fixed rate dol lar growth. Num ber two was Roche’s Lariam (mefloquine), with a 4.5% mar - 

ket share, but sales down 15% in fixed rate dol lar terms. Coartem was the num ber 11 prod uct in this 

class, with a 1.4% mar ket share and 17% fixed rate dollar growth. 

In Oc to ber 2008, the Artemisinin En ter prise Con fer ence 2008 was held at the Uni ver sity of York (UK). It 

was spon sored by the Bill and Melinda Gates Foun da tion and the Roll Back Ma laria Part ner ship. It was re - 

ported at the con fer ence that, in the face of in creas ing par a site re sis tance to anti-ma lar ial drugs, there is 

now a great deal of re li ance on artemisinin com bi na tion ther a pies to treat ma laria. How ever, ACTs are ex - 

pen sive and de mand threat ens to out strip sup ply. It was re ported at the con fer ence that de mand for 

ACTs will dou ble over the next four years, po ten tially grow ing to over 300 mil lion doses an nu ally. There is 

ex pected to be a short age in 2010 be cause of a lack of the Ar te mi sia annua worm wood plant, which pro - 

vides the raw ma te rial for artemisinin and its semi-syn thetic de riv a tives. The Cen tre for Novel Ag ri cul - 

tural Prod ucts at the Uni ver sity of York is us ing plant breed ing tech nol o gies in or der to cre ate crops that 

pro duce higher yields of artemisinin. The In sti tute for One World Health is us ing fer men ta tion com bined 

with in no va tive syn thetic chem is try to pro duce a sta ble sec ond source of artemisinin (semi-syn thetic) to 

sup ple ment ex ist ing nat u ral sources. Also, the non-profit Med i cines for Ma laria Ven ture is work ing to de - 

velop syn thetic artemisinin-like drugs. These ex per i men tal drugs have been shown to cure malaria in 

mice in just one dose and it is reported that clinical trials in humans will begin in 2009. 

Respiratory System Agents 

FORADIL (formoterol), a long-act ing, beta-2 ag o nist (LABA) in sin gle-dose dry-pow der form, in di cated 

in the treat ment of asthma, was first launched un der li cense from Yamanouchi by Novartis in 1990. It is 

now avail able in over 80 coun tries world wide (out side Ja pan) via Novartis. It is also used in COPD. Foradil 

is for mu lated for use with the Aeroliser de vice, a sin gle-dose ad min is tra tion in haler which al lows pa - 

tients to con firm that they have taken their medication. 

In 2005, the FDA asked GSK, which mar kets the LABAs Advair (fluticasone + salmeterol) and Serevent 

(salmeterol), and Novartis (Foradil) to add new warn ings to their la bels stat ing that the drugs could in - 

crease the chances of se vere asthma ep i sodes that could re sult in death. La bels for these prod ucts were 

up dated in 2006. In March 2008, US health of fi cials re quested more in for ma tion from Novartis and other 

man u fac tur ers of prod ucts con tain ing LABAs to fur ther an a lyze the safety of their med i cines. The prod - 

ucts in cluded Foradil, Advair, Serevent and AstraZeneca’s Symbicort (budesonide + formoterol). In Oc - 

to ber 2008, it was re ported that the safety of these LABA-con tain ing prod ucts will be dis cussed at a 

two-day joint meet ing of the FDA’s Pul mo nary-Al lergy Drugs, Drug Safety and Risk Man age ment, and 

Pe di at ric Ad vi sory Com mit tees in De cem ber 2008. This will be the third com mit tee re view of the class, 

con tin u ing the FDA’s en quiry into the ben e fits and risks of the LABA class for the treat ment of asthma in 

chil dren and adults in light of an ob served in creased risk of asthma-re lated deaths. At the meet ing the 

ad vi sory com mit tee rec om mended the with drawal of the asthma in di ca tion for Foradil and Serevent, due 

to the risks of the drugs out weigh ing the benefits. The recommendation did not apply to Advair and 

Symbicort. 

Li cens ing: Foradil was li censed-in from Yamanouchi (now Astellas, Ja pan) in 1986 for all mar kets out - 

side Ja pan. It was first launched in Ja pan in 1986 by orig i na tor Yamanouchi and Aventis (now 

sanofi-aventis, France). Schering-Plough (USA) ac quired US mar ket ing & dis tri bu tion rights in 2002. 



Lifecycle Man age ment: In 1998, Novartis and SkyePharma (UK) an nounced an agree ment to jointly 

de velop a new for mu la tion of Foradil, us ing SkyePharma’s pat ented multi-dose dry pow der in haler 

(MDDPI) de vice Certihaler. Novartis was to re ceive an ex clu sive world wide li cense to mar ket the Foradil 

Certihaler. In 2002, it was filed for ap proval by Novartis in the USA and Eu rope, and an ap prov able let ter 

was re ceived from the FDA in 2003. Since March 2003, it has been ap proved in Swit zer land, Aus tria, Fin - 

land, Por tu gal, the Neth er lands, and Ger many. In the USA, Foradil Certihaler was ap proved in 2006 but 

not launched by Novartis due to lim ited sales po ten tial. In late 2008 it was re ported that SkyePharma had 

been in dis cus sions with a third-party (not Novartis) to com mer cial ize the prod uct with a launch set for 

2009, but the de ci sion of the FDA ad vi sory com mit tee in De cem ber 2008 to with draw the asthma in di ca - 

tion from Foradil, means that now the product is unlikely to be commercialized in the USA. 

In 2003, Novartis signed a deal with Ivax (now part of Teva, Is rael) re gard ing Ivax’s new MDDPI Airmax. 

The agree ment cov ers the use of Airmax to de liver Novartis’ Foradil and Miflonide (budesonide) in Eu - 

rope and other coun tries. 

In 2005, Chiesi (It aly) signed a li cens ing and sup ply deal with Novartis re gard ing Chiesi’s Modulite 

HFA-based pres sur ized me tered-dose in haler (pMDI) ver sion of formoterol. Un der the terms of the deal, 

Novartis will have semi-ex clu sive pro mo tion, sales and dis tri bu tion rights for the prod uct fol low ing ap - 

proval in Den mark, France, Ger many, Greece, Neth er lands, South Af rica, Spain, Switzerland and Turkey. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Foradil was the num ber five prod - 

uct in the ‘B-2 Stim u lants’ class (R3A), with an 8.4% mar ket share, but sales down 4% in fixed rate dol lar 

terms. The class was led by Sepracor’s Xopenex (levosalbutamol), with a 17.6% mar ket share and 10% 

fixed rate dol lar growth. Num ber two was GSK’s Vento lin (sal buta mol), with an 11.7% mar ket share 

and 7% fixed rate dol lar growth. GlaxoSmithKline’s Serevent (salmeterol) was num ber three, with an 

11.0% mar ket share and sales down 11% in fixed rate dol lar terms. Num ber four was Teva’s branded ge - 

neric sal buta mol prod uct, Salamol, with an 11% mar ket share and 33% growth. 

The FDA’s ad vi sory com mit tee rec om men da tion for with drawal of the asthma in di ca tion ap plied to all 

long-act ing beta-agonists used as monotherapy, but not to prod ucts where the LABA is used in com bi na - 

tion with a corticosteroid, such as GSK’s Advair and AstraZeneca’s Symbicort. Foradil will no lon ger be 

able to com pete against these two prod ucts. Advair is re ported to have largely re placed the use of 

Serevent and the use of Symbicort in the US mar ket is grow ing (it was only launched in June 2007). 

Sales/An a lyst Com ment: Foradil was Novartis’ num ber 16 prod uct in 2008 with global sales of $387 

mil lion ($373 mil lion out side the USA), but zero growth in lo cal cur rency terms. Mor gan Stan ley an a lysts 

(Jan u ary 2009) fore cast 2009 sales of $399 mil lion ($462 mil lion by 2014). Cowen & Co an a lysts (Au gust 

2008) fore cast sales of $415 mil lion in 2008 ($430 mil lion in 2009 and $250 million by 2013). 

MIFLONIDE (budesonide) is a sec ond gen er a tion in haled corticosteroid, mar keted by Novartis. 

Lifecycle Man age ment: In 2003, Novartis signed a deal with Ivax (now part of Teva) re gard ing Ivax’s 

MDDPI Airmax. The deal cov ers the use of Airmax to de liver the Novartis re spi ra tory drugs Foradil 

(formoterol) and Miflonide. 

XOLAIR (omalizumab), a hu man ized anti-IgE monoclonal an ti body, was first launched in 2003 in the 

USA for the treat ment of mod er ate-to-se vere al ler gic asthma in ad o les cents and adults. The FDA had re - 

quested new platelet mon i tor ing data and more pre clin i cal and clin i cal anal y sis and pharmacokinetics 

prior to ap proval. The ad vi sory panel agreed that Xolair had a fa vor able risk-ben e fit pro file when the con - 

di tion is in ad e quately con trolled with in haled corticosteroids in pa tients aged 12 to 65 years but the po - 

ten tial for in creased risk of can cer is still a cause for con cern with the FDA. Xolair was also launched in 

Aus tra lia in 2003. It is now re ported to be available in over 50 markets worldwide. 



Genentech and Novartis, which share co-mar ket ing rights in the USA, filed a Biologics Li cens ing Ap pli ca - 

tion (BLA) in the USA in 2000, which was ap proved in 2003. In 2004, Novartis re sub mit ted its ap pli ca tion 

for the treat ment of se vere al ler gic asthma to the Com mit tee for Me dic i nal Prod ucts for Hu man Use 

(CHMP) in Eu rope. This is a slightly nar rower in di ca tion that ap proved in the USA where it can also be 

used in pa tients with mod er ate dis ease. It gained EU ap proval in 2005, and was launched in the UK, Den - 

mark, Po land, the Neth er lands and Ger many. Launches have taken place slowly world wide, most re - 

cently in 2008 in Rus sia. Xolair was filed for ap proval in Ja pan in 2006 and received approval in January 

2009. 

Phase III tri als have been com pleted (with Tanox and Genentech) in chil dren aged be tween six and 12 

years with mod er ate-to-se vere, per sis tent and in ad e quately con trolled al ler gic asthma. An ap proval in 

this pa tient group could have a high im pact on sales. In De cem ber 2008, Xolair was sub mit ted for use in 

chil dren from six to less than 12 years of age in the EU by Novartis and by Genentech in the USA. A new 

liq uid for mu la tion re ceived a pos i tive rec om men da tion in the EU in November 2008. 

Li cens ing: Genentech and Novartis share US co-mar ket ing rights. A 2003 co-mar ket ing deal with 

Sankyo for Ja pan was ter mi nated in 2006, when Daiichi Sankyo re turned rights to Novartis. 

In 1996, orig i na tor Tanox (now part of Genentech), Ciba and Genentech set tled law suits filed against 

each other re lat ing to the de vel op ment of monoclonal an ti body prod ucts di rected against IgE. Un der the 

terms of the set tle ment, Novartis will share mar ket ing op por tu ni ties with Genentech in the USA and Eu - 

rope. Roche, Genentech’s par ent com pany, will also have an op tion to par tic i pate in mar ket ing in Ja pan. 

Tanox will re ceive an ini tial pay ment from Genentech, as well as mile stones. Tanox will also re ceive roy al - 

ties from sales of the prod uct world wide, ex cept for Tai wan, China, Hong Kong, Sin ga pore, and South Ko - 

rea, where Tanox and Novartis will co-de velop the prod uct. In January 2007, Genentech acquired Tanox. 

Clin i cal Data: Omalizumab is the first of a new class of ther a pies for asthma that tar get im mu no glob u lin 

E, the an ti body trig ger of al ler gic re ac tions. It is ad min is tered by sub cu ta ne ous in jec tion and binds to free 

IgE in the blood. Ad min is tra tion is likely to be once a month. 

In Feb ru ary 2005, it was re ported by Novartis that a new anal y sis of re sults from seven clin i cal stud ies 

shows that Xolair sig nif i cantly re duced the num ber of asthma at tacks and al most halved the rate of 

emer gency vis its in pa tients with se vere asthma. The stud ies in volved more than 4,300 pa tients with se - 

vere per sis tent asthma, who were in ad e quately con trolled de spite re ceiv ing the ther apy spec i fied in cur - 

rent guide lines. The sum mary of data ap peared in Al lergy, the peer-re viewed jour nal of the Eu ro pean 

Acad emy of Allergology and Clin i cal Im mu nol ogy (EAACI). The same pub li ca tion con tains the first de - 

tailed re sults from one of the tri als, IN NO VATE, in di cat ing that “omalizumab is an ef fec tive add-on ther - 

apy for these dif fi cult-to-treat patients who have an important unmet medical need.” 

Com pe ti tion: Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Xolair was the 

lead ing prod uct in the R3X class (‘All Other Anti-Asthma and COPD Prod ucts’) with an 80% mar ket share, 

but sales down 1% in fixed rate dol lar terms. Servier’s Pneumorel (fenspiride) was num ber two, with an 

8.2% mar ket share and 4% fixed rate dol lar growth. Wyeth’s Primatene (ephed rine + theophylline + 

epinephine) was third, with a 2.1% mar ket share and 34% fixed rate dollar growth. 

Sales/An a lyst Com ment: In 2008, Xolair sales were $211 mil lion, up 42% in lo cal cur rency terms. 

Genentech re ported sales of $517 mil lion in the USA in 2008. Mor gan Stan ley an a lysts (Jan u ary 2009) 

fore cast sales of $217 mil lion in 2009 ($256 mil lion by 2011-14). Cowen & Co an a lysts (Au gust 2008) 

fore cast sales of $190 mil lion in 2008 ($300 million by 2013). 

ZADITEN (ketotifen), a non-steroidal anti-in flam ma tory agent, first launched in 1979. It is used in the 

treat ment of asthma, al ler gies, and ec zema. Oral, oph thal mic, and top i cal for mu la tions are avail able. It is 

now open to ge neric com pe ti tion and sales are in decline. 



Li cens ing: In 2002, Ca na dian rights were li censed to PanGeo Pharma. 

Sensory Organ Agents/Ophthalmologicals 

LUCENTIS (ranibizumab) is a monoclonal an ti body, orig i nally de vel oped by Genentech (now part of 

Roche, Swit zer land) in col lab o ra tion with li censee Novartis, for the treat ment of wet age-re lated macular 

de gen er a tion (AMD). It was first launched by Novartis in Fin land in 2004. Genentech filed a BLA with the 

FDA for the treat ment of AMD in 2005 and ap proval was granted in June 2006, when Lucentis was 

launched in the USA, its first world mar ket, by Genentech, which holds North Amer i can rights. In 2006, it 

was also launched in Aus tria, Swit zer land and Nor way. It was ap proved in the EU in Jan u ary 2007. 2007 

saw launches in a num ber of coun tries, in clud ing the UK, Ire land, Ger many, Den mark, In do ne sia, Swe - 

den, Bul garia, Po land, Bel gium, Can ada, France, Greece, It aly, Aus tra lia, New Zea land, Spain, Ar gen tina, 

Mex ico, Hun gary, Thai land and South Ko rea. In 2008, it was launched in Ku wait, Pa ki stan and Sin ga pore. 

In Jan u ary 2009, Novartis noted that Lucentis is now ap proved in more than 70 markets. It was approved 

in Japan in January 2009. 

Lucentis is the first treat ment for wet AMD that has been shown to im prove vi sion rather than slow vi sion 

loss, and is ex pected to be come a gold stan dard treat ment. Novartis is also de vel op ing Lucentis for the 

treat ment of di a betic macular edema (DME). In No vem ber 2008, Novartis stated that Lucentis had 

shown “suc cess ful re sults in the phase II RE SOLVE study with sta tis ti cally sig nif i cant vi sion im prove ment 

com pared to pla cebo in pa tients with DME, an eye con di tion linked with high blood sugar that causes 

blind ness. The phase III RE STORE study was started in May 2008 in DME, with a sub mis sion in Europe 

planned for 2010.” 

In the UK there have been prob lems with NHS fund ing for Lucentis, but in late 2008 Novartis came to an 

agree ment with the UK De part ment of Health whereby it agreed to pay for use of the drug be yond 14 in - 

jec tions if nec es sary. 

Li cens ing: In 2003, Genentech granted Novartis an ex clu sive li cense to de velop and mar ket Lucentis 

out side North Amer ica for in di ca tions re lated to dis eases of the eye. Un der the terms of the deal, the com - 

pa nies shared cer tain global de vel op ment costs. Genentech will re ceive an upfront fee, mile stone pay - 

ments and roy al ties from prod uct sales out side North Amer ica. North Amer i can mar ket ing rights will be 

retained by Genentech. 

Clin i cal Data: Data from the AN CHOR study, pre sented in 2006, com par ing Lucentis to Visudyne 

(verteporfin) photodynamic ther apy (PDT), showed a dif fer ence in mean change in vi sual acu ity of 18 let - 

ters for pa tients treated with 0.3mg of Lucentis and 21 let ters for pa tients treated with 0.5mg of Lucentis 

from study en try com pared to those treated with PDT at 12 months. In the first year of this two-year 

study, pa tients treated with Lucentis gained an av er age of 8.5 let ters in the 0.3mg dose group and 11 let - 

ters in the 0.5mg dose group com pared to pa tients treated with PDT, who lost an av er age of 9.5 letters. 

QLT (Can ada) is con duct ing a phase II trial, known as RAD I CAL, com par ing Visudyne-Lucentis com bi na - 

tion ther a pies with Lucentis monotherapy in 162 sub jects with choroidal neovascularization sec ond ary to 

age-re lated macular de gen er a tion. The study is de signed to de ter mine if the com bi na tion ther apy re - 

duces retreatment rates com pared with Lucentis monotherapy. Six month re sults re ported in De cem ber 

2008 showed that mean cu mu la tive treat ments were lower in the com bi na tion groups than the 

monotherapy group. 

Com pe ti tion: About one third of pa tients in clin i cal tri als of Lucentis dem on strated im proved vi sion af ter 

12 months, giv ing it a firm ad van tage over Pfizer’s ri val VEGF in hib i tor Macugen (pegaptanib). Pfizer ap - 

peared to have had the ad van tage of six-weekly dos ing with Macugen, Lucentis has a broader la bel. 

Macugen was ap proved by the FDA in 2004 (and in the EU in 2006). 



Novartis/QLT’s Visudyne photodynamic ther apy, ap proved in 2000, was the first prod uct for macular de - 

gen er a tion. It is in di cated for pre dom i nantly clas sic dis ease. Genentech car ried out a phase III trial that 

com pared Lucentis against Visudyne in wet AMD pa tients. On av er age, pa tients treated with Lucentis im - 

proved their vi sual acu ity and those treated with Visudyne de clined. In jected in the arm, Visudyne is ac ti - 

vated by shin ing a cold la ser into the eye. It is ex pen sive, at about $1,500 per dose, but re quires only four 

or five doses for a full treatment. 

OPKO Health (USA) is de vel op ing a siRNA agent, bevasiranib, in phase III tri als. 

Sev eral com pa nies are ex plor ing RNA in ter fer ence as a treat ment for AMD. Sirna and Acu ity are re ported 

to be study ing how to use RNA to shut down the pro duc tion of VEGF in stead of blocking it. 

Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Lucentis was the lead ing prod - 

uct in the ‘Oc u lar Antineovascularisation Prod ucts’ class (S1P), with an 89.7% mar ket share and 50% 

fixed rate dol lar growth. Visudyne was num ber two, with an 8.7% mar ket share, but sales were down 

42% in fixed rate dol lar terms. Macugen was num ber three, with a 1.7% mar ket share and 2% fixed rate 


Sales/An a lyst Com ment: Lucentis sales stood at $886 mil lion in 2008, up 122% in lo cal cur rency 

terms, and it was Novartis’ num ber seven phar ma ceu ti cal prod uct. Mor gan Stan ley an a lysts (Jan u ary 

2009) fore cast sales of $1,006 mil lion in 2009 ($1,345 mil lion by 2014). Cowen & Co an a lysts (Au gust 

2008) fore cast sales of $975 mil lion in 2008 ($1,500 mil lion by 2013). Ac cord ing to IMS, in the 12-month 

pe riod to the end of Sep tem ber 2008 Lucentis was Novartis’ num ber ten in ter na tional phar ma ceu ti cal 

prod uct, ac count ing for 1.9% of au dited cor po rate phar ma ceu ti cal sales, with 312% fixed rate dollar 

growth. 

VISUDYNE (verteporfin), a benzoporphyrin de riv a tive, was launched in Swit zer land, its first mar ket, in 

1999, for the treat ment of wet, age-re lated macular de gen er a tion (AMD), in pa tients with pre dom i nantly 

clas sic subfoveal choroidal neovascularization (CNV). AMD is a com mon cause of blind ness in the over 

50s. Visudyne has been ap proved in over 65 coun tries world wide for its main in di ca tion and in more than 

45 (in clud ing Eu rope, the USA and Can ada) for ad di tional in di ca tions. The drug’s in di ca tions have been 

ex panded in Eu rope to the treat ment of subfoveal CNV sec ond ary to patho logic my o pia and the treat - 

ment of oc cult CNV sec ond ary to AMD. How ever, in April 2007, the CHMP rec om mended that the oc cult 

CNV in di ca tion be de leted. It has been ad di tion ally ap proved in the USA for macular con di tions such as 

pathologic myopia and ocular histoplasmosis syndrome. 

When stim u lated by light, verteporfin de stroys sur round ing tis sue. As the com pound is sen si tive to long 

wave lengths of light, it is ca pa ble of ac ti va tion deep in tu mors and skin. The drug is given by in jec tion and 

then ex posed to light from a la ser, which ac ti vates its cytotoxicity. The ad min is tra tion pro ce dure for 

Visudyne takes less than 30 min utes. Visudyne was also in phase III tri als for the oc cult form of AMD and 

phase II tri als in early 2005 for the minimally classic form of AMD. 

Li cens ing: Verteporfin was dis cov ered at the Uni ver sity of Brit ish Co lum bia (Can ada) and was co-de vel - 

oped by QLT Photo Thera peu tics (Can ada) and CIBA Vi sion. The Uni ver sity of Brit ish Co lom bia li censed 

verteporfin to QLT, which in turn sublicensed it to CIBA Vi sion in 1995 for world wide co-de vel op ment and 

co-mar ket ing. The deal be tween the two com pa nies cov ers cor neal neovascularization, intraocular tu - 

mors, di a betic retinopathy and eval u a tion of other photosensitizers. It was later ex tended to cover cu ta - 

ne ous on col ogy and pso ri a sis. The de vel op ment costs will be di vided 60% Novartis and 40% QLT 

Photo Thera peu tics, with prof its from prod uct sales shared on a 50:50 ba sis. In 2000, QLT ex panded its 

deal with Novartis. The two com pa nies will equally share de vel op ment costs and net sales of other com - 

pounds for the treat ment of dis eases char ac ter ized by neurovascularization. CIBA Vi sion will main tain 

sales and mar ket ing re spon si bil i ties. Ipsen (France) has European development rights to Visudyne in 

cancerous/pre-cancerous indications. 



Clin i cal Data: In March 2008, Novartis an nounced that re sults from a phase II study, in pa tients with 

subfoveal choroidal neovascularization (CNV) sec ond ary to AMD, showed that a com bi na tion ther apy of 

Visudyne fol lowed by Avastin (bevacizumab) re duced, by half, the num ber of treat ments re quired dur ing 

the first six months to gain sim i lar vi sual acu ity com pared to Avastin monotherapy, with which all pa tients 

re quired additional treatments. 

QLT (Can ada) is con duct ing a phase II trial, known as RAD I CAL, com par ing Visudyne-Lucentis com bi na - 

tion ther a pies with Lucentis monotherapy in 162 sub jects with choroidal neovascularization sec ond ary to 

age-re lated macular de gen er a tion. The study is de signed to de ter mine if the com bi na tion ther apy re - 

duces retreatment rates com pared with Lucentis monotherapy. Six month re sults re ported in De cem ber 

2008 showed that mean cu mu la tive treat ments were lower in the com bi na tion groups than the 

monotherapy group. 

Pat ents: QLT Photo Thera peu tics has an ex clu sive world wide li cense from the Uni ver sity of Brit ish Co - 

lom bia for all pat ents and know-how re lat ing to verteporfin and its use in PDT. 

Com pe ti tion: Main com pe ti tion co mes from Genentech and Novartis’ Lucentis (ranibizumab). 

Genentech has car ried out a phase III trial that com pared Lucentis against Visudyne in wet AMD pa tients. 

On av er age, pa tients treated with Lucentis im proved their vi sual acu ity and those treated with Visudyne 

de clined. Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Lucentis was the lead - 

ing prod uct in the ‘Oc u lar Antineovascularisation Prod ucts’ class (S1P), with an 89.7% mar ket share and 

50% fixed rate dol lar growth. Visudyne was num ber two, with an 8.7% mar ket share, but sales were 

down 42% in fixed rate dol lar terms. Macugen was num ber three, with a 1.7% mar ket share and 2% 

fixed rate dollar growth. 

Sales/An a lysts Com ment: Mor gan Stan ley an a lysts (Jan u ary 2009) pre dict sales of $106 mil lion in 

2009 ($74 mil lion by 2014). 

Systemic Anti-Infective Agents 

CEFDINIR NOVT (cefdinir): In 2007, Novartis launched a ge neric ver sion of the an ti bi otic cefdinir (ge - 

neric ver sion of Abbott’s Omnicef) in the USA. Cefdinir is re ported to be one of the most widely pre - 

scribed cephalosporin an ti bi ot ics in the US. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Cefdinir Novt was the num ber 

eight prod uct in the J1D class (Cephalosporins), with sales of $147 mil lion, a 1.4% mar ket share and 

113% fixed rate dol lar growth, ac cord ing to IMS. The lead ing prod uct in this class was Roche’s Rocephin 

(ceftriaxone), with a 3.1% mar ket share, but sales down by 13% in fixed rate dol lar terms. Num ber two 

was GlaxoSmithKline’s Zinnat (cefuroxime axetil), with a 2.7% mar ket share and sales down by 9% in 

fixed rate dol lar terms. Num ber three was Shionogi’s Flomox (cefcapene pivoxil), with a 2.6% mar ket 

share and sales down by 3% in fixed rate dol lar terms. Num ber four was GlaxoSmithKline’s Fortum 

(ceftazidime), with a 2.3% mar ket share and sales down by 12% in fixed rate dol lar terms. Num ber five 

was Bris tol-Myers Squibb’s Maxipime (cefepime), with a 1.8% mar ket share and sales down by 40% in 

fixed rate dollar terms. 

CUBICIN (daptomycin) is a lipopeptide an ti bi otic for the treat ment of in fec tious dis eases caused by 

Staph y lo coc cus aureus and vancomycin-re sis tant enterococci (VRE). It was orig i nally launched by orig i - 

na tor Cub ist Pharma in the USA in 2003. Ob tained via the Chiron ac qui si tion, Cubicin is the first Novartis 

prod uct for the hos pi tal in fec tions mar ket. Daptomycin is a fer men ta tion prod uct of Streptomyces 

roseosporus and is wa ter-sol u ble. Cubicin was ap proved in the EU in 2006. In 2006, Novartis launched it 

in the UK, Ire land, Nor way, Ger many, the Neth er lands, Fin land, Aus tria, Spain, Den mark, Ger many and 

Swe den. In 2007, Novartis launched it in It aly, France, Swit zer land, Poland, Slovenia, Argentina, Greece 

and Taiwan. 



In Au gust 2007, Novartis re ceived Eu ro pean ap proval to ex pand the in di ca tions of daptomycin to in clude 

right-sided in fec tive endocarditis (RIE) and Staph y lo coc cus aureus bacteremia (SAB), in cases as so ci - 

ated with RIE or com pli cated skin and soft-tis sue in fec tions (cSSTI). In Sep tem ber 2007, Novartis an - 

nounced that it had launched Cubicin for the treat ment of both methicillin-sen si tive and -re sis tant S. 

aureus (MSSA and MRSA) blood stream in fec tions (bacteremia) and RIE in the UK. 

Li cens ing: Orig i na tor Cub ist Pharmaceuticals (USA) has rights in North Amer ica, Ja pan, Is rael, Ko rea 

and China. In 2003, Chiron, which is now part of Novartis, ac quired rights in West ern Eu rope, East ern Eu - 

rope, the Mid dle East, Aus tra lia, New Zea land, Cen tral Amer ica, South Amer ica and In dia. In 2007, Merck 

& Co agreed with Cub ist to de velop and com mer cial ize daptomycin in Ja pan. Oryx (now part of Sepracor) 

has rights in Can ada and launched it there in early 2008. 

Com pe ti tion: Ac cord ing to IMS, in the 12-month pe riod to the end of Sep tem ber 2008, Cubicin was the 

num ber two prod uct in the ‘Other Antibacterials’ class with a 10.7% mar ket share and 43% fixed rate 

dol lar growth. Num ber one was Pfizer’s Zyvox (linezolid), with a 31.7% mar ket share and 13% fixed rate 

dol lar growth. Num ber three was sanofi-aventis’ Targocid (teicoplanin), with a 10.4% mar ket share and 


Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) put 2007 sales at $14 mil lion and fore - 

cast sales of $20 mil lion in 2008 ($125 mil lion by 2013). 

DENAVIR/VECTAVIR (penciclovir), a top i cal cream an ti vi ral for the treat ment of her pes labilis (cold 

sores). 

Li cens ing: Penciclovir was ac quired from GlaxoSmithKline in 2000 to gether with Famvir (famciclovir). 

In 2006, Novartis granted Bar rier Ther a peu tics (USA) ex clu sive rights to mar ket and dis trib ute the prod - 

uct in Canada. 

ENCEPUR (vac cine, tick borne en ceph a li tis), a tick-borne en ceph a li tis vac cine, was launched in Ger - 

many in 1991, and is now avail able in a num ber of mar kets, in clud ing Po land, Swit zer land, Swe den, Rus - 

sia, Lat via, the Czech Re pub lic and Hungary. 

FAMVIR (famciclovir), an an ti vi ral in di cated for acute her pes zoster and the treat ment or sup pres sion of 

her pes sim plex. In 2006, the FDA ap proved a sup ple men tal NDA for famciclovir as a sin gle-day treat ment 

for immunocompetent pa tients with re cur rent gen i tal her pes (two 1,000mg doses) or with re cur rent her - 

pes labialis (cold sores) (sin gle 1,500 mg dose). The de ci sion was based on re sults from two in ter na tional 

clin i cal tri als in pa tients with re cur rent gen i tal herpes and patients with cold sores. 

Li cens ing: Novartis ac quired global mar ket ing and man u fac tur ing rights to Famvir and 

Vectavir/Denavir (penciclovir) from GlaxoSmithKline in 2000. 

Pat ents: In 2004 Teva (Is rael) filed an ap pli ca tion with the FDA to sell a ge neric ver sion of Famvir. 

Novartis filed suit, charg ing that Teva in fringed on one of its five pat ents for famciclovir. Teva sought to 

chal lenge all five pat ents, but a dis trict court threw out its case re lated to the four pat ents for which 

Novartis did not sue. In March 2007, a fed eral ap peals court re versed the dis trict court’s de ci sion and re - 

in stated Teva’s pat ent case. Teva be gan sell ing its ge neric Famvir in Sep tem ber 2007, a day af ter a New 

Jer sey dis trict court de nied Novartis’ re quest for a pre lim i nary in junc tion. In de ny ing the re quest, the 

court con cluded that Novartis’ ba sic pat ent cov er ing famciclovir is ob vi ous and un en force able. Just hours 

af ter Teva be gan sell ing its prod uct, the US Court of Ap peals for the Fed eral Cir cuit tem po rarily granted 

Novartis’ emer gency mo tion for an in junc tion un til it could hear from both par ties. On Sep tem ber 28, 

how ever, the court de nied Novartis’ mo tion, al low ing Teva to re sume sales of its ge neric Famvir while 

Novartis ap peals the dis trict court rul ing. Novartis be lieves in the va lid ity of the Famvir com pound pat ent, 

which ex pires in 2010, and the Famvir method-of-use pat ents, some of which will ex pire as late as 2015. 

If Novartis wins the patent dispute, it could seek treble damages from Teva. 



Sales/An a lyst Com ment: Sales are de clin ing due to ge neric com pe ti tion. Mor gan Stan ley an a lysts 

(Jan u ary 2009) put 2007 sales at $236 mil lion and pre dict $100 mil lion in 2008 and $94 mil lion in 2009 

($81 million by 2014). 

FLUVIRIN (in flu enza vac cine): Novartis ob tained rights to Fluvirin via the 2006 pur chase of Chiron. It is 

ap proved for sale in 30 coun tries, in clud ing sev eral Eu ro pean mar kets, the US, Aus tra lia and Argentina. 

OPTAFLU (vac cine, sea sonal in flu enza, Novartis) is a sea sonal in flu enza vac cine based on novel cell cul - 

ture tech nol ogy in stead of tra di tional egg-based pro duc tion. Novartis ob tained the prod uct via the ac qui - 

si tion of Chiron. OptaFlu re ceived EU ap proval in all 27 states, as well as Ice land and Nor way in June 2007 

and was launched in Ger many and Aus tria in Sep tem ber 2007. It was launched in the UK in March 2008. 

In early 2009 it was in phase III tri als in the USA. OptaFlu showed in piv otal phase III data that it was 

highly ca pa ble of pro duc ing an im mune re sponse, at least as strong as the egg-based vac cine Agrippal 

for each of the three in flu enza strains stud ied. It was also well tol er ated, show ing no mean ing ful dif fer - 

ences in the safety pro file compared to traditional egg-based vaccines. 

QUINVAXEM (vac cine, diph the ria, tet a nus, per tus sis, hep a ti tis B, H influenzae type B, Novartis/Crucell) 

is a fully-liq uid, pentavalent vac cine for the pre ven tion of diph the ria, tet a nus, per tus sis, hep a ti tis B and 

Haemophilus influenzae type b in fec tion in chil dren. It was de vel oped by Novartis and Crucell (Neth er - 

lands). In 2006, it was granted Prequalification by the WHO, per mit ting it to be made avail able to su pra - 

na tional or ga ni za tions (ma jor cus tom ers for com bi na tion vac cines which are used in mass vac ci na tion 

pro grams in de vel op ing coun tries). Quinvaxem was launched in South Korea in 2006. 

TOBI (tobramycin) is mar keted for the treat ment of chronic Pseu do mo nas aeruginosa in fec tions in cys tic 

fi bro sis pa tients. By the age of 17, nearly 70% of peo ple with CF are in fected. TOBI is ad min is tered by 

nebulizer twice daily, for 15 min utes each time, for 28 days, fol lowed by a 28-day drug-free pe riod. 

Novartis ob tained rights to Tobi via the ac qui si tion of Chiron, in 2005. 

Lifecycle Man age ment: Novartis is de vel op ing a dry pow der prod uct, In haled TOBI, with the 

tobramycin ad min is tered via a hand-held breathe-ac ti vated de vice. It is un der go ing a mul ti na tional 

phase III trial, eval u at ing its safety and ef fi cacy in the treat ment of Pseu do mo nas aeruginosa lung in fec - 

tions in cys tic fi bro sis pa tients. In 2001, Chiron (now Novartis) and Nektar (USA) signed an agree ment 

un der which Chiron would be re spon si ble for the clin i cal de vel op ment and world wide com mer cial iza tion 

of tobramycin in haled pow der, which was granted Orphan Drug designation by the EU in 2003. 

In De cem ber 2008, Novartis ac quired the pul mo nary drug de liv ery unit of Nektar. It has ac quired spe cific 

pul mo nary de liv ery as sets, tech nol ogy, and in tel lec tual prop erty from Nektar for $115 mil lion in cash. 

Cer tain dry pow der and liq uid pul mo nary for mu la tion and man u fac tur ing as sets (in clud ing cap i tal equip - 

ment and man u fac tur ing cap i tal lease ob li ga tions) will be ac quired by Novartis. Novartis will also take on 

140 Nektar per son nel, as well as cer tain in tel lec tual prop erty and man u fac tur ing meth ods. Man u fac tur - 

ing and roy alty rights to tobramycin inhaled powder (Inhaled Tobi) will be transferred to Novartis. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, Tobi was the 

lead ing prod uct in the J1K class (Aminoglycosides), with a 33.0% mar ket share and 5% fixed rate dol lar 

growth. Its near est ri vals are Bris tol-Myers Squibb’s Amikin (amikacin), with a 4.3% mar ket share and 

sales down 6%, and Schering-Plough’s Garamycin (gentamicin), with a 4.1% mar ket share and sales 

also down 6% in fixed rate dollar terms 

Pat ents: In 2002, an ANDA for in haled tobramycin from Roxane, a sub sid iary of Boehringer Ingelheim 

(Ger many), re ceived ten ta tive FDA ap proval for sale fol low ing the ex pi ra tion of TOBI’s or phan drug ex - 

clu siv ity pe riod in De cem ber 2004. It was later with drawn, how ever, and in Oc to ber 2003, Chiron 

reached a set tle ment with Roxane, which will now not launch a ge neric com pet i tor to TOBI un til Chiron’s 

US for mu la tion patent expires in 2014. 



Sales/An a lyst Com ment: Sales in 2008 were $295 mil lion, up 6% in lo cal cur rency terms, and it was 

Novartis’ num ber 19 in ter na tional phar ma ceu ti cal prod uct. Cowen & Co an a lysts (Au gust 2008) fore cast 

sales of $295 mil lion in 2008 ($310 mil lion in 2009). They state that from 2010, sales of the cur rent TOBI 

prod uct will be re placed by the sec ond-gen er a tion dry pow der prod uct (TMB 100). They think that sales 

of the new ver sion will reach $300 mil lion by 2013. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast 

TOBI sales of $293 mil lion in 2009 ($356 million by 2013-14). 

TYZEKA/SEBIVO (telbivudine) is an oral once-daily nucleoside an a logue for the treat ment of hep a ti tis 

B. It was first launched in the USA in 2006 as Tyzeka. In 2006, it was also launched by Novartis as 

Sebivo in Can ada, Swit zer land and In do ne sia. Ap proval in the EU (where it is sold as Sebivo) was 

granted in April 2007. In 2007, it was launched in the UK, Ger many, Brazil, Aus tria, Hong Kong, Ma lay sia, 

Fin land, Thai land, the Phil ip pines, Ar gen tina, Sin ga pore, the Neth er lands and Nor way. In 2008, it was 

launched in Tai wan, It aly, the Slo vak Re pub lic, South Ko rea, Rus sia, Swe den and Pa ki stan. It has also 

been launched in China. 

In Feb ru ary 2008, it was re ported that the Eu ro pean CHMP had rec om mended that warn ings about the 

risk of pe riph eral neu rop a thy be added to the prod uct’s la bel. Sebivo has only been ap proved as a 

monotherapy and the CHMP stated that cases of pe riph eral neu rop a thy had un com monly been re ported 

in use as a monotherapy. How ever, an in creased risk of de vel op ing pe riph eral neu rop a thy was seen in a 

clin i cal trial in ves ti gat ing a com bi na tion of telbivudine and Roche’s hep a ti tis C treat ment Pegasys 

(peginterferon alfa-2a) dosed weekly. 

Li cens ing: In 2003, Novartis paid $255 mil lion for around 54% of pri vately-owned Idenix’s out stand ing 

cap i tal stock, gain ing rights to de velop and com mer cial ize telbivudine and other drug can di dates dis cov - 

ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008. In 2007, the com pa nies 

amended their deal re lat ing to telbivudine. Un der the terms of the amended deal, Idenix will dis con tinue 

all de vel op ment, man u fac tur ing, and com mer cial ac tiv i ties for the prod uct. Novartis will con tinue these 

ac tiv i ties and as sume full re spon si bil ity for on go ing and fu ture clin i cal tri als and reg u la tory fil ings. Idenix 

will receive a worldwide product sales-based royalty. 

Com pe ti tion: In the past, hep a ti tis B was mainly treated with al pha-interferons and lamivudine. How - 

ever, in 2002, Gilead’s Hepsera (adefovir dipivoxil), was first launched in the USA and this is now the 

lead ing HBV treat ment. A ma jor new oral an ti vi ral for HBV is Bris tol-Myers Squibb’s Baraclude 

(entecavir), a po tent nucleoside an a logue. Ap proved by the FDA in 2005, it has now been launched in a 

num ber of mar kets. It has dem on strated su pe rior an ti vi ral ac tiv ity com pared with con tin ued lamivudine 

in lamivudine-re frac tory pa tients. Sales are now gaining on those of Hepsera. 

Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (Jan u ary 2009) put 2007 sales at $88 mil lion and 

fore cast $230 in sales in 2008 and $346 mil lion in 2009 ($600 mil lion by 2014). 

Various 

EXJADE (deferasirox) is an oral iron che lat ing agent for the treat ment of iron over load re lated dis eases. 

It was first ap proved in the USA and Swit zer land in 2005 and launched in those coun tries in No vem ber 

2005. Ap proval in the EU came in Au gust 2006, and a large num ber of launches across Eu rope fol lowed as 

well as launches in Latin Amer ica and Asia. It was also launched in a num ber of mar kets in 2007, in clud ing 

Greece, South Af rica, Chile, New Zea land, Fin land, Bel gium, Tur key, Tai wan, Ec ua dor, Bul garia and Sin - 

ga pore. It was launched in Uru guay in 2008. Deferasirox has Or phan Drug Sta tus in the USA, EU and 

Aus tra lia. It was filed in Ja pan in March 2007, a year ahead of sched ule, and launched in Ja pan in June 

2008. It is avail able in over 90 coun tries world wide, according to Novartis in January 2009. 

The phase III stud ies in volved around 800 adults and chil dren with beta-thalassemia myelodysplastic 

syn drome. Thalassemia is a con gen i tal dis or der re sult ing in pro duc tion of ab nor mal he mo glo bin. Treat - 



ment re quires fre quent blood trans fu sions that can sub se quently lead to too much iron in body or gans. 

How ever, the stud ies also en rolled pa tients with other trans fu sion-de pend ent anemias, in clud ing sickle 

cell dis ease. With a once-daily oral dose, deferasirox is re plac ing Novartis’ older prod uct treat ment, 

Desferal, which is ad min is tered via a daily subcutaneous infusion over 8-12 hours. 

Exjade is now be ing stud ied in pa tients with non-transfusional-re lated iron over load. Phase I/II safety 

and ef fi cacy stud ies are en roll ing pa tients, with the first data ex pected in 2008. 

Com pe ti tion: In the 12-month pe riod to the end of Sep tem ber 2008, Exjade was the num ber one prod - 

uct in the V3F class (Iron-che lat ing Agents), with an 85.8% mar ket share and 35% fixed rate dol lar 

growth. Num ber two was the older Novartis prod uct Desferal (deferoxamine), with a 7.0% mar ket 

share but sales down by 14% in fixed rate dol lar terms. In April 2008, it was re ported that Cipla (In dia) 

was plan ning to launch a ge neric ver sion of Exjade on the Indian market. 

Sales/An a lyst Com ment: In 2008, sales were $531 mil lion, up 45% in lo cal cur rency terms, and it was 

Novartis’ num ber 11 phar ma ceu ti cal prod uct. Mor gan Stan ley an a lysts (Jan u ary 2009) fore cast sales of 

$627 mil lion in 2009 ($901 mil lion by 2014). Cowen & Co an a lysts (Au gust 2008) fore cast sales of $515 

mil lion in 2008 ($825 million by 2013). 

Generics 

Novartis is a ma jor player in the world generics mar ket via its generics di vi sion Sandoz, which ac counted 

for 18.2% of to tal com pany sales in 2008. Sandoz is the world’s num ber two generics com pany and is 

lead ing the in dus try in dif fi cult-to-make generics based on spe cial ized for mu la tions rang ing from trans - 

derm al patches and im plants to ex tended-re lease tablets. 

In 2008, Sandoz’s net sales rose 5.4% to $7.6 bil lion. Growth was driven by im proved per for mances out - 

side the USA to achieve sales of $5,791 mil lion up 5% in lo cal cur rency terms. Growth was par tic u larly led 

by mar kets in Cen tral and East ern Eu rope, up 13% in lo cal cur rency terms, with Rus sia the ma jor growth 

mar ket. Growth was also good in Ger many, Can ada, Tur key and Brazil. There was how ever a 10% de - 

cline in the US mar ket, down to $1,766 mil lion, due to a lack of new prod uct launches in 2008. Mor gan 

Stan ley an a lysts (Jan u ary 2009) ex pect Sandoz sales to grow strongly to $7,820 mil lion in 2009 then up 

to $9,906 million in 2014. 

The US ac counted for 23% of Sandoz net sales in 2008, down from 27% in 2007. There was a lack of ma - 

jor launches in 2008, but re cent key launches in that coun try have in cluded the an ti bi otic cefdinir (ge neric 

ver sion of Abbott’s Omnicef), one of the most widely pre scribed cephalosporin an ti bi ot ics in the US; ad - 

di tional dos ages of metoprolol succinate (AstraZeneca’s Toprol-XL), a drug used to treat high blood 

pres sure and heart fail ure, in a state-of-the art sus tained-re lease for mu la tion; and ipratropium albuterol 

(Boehringer Ingelheim’s Combivent), a med i cine used to treat re spi ra tory dis or ders, an im por tant stra - 

te gic mile stone for Sandoz be cause treat ments for re spi ra tory dis eases rep re sent a ma jor growth ini tia - 

tive. Growth in the US was also driven by the launch of au tho rized generics that in clude amlodipine + 

benazepril com bi na tion (Novartis’ own Lotrel) and ondansetron (GSK’s Zofran). In Eu rope, Sandoz 

launched leuprorelin, a treat ment for pros tate can cer, in an im plant formulation injected into the 

abdominal skin of patients. 

Also sup port ing growth were the Hexal and Eon Labs ac qui si tions. These com pa nies were bought by 

Novartis in 2005 for ap prox i mately $8 bil lion. The trans ac tion brought to Novartis Hexal’s mar ket lead er - 

ship in Ger many and Eon Labs’ strong po si tion in the US for dif fi cult-to-make generics. The ac qui si tions 

sig nif i cantly strength ened Sandoz’ tech nol ogy base and ex panded the al ready strong ca pa bil i ties in phar - 

ma ceu ti cal, biopharmaceuticals and anti-infectives. 



Crown ing Sandoz’s dif fi cult-to-make strat egy are biosimilars, fol low-on ver sions of ex ist ing bi o log i cal 

med i cines. In 2007, Sandoz be came the first com pany to re ceive Eu ro pean Com mis sion ap proval for a 

biosimilar epoetin alfa (EPO). The Sandoz ver sion of epoetin alfa was launched in Ger many and the Neth - 

er lands in 2007. In a pre ce dent-set ting de ci sion in April 2006, Sandoz be came the first com pany to ob - 

tain Eu ro pean ap proval for a biosimilar med i cine, the hu man growth hor mone Omnitrope. Ap proval of 

Omnitrope in the US fol lowed a month later. As more biopharmaceuticals lose pat ent pro tec tion in com - 

ing years, biosimilar prod ucts are ex pected to play a key role in the growth strat egy of Sandoz. It has 

gone on to de velop biosimilar ver sions of filgrastim (Zarzio/Filgrastim Hexal), which was ap proved in the 

EU in Feb ru ary 2009, and Extavia (in ter feron beta-1b), a biosimilar ver sion of Bayer’s 

Betaseron/Betaferon. Novartis gained rights to de velop Extavia, its own branded ver sion of Betaferon, 

un der an agree ment with Bayer Schering fol low ing Novartis’ ac qui si tion of Chiron. In Jan u ary 2009, 

Extavia was launched in Ger many and Den mark, with fur ther European launches planned. A US launch is 

also planned for 2009. 

For 2008, Sandoz re ported that it had re ceived more than 100 prod uct ap prov als world wide and made 

more than 1500 sub mis sions. Fur ther more, the com pany has more than 880 pro jects in de vel op ment, 

in clud ing those de vel oped in-house, li censed pro jects and ac tive phar ma ceu ti cal in ter me di ates. At the 

end of 2008 the com pany had 123 ANDAs pend ing at the FDA, in clud ing 68 para graph IV filings and 20 

first-to-file. 

In July 2008, Sandoz filed an ap pli ca tion with the US FDA to sell a ge neric ver sion of the Teva mul ti ple 

scle ro sis drug Copaxone (glatiramer ac e tate), which has been de vel oped by Momenta (USA). Teva 

main tains that it has pat ent pro tec tion on Copaxone in the USA un til May 2014 and in much of Eu rope un - 

til 2015. Teva has re sponded by fil ing a suit against Novartis and Momenta in the US Dis trict Court in 

Manhattan. 

In Au gust 2008, Sandoz was also re ported to have sought US FDA ap proval for a ge neric ver sion of 

Bayer’s lead ing oral con tra cep tive YAZ, pro vok ing a pat ent in fringe ment law suit from Bayer. Bayer says 

that mar ket ing ex clu siv ity for YAZ, the lower dose ver sion of its Yasmin oral con tra cep tive, runs until 

March 2009. 

Con sumer Prod ucts 

The Con sumer Health di vi sion cov ers all Novartis non-eth i cal phar ma ceu ti cal units (OTC, An i mal Health 

and CIBA Vi sion). In 2007, Novartis sold its Med i cal Nu tri tion and Gerber baby food units. In 2008, Con - 

sumer Health con tin u ing op er a tions sales rose 7.1% (4% in lo cal cur rency terms) to $5.8 bil lion. There 

was strong growth in emerg ing mar kets, but a fall of 3% in the USA to $1,714 mil lion: sales in the rest of 

the world grew 7% in lo cal cur rency terms to $4,098 mil lion. Mor gan Stan ley an a lysts (Jan u ary 2009) 

pre dict 2009 sales of $6,152 mil lion rising to $7,555 million in 2014. 

OTC: 

Novartis’ OTC busi ness was boosted in 2005 by the ac qui si tion of Bris tol-Myers Squibb’s US and Ca na dian 

OTC prod ucts. The deal in cluded the an al ge sic Excedrin and also al lowed Novartis to sell the prod ucts in 

Latin Amer ica, Eu rope, the Mid dle East, and Af rica, al though 90% of their com bined sales are in the USA. 

In 2008, the OTC busi ness ex panded thanks to con tin ued fo cus on stra te gic brands (such as Voltaren, 

Theraflu, and Otrivin) and ex pan sion in emerg ing mar kets, in clud ing East ern Eu rope and Rus sia 

(Novartis re ports it now has the top po si tion in Rus sia). In the USA, how ever, sales fell which Novartis 

notes re flects changes in con sumer spend ing that have af fected the en tire in dus try. Novartis main tained 

its po si tion as world’s num ber four OTC com pany in 2008. 



An i mal Health: 

Novartis An i mal Health de vel ops and mar kets para siti cides and med i cines for farm and do mes tic an i mals, 

as well as in sect and ro dent con trol prod ucts. Main prod ucts for com pan ion an i mals in clude treat ment for 

atopic der ma ti tis, in tes ti nal par a sites and heartworm con trol, heart fail ure and re nal in suf fi ciency and 

vet er i nary su ture lines. For farm an i mals, the unit mar kets farm fly and par a site con trol prod ucts, 

therapeutic anti-infectives, and vaccines. 

The com pany is ranked num ber six in the An i mal Health in dus try, ac cord ing to Novartis in 2008. In 2008 

growth was driven by the com pan ion an i mal busi ness as the world cri sis in farm ing damp ened growth in 

this mar ket. Sankyo Lifetech ac qui si tion in Ja pan, closed in 2007, strength ened Novartis pres ence in 

com pan ion-an i mal segment. 

CIBA Vi sion: 

The CIBA Vi sion unit mar kets a range of con tact lenses and lens care prod ucts in more than 70 coun tries. 

R&D ef forts have pro duced lenses such as O2OPTIX, high-ox y gen, breath able lenses; Night & Day, 

high-ox y gen ex tended wear lenses that can be worn for up to 30 con tin u ous nights; and Fo cus Dai lies, 

daily dis pos able lenses for help pro vide the clear est, most com fort able vi sion pos si ble. In lens care, CIBA 

Vi sion’s prod ucts in clude AQuify Multi-Pur pose So lu tion/Solo Care Aqua All-In-One So lu tion and Clear 

Care/Aosept Plus per ox ide sys tem. Ac cord ing to Novartis it was sec ond in the world in this area in 2008. 

Growth in the year bene fited from new con tact lenses in the US and other key markets. 

Mis cel la neous 

Vac cines 

Novartis Vac cines is the world’s fifth-larg est vac cines busi ness and the world’s sec ond-larg est man u fac - 

turer of flu vac cines and has im por tant meningococcal, pe di at ric and travel vac cine fran chises. The com - 

pany’s port fo lio of prod ucts in cludes vac cines for in flu enza, men in gi tis, ra bies, tick-borne en ceph a li tis 

(TBE), Haemophilus influenzae B (Hib), po lio, mumps, mea sles and ru bella and diph the ria, tet a nus and 

per tus sis (whoop ing cough). The vac cines busi ness was in cor po rated in 2006 with the ac qui si tion of 

Chiron. The busi ness di vi sion con sists of two units: vac cines and blood test ing busi ness, which re tains the 

Chiron name, ded i cated to pre vent ing the spread of infectious diseases through novel blood-screening 

tools. 

In 2008, Vac cines & Di ag nos tics net sales rose 21.1% to $1.8 bil lion, driven by de liv er ies of the H5N1 

pan demic in flu enza vac cines to the US gov ern ment, sales of com po nents for pe di at ric vac cines and 

steady growth in di ag nos tics. There were, how ever, lower US sea sonal in flu enza vaccine sales. 

A ma jor prod uct in this sec tor is the Fluvirin in flu enza vac cine. Novartis was the first com pany to com - 

mer cially pro duce and mar ket cell cul ture-based vac cines to pre vent in flu enza. The OptaFlu vac cine, 

based on novel cell cul ture tech nol ogy in stead of tra di tional egg-based pro duc tion, was ap proved in Eu - 

rope in 2007. Cell-cul ture based in flu enza vac cines prom ise many ad van tages over egg-based pro duc - 

tion, in clud ing greater re li abil ity and re duced pro duc tion lead time that could be crit i cal in a pan demic. 

This tech nol ogy is con sid ered the most im por tant pro duc tion in no va tion for in flu enza vac cines in over 50 

years. In the USA phase III trials were ongoing in early 2009. 

In 2007, Novartis also re ceived EU ap proval for Focetria, a vac cine for use in a pan demic in flu enza out - 

break. Focetria will be man u fac tured to con tain strains de clared at the time of a pan demic by the World 

Health Or ga ni za tion (WHO). It will also in clude the pro pri etary Novartis adjuvant MF59, which could ex - 

tend sup plies by al low ing for small amounts of vi ral an ti gens to be used in each dose com pared to vac - 



cines with out this ad di tive de signed to in crease ef fi cacy. In Jan u ary 2009 Novartis was awarded a $486 

mil lion grant from the US fed eral agency the HHS to fund a new pan demic flu vac cine man u fac tur ing fa cil - 

ity. The HHS will pro vide money over eight years to sup port de sign, con struc tion, val i da tion and li cens ing 

of the fa cil ity which will make cell-based vac cines. Novartis will pro vide a pre-pan demic sup ply of vac cine 

and en sure ca pac ity to man u fac ture 150 million doses within six months of the declaration of a pandemic. 

Novartis and Intercell es tab lished an al li ance in July 2007 that broad ens Novartis’ vac cines port fo lio. 

Novartis has gained ac cess to over 10 Intercell pro jects in pre clin i cal and early-stage de vel op ment, in - 

clud ing vac cines for pre ven tion of hos pi tal-ac quired in fec tions and other life-threat en ing dis eases, in re - 

turn for an upfront pay ment and eq uity in vest ment to tal ing $364 mil lion. Novartis will as sume 

re spon si bil ity for phase III de vel op ment, man u fac tur ing and com mer cial iza tion for any Intercell projects 

chosen after phase II trials. 

In 2008 Novartis cre ated a new busi ness unit within Pharmaceuticals, Novartis Mo lec u lar Di ag nos tics, to 

lead new ini tia tives in med i cine-re lated di ag nos tics. 



Research Pipeline for Novartis 

R&D Profile 

Compound Code Class Phase 

filgrastim — L3A1 Approved 

vaccine, pandemic influenza, Novartis — J7A1 Approved 

aliskiren + valsartan — C9X, C9D9 Filed 

canakinumab ACZ 885 M1C, R3X, V3X, S1P Filed 

efungumab — J2A, L1X3 Filed 

indacaterol QAB 149 R3A Filed 

vaccine, Japanese encephalitis virus, 

Intercell IC51 J7A9 Filed 

vaccine, meningococcal ACWY, Novartis MenACWY J7A8 Filed 

valsartan + amlodipine + HCTZ — C9D3 Filed 

agomelatine AGO 178 N6A, N5B III 

albinterferon alfa-2b ABF 656 J5B, L3B1 III 

aliskiren + amlodipine — C9X, C8A III 

aliskiren + amlodipine + HCTZ — C9X, C8A, C3A III 

drug delivery system, NexACT, 

terbinafine, Novartis NM 100060 D1A, V7A III 

drug delivery system, oral salmon 

calcitonin, Emisphere/Novartis SMC 021 H4A, V7A III 

drug delivery system, poliglumex 

paclitaxel CT 2103, PG-TXL, CHC 12103 L1C, V7A III 

fingolimod FTY 720 L4A, N7X III 

formoterol + mometasone MFF 258 R3F III 

midostaurin PKC 412, CGP 41251 L1X9, S1X III 

pasireotide SOM 230 L2A9 III 

patupilone EPO 906 L1D III 

tifacogin TFP 561 V3X, J1X9 III 

vaccine, Neisseria meningitidis group B, 

Novartis MenB J7A8 III 

vaccine, pre-pandemic influenza, 

Novartis — J7A1 III 

vadimezan ASA 404, AS 1404 L1X9 III 

antipsychotic AQW 051 N5A9, N7D9 II 

ARB/NEP blocker LCZ 696 C2A, C9C II 

asthma and COPD therapy QAE 397 R3X II 

asthma/COPD therapy QAT 370 R3G II 

cancer therapy AUY 922 L1X9 II 

cannabinoid receptor agonist SAB 378 N7X II 

carbapenem antibiotic PTZ 601, SMP 601, SM 216601 J1P2 II 

cystic fibrosis therapy QAU 145 R7X II 

drug delivery system, indacaterol + 

glycopyrronium bromide QVA 149 R3G, V7A II 

drug delivery system, inhaled 

glycopyrronium bromide NVA 237, AD 237 R7X II 

elinogrel PRT 060128 B1C2, C1D II 

gimatecan ST 1481, CPT 184, LBQ 707 L1X9 II 

glaucoma therapy Y 39983 S1E II 

HCV therapy IDX 184 J5B1 II 

indacaterol + mometasone QMF 149 R3F II 

lucatumumab HCD 122 L1X9 II 

MAb, CSF1, Novartis MCS 110 L1X3 II 



MAb, IL-17A, Novartis AIN 457 A7E, D5B II 

MAb, interleukin-13, Novartis QAX 576 R3X, R7X, R1B II 

mGlu5 receptor antagonist AFQ 056 N4A, N7X, A3F II 

neurokinin 1 and 2 antagonist DNK 333 A3G II 

oral phosphate binder SBR 759 V3G II 

panobinostat LBH 589 L1X9 II 

pegmusirudin SPP 200 C6A, B1E II 

renin inhibitor SPP 635 C9X II 

reverse transcriptase inhibitor IDX 899 J5C3 II 

RSV therapy RSV 604, A 60444 J5B5 II 

sotrastaurin AEB 071 L4A II 

vaccine, HCV epitope-based, Intercell IC41, IC 41, IC 41202 J7A3 II 

vaccine, nicotine withdrawal NIC 002, CYT002-NicQb N7B, J7A9 II 

vaccine, pseudomonas aeruginosa, 

Intercell — J7A9 II 

Alzheimer’s disease therapy CAD 106 N7X, N7D9, J7C I 

anticancer agent AEE 788 L1X4 I 

antiepileptic BGG 492 N3A I 

atherosclerosis therapy APP 018, APL 180 C6A I 

cancer therapy RAF 265 L1X4 I 

COPD therapy QAX 028 R3X I 

dovitinib TKI 258, CHIR 258 L1X4 I 

drug delivery system, human parathyroid 

hormone — M5B9, H4E, V7A I 

glaucoma therapy RKI 983 S1E I 

glaucoma therapy SAD 448 S1E I 

hepatitis C therapy NIM 811, SDZ 811 J5B1 I 

hypertension therapy LCI 699 C2A I 

hypertension therapy VNP 489 C2A I 

MAb, cancer, MorphoSys/Novartis BHQ 880 L1X3 I 

MAb, DR5, Novartis LBY 135 L1X3 I 

multiple sclerosis therapy BAF 312 N7X I 

osteoporosis therapy ATF 936 M5B9 I 

PI3K NVP BEZ235, BEZ 235 L1X9 I 

PI3K inhibitor BGT 226 L1X4 I 

psoriasis therapy AHT 956 D5B I 

psoriasis therapy BCT 194 D5A I 

RA therapy QAL 964 M1C I 

renin inhibitor SPP 1148 C9X I 


S1P receptor agonist KRP 203 L4A I 

spinal cord injury therapy ATI 355 N7X I 

vaccine adjuvant IC31 J7C, L3A9 I 

vaccine, cytomegalovirus, Novartis — J7A9 I 

vaccine, Group B Streptococcus, Novartis — J7A9 I 

vaccine, H pylori, Novartis — J7A9 I 

vaccine, HIV infection, Novartis — J7A9, J5C9 I 

asthma therapy VAK 694 R3X Preclinical 

Bcr-Abl inhibitors, Lilly/Novartis — L1X4 Preclinical 

cell cycle inhibitor AT 9311 L1X9 Preclinical 

HCV NS3/4A protease inhibitors, Idenix — J5B1 Preclinical 

HSP 90 inhibitor HSP 990 L1X9 Preclinical 

inflammatory diseases therapy AVP 28225 L4A, M1C Preclinical 

mitotic kinesin Eg5 inhibitor BQS 481 L1X9 Preclinical 

mitotic kinesin Eg5 inhibitor LCL 161 L1X9 Preclinical 

PI3K inhibitor BKM 120 L1X9 Preclinical 

renin inhibitor SPP 800 C9X Preclinical 

RNA polymerase inhibitor IDX 375 J5B1 Preclinical 

SMO inhibitor LDE 225 L1X9 Preclinical 



vaccine, Borrelia, Novartis — J7A9 Preclinical 

vaccine, Candida, Novartis — J7A9 Preclinical 

vaccine, Chlamydia, Novartis/Intercell — J7A9 Preclinical 

vaccine, Group A Streptococcus, Novartis — J7A9 Preclinical 

vaccine, Group B Streptococcus, Novartis/ 

Intercell — J7A9 Preclinical 

vaccine, influenza, Dynavax — J7A1 Preclinical 

vaccine, Klebsiella, Novartis/Intercell — J7A9 Preclinical 

vaccine, otitis media, Novartis/Intercell — J7C Preclinical 

vaccine, Streptococcus pneumoniae, 

Novartis/Intercell — J7A7 Preclinical 

TLR9 immunomodulatory 

oligonucleotides, Idera/Novartis QAX 935 R3X Discovery 

In Jan u ary 2009, Novartis stated that it had 152 pro jects in clin i cal de vel op ment. R&D ac tiv i ties are fo - 

cused in par tic u lar on car dio vas cu lar and met a bolic dis eases, on col ogy and neu rol ogy as well as re spi ra - 

tory and in fec tious dis eases. Novartis’ pipe line is vast, con tain ing com pounds in many ther a peu tic ar eas. 

In Jan u ary 2009, Novartis re ported that in 2008 it had made 14 reg u la tory sub mis sions for key prod ucts 

and re ceived 10 ap prov als for key prod ucts (in clud ing line ex ten sions for mar keted drugs). Novartis also 

re ports that 25% of its ex plor atory pipe line is now bi o log i cal drugs. In 2008, Novartis invested $7.2 billion 

in R&D, up 12%. 

Sub mis sions for ap proval for key pipe line prod ucts in 2008 in clude, the men in gi tis vac cine Menveo in the 

USA, the new can cer treat ment Afinitor (everolimus) in the USA and Eu rope, for the once daily long-act - 

ing beta ag o nist indacaterol (QAB 149) for COPD in the USA and Eu rope, and the hu man monoclonal 

an ti body to interleukin-1 beta, and ACZ 885, for the treat ment of Cryopyrin-As so ci ated Pe ri odic Syn - 

dromes (CAPS) in the USA and Eu rope. Novartis an tic i pates ap proval in 2009 for Menveo, Afinitor, and 

the Jap a nese en ceph a li tis vi rus vac cine, Ixiaro, which was filed for approval in 2007 in the USA and EU. 

Novartis plans sub mis sions for sev eral new prod ucts in 2009: for fingolimod (FTY 720), which may be - 

come the first oral, once-daily dis ease-mod i fy ing treat ment for pa tients with re laps ing mul ti ple scle ro sis 

(MS), MFF 258, com bi na tion of formoterol and mometasone for COPD, and Albuferon (albinterferon 

alfa-2b) for hepatitis C. 

Novartis faces the pros pect of US ge neric com pe ti tion for its lead ing prod uct, Diovan (valsartan) in Sep - 

tem ber 2012 (ear lier in some other mar kets). It has al ready launched a com bi na tion prod uct, Exforge 

(valsartan + amlodipine) and the renin in hib i tor Tekturna (aliskiren) to bol ster its car dio vas cu lar fran - 

chise. It is also de vel op ing a range of fixed-dose com bi na tion prod ucts in clud ing Diovan plus Tekturna 

(filed in the USA in late 2008), Tekturna plus amlodipine, Exforge plus HCTZ, and Tekturna plus 

amlodipine plus HCTZ. How ever, these prod ucts will not be able to re place the Diovan sales that will be 

lost at pat ent ex piry. Novartis also has sev eral renin in hib i tors in early clin i cal tri als, fol low ing the 2008 

ac qui si tion of Speedel, and a range of other cardiovascular products in early clinical trials. 

In Feb ru ary 2009, Novartis gained a li cense to Portola’s ADP re cep tor an tag o nist, elinogrel, for the 

treat ment and pre ven tion of throm bo sis in pa tients with acute cor o nary syn drome or un der go ing cor o - 

nary in ter ven tion (PCI), and for the sec ond ary pre ven tion of MI and stroke. This is a new area for Novartis 

but one that is be ing ac tively in ves ti gated by sev eral of its peers, but with prod ucts al ready filed for ap - 

proval or in phase III, whereas elinogrel is in phase II tri als. 



Alimentary Tract and Metabolism Agents 

MAb, IL-17A, Novartis AIN 457 A7E, D5B II 

neurokinin 1 and 2 antagonist DNK 333 A3G II 

AIN 457, a monoclonal an ti body against interleukin-17A, was in phase II tri als in 2008 for the treat ment 

of pso ri a sis and Crohn’s dis ease. AIN 457 is also in phase I tri als in Eu rope for the treat ment of pso ri a sis. 

De vel op ment for the in di ca tion of rheu ma toid ar thri tis have been terminated. 

Clin i cal Data: In Jan u ary 2008, a ran dom ized, dou ble-blind, pla cebo-con trolled, par al lel-group, 

proof-of-con cept, phase II study ini ti ated in the USA and Can ada as sess ing the ef fi cacy, safety and 

tolerability of two sin gle in tra ve nous in fu sions of AIN 457 10 mg/kg in 72 pa tients with mod er ate to se - 

vere ac tive Crohn’s dis ease. Pri mary out come mea sures will in clude mean Crohn’s dis ease ac tiv ity in dex 

(CDAI) and sec ond ary out come mea sures will in clude per cent age of pa tients achiev ing re mis sion, main - 

te nance of remission, safety and tolerability. 

DNK 333 is a dual neurokinin 1 and 2 an tag o nist in phase II tri als with Novartis for the treat ment of ir ri ta - 

ble bowel syn drome (IBS). It had been pre vi ously stud ied for the treat ment of rhi ni tis, asthma and pul - 

mo nary ob struc tive dis ease, but de vel op ment in these in di ca tions have been discontinued. 

In Jan u ary 2008, it was re ported that Novartis has com pleted a ran dom ized, dou ble-blind, pla cebo-con - 

trolled, par al lel-group, multicenter, phase II study eval u at ing the ef fi cacy and safety of DNK 333 25 mg 

bid given orally for four weeks in 180 fe male pa tients with di ar rhea-pre dom i nant ir ri ta ble bowel syn - 

drome (IBS-D). Pri mary out come mea sures in cluded weekly re sponse to sat is fac tory re lief as sess ments, 

IBS-re lated ab dom i nal pain/dis com fort and over all IBS-D symp toms. Sec ond ary out come mea sures in - 

cluded oc cur rence and con trol of bowel ur gency, change in stool fre quency, se ver ity of ab dom i nal bloat - 

ing and se ver ity of ab dom i nal pain/discomfort. The trial was completed in October 2007. 

Antineoplastics/Immunomodulating Agents 

filgrastim — L3A1 Approved 

drug delivery system, poliglumex 

paclitaxel CT 2103, PG-TXL, CHC 12103 L1C, V7A III 

fingolimod FTY 720 L4A, N7X III 

midostaurin PKC 412, CGP 41251 L1X9, S1X III 

pasireotide SOM 230 L2A9 III 

patupilone EPO 906 L1D III 

vadimezan ASA 404, AS 1404 L1X9 III 

cancer therapy AUY 922 L1X9 II 

gimatecan ST 1481, CPT 184, LBQ 707 L1X9 II 

lucatumumab HCD 122 L1X9 II 

MAb, CSF1, Novartis MCS 110 L1X3 II 

panobinostat LBH 589 L1X9 II 

sotrastaurin AEB 071 L4A II 

anticancer agent AEE 788 L1X4 I 

cancer therapy RAF 265 L1X4 I 

dovitinib TKI 258, CHIR 258 L1X4 I 

MAb, cancer, MorphoSys/Novartis BHQ 880 L1X3 I 

MAb, DR5, Novartis LBY 135 L1X3 I 

PI3K NVP BEZ235, BEZ 235 L1X9 I 

PI3K inhibitor BGT 226 L1X4 I 

S1P receptor agonist KRP 203 L4A I 

Bcr-Abl inhibitors, Lilly/Novartis — L1X4 Preclinical 

cell cycle inhibitor AT 9311 L1X9 Preclinical 

HSP 90 inhibitor HSP 990 L1X9 Preclinical 



inflammatory diseases therapy AVP 28225 L4A, M1C Preclinical 

mitotic kinesin Eg5 inhibitor BQS 481 L1X9 Preclinical 

mitotic kinesin Eg5 inhibitor LCL 161 L1X9 Preclinical 

PI3K inhibitor BKM 120 L1X9 Preclinical 

SMO inhibitor LDE 225 L1X9 Preclinical 

ZARZIO/FILGRASTIM HEXAL (filgrastim): In Feb ru ary 2009, Novartis gained Eu ro pean ap proval for 

a biosimilar ver sion of filgrastim, a col ony stim u lat ing fac tor, as a ther apy for neutropenia. 

XYOTAX (drug de liv ery sys tem, poliglumex paclitaxel) uti lizes a polyglutamic acid com plex-based, wa - 

ter sol u ble sys tem to de liver paclitaxel. The prod uct, co-de vel oped by orig i na tor Cell Ther a peu tics (USA) 

and Novartis, is in phase III tri als for the treat ment of nonsmall cell lung can cer (NSCLC) and ovarian 

cancer. 

Li cens ing: Novartis ac quired world wide ex clu sive de vel op ment and com mer cial iza tion rights to Xyotax 

from Cell Ther a peu tics in Sep tem ber 2006. In re turn, Cell Ther a peu tics will re ceive up to $270 mil lion in 

prod uct reg is tra tion and sales mile stones. Novartis will also make a $15 mil lion eq uity in vest ment in Cell 

Ther a peu tics. Cell Ther a peu tics will re tain an op tion for co-de tail ing Xyotax in the USA un der the di rec tion 

of Novartis. The clos ing of this trans ac tion is sub ject to an ti trust clear ance and cer tain other con di tions. 

As part of the agree ment, Novartis also has an op tion to de velop and com mer cial ize Cell Ther a peu tics’ 

pixantrone, a topoisomerase II in hib i tor which in ter ca lates DNA, in phase III trial as a therapy for 

aggressive non-Hodgkin’s lymphoma. 

FINGOLIMOD (FTY 720), an immunosuppressant (S1P-R ag o nist), is de rived from a Chi nese cat er pil lar 

fun gus and is be ing de vel oped for the treat ment of au to im mune dis eases, such as mul ti ple scle ro sis 

(MS). Novartis thinks fingolimod has the po ten tial to be come the first oral dis ease-mod i fy ing treat ment 

for MS. It is be ing stud ied in a ma jor phase III pro gram, which has en rolled over 3,000 pa tients world - 

wide. Tri als for use in kid ney trans plant pa tients have been dis con tin ued. Novartis says that a fil ing 

should take place by the end of 2009. Fingolimod has been des ig nated as Or phan Drug in Ja pan. Phase II 

trials in MS in Japan began in 2007. 

In July 2008, Novartis re ported that fingolimod is pro gress ing to ward sub mis sions at the end of 2009, 

and noted that it has the po ten tial to be come the first once-daily oral ther apy for MS. It stated that var i - 

ous tri als are un der way in the larg est phase III pro gram to be con ducted in MS. About 3,200 peo ple with 

MS are en rolled in five tri als world wide, with a com bined 2,300 pa tient-years of ex pe ri ence. The com pany 

noted that in Q2 2008, two in fec tion-re lated in ci dents oc curred among FTY 720 pa tients, in clud ing one 

fa tal ity (dis sem i nated zoster). In for ma tion on these cases was shared with in ves ti ga tors and rel e vant 

health au thor i ties, and re viewed by an in de pend ent Data Safety Mon i tor ing Board. Pa tients in the tri als 

are being notified and studies are progressing as planned. 

In No vem ber 2008, Novartis stated “FTY 720 (fingolimod) has the po ten tial to be the first 

sphingosine-1-phos phate re cep tor (S-1-P) mod u la tor, a new class of ther a peu tics that act on in flam ma - 

tion and may have a di rect ben e fi cial ef fect on the cen tral ner vous sys tem. First re sults from the phase III 

TRANS FORMS trial com par ing this once-daily oral com pound against the once-weekly in ter feron beta-1a 

in jec tion in re laps ing re mit ting MS pa tients are ex pected by early 2009. Reg u la tory sub mis sions are on 

track for the end of 2009 that will in clude com pleted data from the TRANS FORMS and FREE DOMS I tri als 

as well as a sub set of data from the FREE DOMS II trial. A new Phase III trial called INFORMS was started 

in the third quar ter of 2008 in pa tients with pri mary pro gres sive MS, a form of this disease for which there 

is no available treatment.” 

Li cens ing: Fingolimod was li censed-in from Yoshitomi, now part of Mitsubishi Tanabe (Ja pan). It was 

orig i nally de vel oped by Yoshitomi and Taito (Ja pan), in col lab o ra tion with the Na tional Chil dren’s Med i cal 

Cen ter (Ja pan) and Toho Uni ver sity (Ja pan). In 1997, Novartis gained ex clu sive world wide rights out side 

Ja pan, where Mitsubishi Tanabe re tains co-de vel op ment and co-marketing rights. 



Clin i cal Data: In De cem ber 2008 Novartis re ported the first re sults from the TRANS FORMS phase III 

trial which showed that FTY 720 had su pe rior ef fi cacy to a cur rent stan dard of care for pa tients with re - 

laps ing mul ti ple scle ro sis. Pa tients on oral FTY 720 ex pe ri enced sig nif i cantly fewer re lapses than those 

treated with the in ject able med i cine in ter feron beta-1a and the study met its pri mary end point for both 

doses of FTY 720. The an nu al ized re lapse rate at one year for pa tients given FTY 720 0.5 mg was 0.16, 

rep re sent ing a 52% re duc tion com pared to a re lapse rate of 0.33 for in ter feron beta-1a. The FTY 720 

1.25 mg dose also showed a sig nif i cant re duc tion in re lapses with a rate of 0.20 rep re sent ing a 38% re - 

duc tion against in ter feron beta-1a. No sta tis ti cally sig nif i cant dif fer ence was seen be tween the two 

FTY720 doses. Novartis noted “We are en cour aged by the early re sults from TRANS FORMS, which rep re - 

sent a ma jor step to wards de liv er ing an ef fec tive oral treat ment for peo ple with re laps ing-re mit ting MS.” 

The one year head-to-head trial TRANS FORMS (TRial As sess ing in ject able in ter feroN vS FTY720 Oral in 

RrMS) is the first of three stud ies to re port re sults in one of the larg est phase III clin i cal pro grams ever 

con ducted in MS, in volv ing more than 3,400 pa tients around the world. Re sults from the FREE DOMS and 

FREE DOMS II phase III tri als are ex pected at the end 2009 and 2011, re spec tively. Results from the 

INFORMS phase III trial, in patients with primary progressive MS, are expected in 2013. 

Com pe ti tion: An oral treat ment for MS would make a ma jor dif fer ence to treat ing the dis ease. Novartis 

says that sec ond to lim ited ef fi cacy, the need to in ject daily is one of the main ob sta cles to ini ti at ing and 

main tain ing MS ther apy. Fear of nee dles, in con ve nience and in jec tion site re ac tions are all as so ci ated 

with non-com pli ance. For this rea son, other com pa nies are also de vel op ing oral treat ments. An other 

lead ing com pany in the field of MS, Merck KGaA has an oral ver sion of cladribine, Mylinax (li censed 

from Ivax, now part of Teva), in phase III tri als and is also study ing other novel oral treat ments for MS. 

Novartis’ de lay in start ing phase III tri als, orig i nally due to be gin in 2005, means Mylinax has the lead on 

fingolimod. Mylinax en tered a two-year phase III trial in 2005. Merck Serono, the pharma arm of Merck 

KGaA, plans to sub mit oral cladribine tab lets for EMEA and FDA approval in 2009/2010 for the treatment 

of RMS. 

Sales/An a lyst Com ment: Mor gan Stan ley an a lysts (De cem ber 2008) noted that they viewed the re - 

sults from the TRANS FORMS study as pos i tive, since ef fi cacy far ex ceeded their ex pec ta tions. How ever, 

they do note that there are clearly is sues re lated to tox ic ity, with two fa tal her pes in fec tions and three 

cases of mel a noma, but in their opin ion ef fi cacy su pe rior to the cur rent stan dard of care com bined with an 

ad verse event pro file that ap pears com pa ra ble to Tysabri means that FTY 720 stands a good chance of 

gain ing FDA ap proval. As the first oral agent for MS they be lieve it could be ca pa ble of achiev ing rev e nues 

of more than $2 bil lion, but con sen sus re sides in the $500 mil lion to $1 bil lion range. “As a once-daily pill 

for a fa tigued pa tient pop u la tion cur rently de pend ent on in ject able ther a pies, there is likely to be sig nif i - 

cant pa tient de mand, as sum ing the ad verse event pro file is rea son able,” note the an a lysts. The an a lysts’ 

ma jor con cern is the mel a noma ad verse events, but they note that the longer term FREEDOMS study 

reporting in 2009 could better characterize this risk. 

Cowen & Co an a lysts (Au gust 2008) fore cast ini tial sales of $50 mil lion in 2010 ($450 mil lion in 2013). 

They are of the opin ion that adop tion will be slow be cause of safety con cerns. 

MIDOSTAURIN (PKC 412), a pro tein kinase C in hib i tor and an an a logue of staurosporine, en tered piv - 

otal phase III tri als in the sec ond quar ter of 2008. The trial is eval u at ing the po ten tial sur vival ben e fit of 

midoastaurin in com bi na tion with che mo ther apy com pared to the use of che mo ther apy alone in treat ing 

pa tients with acute myeloid leu ke mia (AML). Stud ies have also been re ported in co lon, lung and breast 

can cer and CLL. It may also have po ten tial in di a betic retinopathy and other ischemic retinopathies, 

choroidal neovascularization due to macular de gen er a tion, oc u lar histoplasmosis and other dis eases. 

Stud ies have dem on strated that midostaurin is able to com bat re sis tant tu mors, and it could be an al ter - 

na tive to Glivec (imatinib) in GIST pa tients or used in com bi na tion with it. Novartis forecasts filing for 

AML in 2011. 



Clin i cal Data: In Au gust 2008, IMS R&D Fo cus re ported that a US ran dom ized, dou ble-blind, pla - 

cebo-con trolled phase III trial of in duc tion che mo ther apy (daunorubicin/cytarabine) and con sol i da tion 

che mo ther apy (high-dose cytarabine) plus midostaurin or pla cebo has ini ti ated in the USA in ap prox i - 

mately 514 newly di ag nosed pa tients with FLT3 mu tated acute myeloid leu ke mia (AML). The pri mary 

end point of the trial is to de ter mine over all sur vival. Sec ond ary out come mea sures in clude: re sponse 

rate, event-free sur vival, dis ease-free sur vival and dis ease-free sur vival one year af ter completion of the 

planned continuation phase. 


2012 ($75 mil lion in 2013). 

PASIREOTIDE (SOM 230), a somatostatin an a logue, is in phase III tri als. It has po ten tial in the treat - 

ment of acromegaly, carcinoid syn drome, Cush ing’s dis ease and gastroenteropancreatic (GEP) 

neuroendocrine tu mors. Cush ing’s dis ease is a rare dis or der char ac ter ized by ex ces sive ex cre tion of the 

hor mone cortisol from a pi tu itary adenoma (tu mor), a con di tion for which there is no approved medical 

therapy. 

In No vem ber 2007, Novartis ini ti ated a multicenter, ran dom ized, blinded phase III study in the USA to 

as sess the safety and ef fi cacy of long-act ing re lease pasireotide ver sus long-act ing re lease octreotide in 

330 pa tients with ac tive acromegaly. Pri mary out come mea sures will in clude mean growth hor mone lev - 

els and in su lin like growth fac tor-1 (IGF-1) levels. 

Novartis plans to file a NDA for the treat ment of re frac tory/re sis tant carcinoid syn drome in 2010 and for 

the treat ment of acromegaly in 2011. 


2011 ($100 mil lion by 2013). 

PATUPILONE (EPO 906 or epothilone B) is an epothilone microtubule poly mer iza tion pro moter and a 

depolymerization in hib i tor in de vel op ment for the treat ment of solid tu mors. The com pound en tered 

phase III tri als in the USA in 2005 for po ten tial use in the treat ment of ovar ian can cer. How ever, it has ex - 

pe ri enced un ex pect edly slow pa tient ac crual for this trial, de lay ing sub mis sion. A pro to col amend ment 

has been made and the num ber of cen ters ex panded. Phase II tri als in colorectal can cer, breast can cer, 

re nal cell car ci noma and non-small cell lung can cer are also ongoing in the USA and Europe. 

Epothilones are macrolides, pro duced by myxobacteria, that have the abil ity to in duce microtubule for - 

ma tion and sta bi li za tion, ar rest ing the pro gres sion of the cell cy cle and in duc ing apoptosis. EPO 906 is un - 

der in ves ti ga tion as an in tra ve nous for mu la tion. Novartis has fore cast a first filing in 2010. 

Clin i cal Data: Phase II re sults for patupilone were pre sented at the Amer i can So ci ety of Clin i cal On col - 

ogy An nual Meet ing in June 2008. In this US trial, patupilone was as sessed in 22 pa tients with breast can - 

cer brain metastases pro gress ing or re cur ring af ter whole brain ra di a tion ther apy. The agent was well 

tol er ated. No ther apy-re lated grade 4 or 5 ad verse events were ob served. Di ar rhea (71% of pa tients) 

was the most com mon tox ic ity re ported. Fa tigue (63%), nau sea (45%), an orexia (22%), sen sory neu - 

rop a thy (26%) and pain/head ache (27%) were also re ported. Three-month CNS pro gres sion-free sur - 

vival was 32% (95%, CI 11-53%). Three pa tients achieved par tial re sponse, two pa tients had sta ble 

dis ease and eleven had pro gres sive dis ease. Four pa tients are await ing assessment. Accrual in this trial is 

still ongoing. 

Sales/An a lyst Com ment: Cowen & Co an a lysts (au gust 2008) fore cast ini tial sales of $50 mil lion in 

2011 ($100 mil lion by 2013) 



VADIMEZAN (ASA 404) is an an a logue of flavone ace tic acid with po ten tial for use in com bi na tion with 

stan dard che mo ther apy in pa tients with var i ous can cers. Vadimezan was orig i nally de vel oped by 

Antisoma (UK), which li censed it to Novartis in 2007. 

In April 2008, Antisoma stated that its de vel op ment part ner, Novartis, has be gun a ran dom ized, dou - 

ble-blind, pla cebo-con trolled, in ter na tional phase III trial of ASA 404, com bined with first-line che mo - 

ther apy, in the treat ment of nonsmall cell lung can cer (NSCLC). This study, des ig nated AT TRACT-1, will 

en roll 1200 pa tients who will be ran dom ized 1:1 to re ceive ei ther ASA 404 1800 mg/m2 plus che mo ther - 

apy (carboplatin/paclitaxel) or pla cebo plus the same che mo ther apy as a con trol. Over all sur vival will be 

the pri mary end point. Sec ond ary end points in clude sur vival in the squamous and non-squamous pa tient 

sub groups. Pend ing suc cess ful re sults, Antisoma ex pects to submit regulatory applications in 2011. 

In Au gust 2008, Antisoma an nounced sur vival data from its phase II study of vadimezan in hor mone-re - 

frac tory pros tate can cer, in which pa tients were ran dom ized to re ceive ei ther 1,200mg/m2 vadimezan 

plus the che mo ther apy drug docetaxel or a con trol treat ment of docetaxel alone. The haz ard ra tio ex - 

press ing the rel a tive risk of death in the vadimezan and con trol groups fa vored the vadimezan group. Me - 

dian sur vival in the two groups was sim i lar at 17.0 and 17.2 months re spec tively, while two-year sur vival 

was 33% with vadimezan and 23% in the con trol group. Pre vi ously re ported find ings from the same trial 

have shown higher tu mor re sponse rates and mark edly higher PSA re sponse rates in patients receiving 

vadimezan. 

Li cens ing: In 2007, Antisoma signed an ex clu sive global li cens ing deal with Novartis re lat ing to 

vadimezan. Un der the terms of the deal, Novartis is re spon si ble to fund and con duct all fu ture de vel op - 

ment of vadimezan, as well as to fund the out stand ing costs of the phase II tri als be ing com pleted by 

Antisoma. Antisoma is el i gi ble to re ceive to tal upfront, de vel op ment, reg u la tory and sales-re lated mile - 

stone pay ments of $890 mil lion, de pend ing on the suc cess ful de vel op ment and mar ket ing of vadimezan 

and backup prod ucts in mul ti ple in di ca tions. Ad di tion ally, vadimezan is ap proved and com mer cial ized, 

Antisoma will re ceive roy al ties on sales; Antisoma will have an option to co-market in the USA. 


2012 ($100 mil lion in 2013). 

AUY 922 is a syn thetic Hsp90 in hib i tor, be ing de vel oped by Novartis and Vernalis for the po ten tial treat - 

ment of can cer. In 2007, Novartis ini ti ated a phase I/II trial of AUY 922 in the treat ment of solid ma lig - 

nan cies; the phase II ex ten sion arm of this trial will in clude pa tients with breast can cer. In late 2008, 

Novartis be gan the phase I part of an open-la bel phase I/II trial of iv AUY 922 in com bi na tion with 

bortezomib with or with out dexa meth a sone in re lapsed or refractory multiple myeloma. 

GIMATECAN (LBQ 707/ST 1481) is a camptothecin an a logue (DNA topoisomerase in hib i tor), orig i nally 

de vel oped by Sigma-Tau (It aly). In 2003, Novartis gained world wide de vel op ment and com mer cial iza - 

tion rights to gimatecan from Sigma-Tau. Un der the terms of the deal, Sigma-Tau re tains co-mar ket ing 

rights in It aly and will re ceive an upfront pay ment and de vel op ment mile stone pay ments from Novartis 

as well as roy al ties on world wide sales of the prod uct. In 2005, it was re ported to be un der go ing phase II 

tri als in the USA for the treat ment of pa tients with re cur rent or re frac tory ma lig nant glioma. Novartis ex - 

pects to file for approval in the USA in or after 2011. 

In May 2007, Novartis ini ti ated a safety/ef fi cacy phase I trial of gimatecan in Ja pan for the po ten tial treat - 

ment of solid tu mors. The study is eval u at ing gimatecan ad min is tered orally twice per week ev ery 28 

days to Jap a nese pa tients with ad vanced solid tu mors. Novartis plans to en roll 34 pa tients and pri mary 

out come mea sures in clude the safety and tolerability as sessed by ad verse events char ac ter iza tion of the 

pharmacokinetic pro file of gimatecan antitumor ac tiv ity as sessed by Re sponse Eval u a tion Criteria in Solid 

Tumors (RECIST). 




2012 ($100 mil lion in 2013). 

LUCATUMUMAB (HCD 122) is a fully hu man anti-CD40 monoclonal an ti body with po ten tial in many 

B-cell ma lig nan cies. Pre clin i cal stud ies showed that HCD 122 has greater cytotoxicity against B-cells than 

Roche’s MabThera (rituximab). Lucatumumab is in phase I tri als in the USA for the treat ment of mul ti ple 

myeloma. A phase I trial, eval u at ing it as a ther apy for chronic lymphocytic leu ke mia, was dis con tin ued in 

July 2008 be cause of lim ited patient enrollment. 

In April 2008, Novartis and its part ner XOMA (USA) ini ti ated a phase I/II trial of lucatumumab in adults 

with non-Hodg kin’s lym phoma or Hodg kin’s lym phoma. Dur ing this open-la bel, dose-es ca lat ing study, 

up to 50 pa tients who have re ceived at least two prior ther a pies will re ceive the monoclonal in tra ve nously 

once a week for four weeks. The safety, ac tiv ity and high est tol er ated dose will be eval u ated. This study is 

be ing con ducted at sites in the USA, Aus tra lia, Bel gium, France, Germany and Italy. 

Li cens ing: Lucatumumab is be ing co-de vel oped by Novartis and XOMA. Novartis ob tained rights to 

lucatumumab via the 2005 pur chase of Chiron. In 2004, Chiron and Xoma agreed to jointly re search, de - 

velop and com mer cial ize an ti body prod ucts for the treat ment of can cer. In No vem ber 2008 the deal with 

XOMA that cov ers HCD 122 and five other pro jects was re struc tured as fol lows: Novartis will make an 

upfront pay ment of $6.2 mil lion; fully fund all fu ture R&D ex penses; pay po ten tial mile stones of up to $14 

mil lion and dou ble-digit roy alty rates for two on go ing prod uct pro grams, in clud ing HCD 122; and pro vide 

XOMA with op tions to de velop or re ceive roy al ties on four ad di tional pro grams that are pend ing se lec tion. 

Novartis now has con trol over the HCD 122 pro gram and one other on go ing pro gram, as well as the right 

to ex pand the de vel op ment of these programs to additional indication outside of oncology. 


2012 ($75 mil lion in 2013). 

MCS 110, a monoclonal an ti body tar geted to col ony stim u lat ing fac tor-1, was in phase I/II tri als for the 

treat ment of can cer in 2008 in the USA in pa tients with pros tate can cer and bone metastases. 

PANOBINOSTAT (LBH 589) is an anticancer agent that in hib its histone deacetylase and in duces the 

p21 tu mor sup pres sor gene. It has po ten tial as a ther apy for both solid and he ma to log i cal tu mors. The 

com pound is be ing in ves ti gated in the treat ment of re frac tory cu ta ne ous T-cell lym phoma (CTCL), 

chronic myeloid leu ke mia (CML) and mul ti ple myeloma. Novartis is de vel op ing both oral and in tra ve nous 

for mu la tions of panobinostat. A reg u la tory submission is planned for 2009. 

Novartis ini ti ated a phase II trial of oral panobinostat in 2007 to eval u ate the safety and ef fi cacy of the 

agent in adult pa tients with re frac tory chronic myeloid leu ke mia (CML) pre vi ously treated with at least 

two BCR-ABL ty ro sine kinase in hib i tors. Panobinostat is also in phase II tri als for mul ti ple myeloma. In 

2006, a phase I trial of the agent was ini ti ated in Ja pan for the treat ment of ad vanced solid tu mors and 

CTCL. A phase I trial of LBH 589 alone and in com bi na tion with docetaxel and pred ni sone ini ti ated in the 

USA in 2006 in the treat ment of hor mone-re frac tory pros tate can cer. In Feb ru ary 2008, a phase Ib trial of 

iv panobinostat with docetaxel and pred ni sone in pa tients with hor mone-re frac tory pros tate can cer was 

ini ti ated in Can ada and the USA. Novartis in tends to ex plore the use of panobinostat in other challenging 

malignancies. 

Clin i cal Data: At the Amer i can So ci ety of Clin i cal On col ogy An nual Meet ing 2008 (30 May-3 June 2008), 

phase II data on panobinostat in CTCL were re ported. In this Eu ro pean, Aus tra lian and US phase II trial in 

pa tients with re lapsed/re frac tory cu ta ne ous T-cell lym phoma (CTCL), 83 pa tients have been treated to 

date with ei ther oral panobinostat 20 mg alone or oral bexarotene, prior to panobinostat. The agent was 

well tol er ated. Among the 83 pa tients evaluable for safety, the most com mon ad verse events were di ar - 

rhea (44.6% of pa tients; 4.8% with grade 3 and 4), thrombocytopenia (42.2% of pa tients; 13.3% with 



grade 3 and 4), nau sea (31.3% of pa tients; 1.2% with grade 3 and 4), fa tigue (26.5% of pa tients; 2.4% 

with grade 3 and 4), pru ri tus (25.3% of pa tients; 3.6% with grade 3 and 4), asthenia (19.3% of pa tients; 

3.6% with grade 3 and 4) and ab dom i nal pain (18.1% of pa tients; 1.2% with grade 3 and 4). 

Thrombocytopenia, di ar rhea, nau sea and fa tigue were the most com mon ad verse events pos si bly re - 

lated to panobinostat and thrombocytopenia was the most com mon grade 3-4 ad verse event pos si bly re - 

lated to the agent. Eight pa tients had re sponse as as sessed with a com pos ite of the mod i fied 

Se ver ity-Weighted As sess ment Tool (mSWAT); eight pa tients had re sponse with mSWAT plus CT scan 

and 11 pa tients had re sponse with PGA (peak ground ac cel er a tion). The me dian time to response was 57 

days and 21 patients experienced improvement in pruritus. 

At the 20th EORTC-NCI-AACR Sym po sium on Mo lec u lar Tar gets and Can cer Ther a peu tics (Oc to ber 

2008) in Geneva, Swit zer land, Novartis pre sented pre clin i cal data for panobinostat. In SCLC and NSCLC 

cell lines, panobinostat in hib ited pro lif er a tion at low nanomolar con cen tra tions (IC50 5-85 nM). In SCLC 

tu mor bi op sies, treat ment with panobinostat re sulted in in creased histone acetylation, p21 ex pres sion 

upregulation and caspase ac ti va tion. In xenograft tu mor mod els of SCLC, panobinostat in duced sig nif i - 

cant tu mor re gres sion; in NSCLC tu mor mod els it in hib ited tu mor growth. Ad di tive antitumor ef fects were 

dem on strated in an H69 SCLC xenograft tu mor model when panobinostat was combined with etoposide. 


2010 ($80 mil lion by 2013). 

SOTRASTAURIN (AEB 071) is a T-cell ac ti va tion in hib i tor that tar gets pro tein kinase C (PKC), for the 

pre ven tion of trans plant re jec tion. Phase II tri als were on go ing in Eu rope in 2008. It aims to be come the 

first oral treat ment that in hib its T-cell ac ti va tion since the in tro duc tion of calcineurin in hib i tors. T-cell ac ti - 

va tion is an early step in au to im mune dis eases such as pso ri a sis and is also es sen tial for the re jec tion of 

trans planted or gans. AEB 071 blocks a path way crit i cal to T-cell ac ti va tion and has shown prom ise in or - 

gan trans plan ta tion as well as in au to im mune dis or ders. It has shown im prove ments in psoriatic skin le - 

sions in an early proof-of-con cept study and has en tered started phase II trials for organ transplantation 

(prevention of graft rejection). 

Clin i cal Data: At the 231st Amer i can Chem i cal So ci ety na tional meet ing, in March 2006, Novartis pre - 

sented data on AEB 071 for the pre ven tion of trans plant re jec tion. In pre clin i cal stud ies the agent in hib - 

ited T-cell ac ti va tion but not T-cell pro lif er a tion, as well as in hi bi tion of NF-kB sig nal ing path way, 

immunosuppressive ef fect and dose-de pend ent in hi bi tion of lymph node swell ing. AEB 071 was well tol - 

er ated in a phase I trial in healthy volunteers in doses up to 500mg. 


2012 ($50 mil lion in 2013). 

AEE 788, a dual in hib i tor of epi der mal growth fac tor re cep tors (EGFR) and vas cu lar en do the lial growth 

fac tor re cep tors (VEGFR), was in phase I tri als in 2008 for use in a va ri ety of solid tu mors. Novartis does 

not an tic i pate a fil ing for reg u la tory approval before 2011. 

RAF 265 is a small-mol e cule in hib i tor of mu tant B-Raf and VEGFR kin ases in phase I tri als for mel a noma. 

It has dem on strated po tent anti-tu mor ac tiv ity in pre clin i cal mod els of mu tant B-Raf. Novartis ob tained 

RAF 265 via the 2005 pur chase of Chiron. In 2008, Novartis stated that it was still in phase I trials. 

DOVITINIB (TKI 258) is an oral VEGFR ty ro sine kinase in hib i tor. It is in phase I tri als in var i ous can cers, 

in clud ing mel a noma, and in late 2008 a phase I was be gun in met a static re nal cell car ci noma (mRCC). 

De vel op ment in AML and mul ti ple myeloma was ter mi nated in 2007. Pre clin i cal stud ies showed that 

dovitinib has di rect ac tiv ity against tu mor cells and against de vel op ment of tu mor vasculature. Novartis 

ob tained dovitinib via the 2005 acquisition of Chiron. 



Clin i cal Data: Novartis pre sented phase I data for dovitinib at the Amer i can So ci ety of Clin i cal On col ogy 

An nual Meet ing in June 2008. In this US trial con ducted in 27 pa tients with ad vanced mel a noma, the 

max i mum tol er ated dose was de ter mined as 400 mg po daily. There were no dose-lim it ing tox ic i ties be - 

low this dose level. The most com mon ad verse events re ported were nau sea, di ar rhea, fa tigue, el e vated 

al ka line phosphatase lev els, el e vated tri glyc er ides and an orexia. One pa tient treated with 200 mg 

dovitinib had sta ble dis ease for nine months; one pa tient given 300 mg dovitinib was sta ble for 3.5 

months; five pa tients treated with 400 mg were sta ble for four months, two of which for more than four 

months, one for five months and one for six months; two pa tients given 500 mg had sta ble dis ease for 

four and six months, re spec tively. En roll ment of 20 patients at the maximum tolerated dose has been 

initiated. 


2012 ($75 mil lion in 2013). 

BHQ 880, an anti-DKK1 (Dickkopf) monoclonal an ti body with po ten tial in the treat ment of solid tu mors, 

is be ing de vel oped by Novartis and MorphoSys. BHQ 880 is in phase I tri als. The an ti body was gen er ated 

us ing MorphoSys’ HuCAL GOLD tech nol ogy. A phase I trial of the an ti body be gan in Sep tem ber 2007 in 

Ger many and Swit zer land. MorphoSys and Novartis es tab lished a col lab o ra tion to de velop an ti - 

body-based ther a pies for a range of dis eases in 2004; the deal was ex panded to in clude a greater 

number of antibody projects in 2006. 

Clin i cal Data: At the Amer i can As so ci a tion for Can cer Re search An nual Meet ing 2008 (April 2008), 

Novartis and MorphoSys pre sented pre clin i cal data for BHQ 880. The an ti body was eval u ated in mouse 

mod els of tu mor-in duced osteolytic dis ease. BHQ 880 pro tected against tu mor-in duced bone loss in an 

osteolytic MDA-MB-231 breast tu mor model that ex presses high lev els of DKK1 and an MMIS mul ti ple 

myeloma model that ex presses low lev els of DKK1. The pro tec tive ef fect of the an ti body was greater in 

the model with high DKK1 expression. 

LBY 135 is a monoclonal an ti body ag o nist tar get ing DR5, which mim ics the ac tion of TRAIL and in duces 

the apoptosis path way. Ac tiv ity has been dem on strated in mul ti ple tu mors. It is un der go ing a two-arm 

phase I study in ad vanced solid tu mors: arm one as a sin gle agent and arm two in com bi na tion with che - 

mo ther apy in advanced colorectal cancer. 

Clin i cal Data: At the Amer i can So ci ety of Clin i cal On col ogy An nual Meet ing 2008 (30 May-3 June 2008), 

re sults from a Eu ro pean two-arm phase I trial of Novartis’ LBY 135 in 56 pa tients with ad vanced solid tu - 

mors were re ported. Pa tients re ceived ei ther LBY 135 alone (arm 1) or in com bi na tion with capecitabine 

(arm 2). In this trial, LBY 135 was well tol er ated as sin gle agent and in com bi na tion with capecitabine at 

doses up to 20 mg/kg. No dose-lim it ing tox ic i ties (DLTs) were ob served in arm 1 and two grade 3 DLTs 

were re ported in arm 2: mucositis at 1 mg/kg and co li tis at 20 mg/kg. The most fre quent (at least 25% 

in ci dence) ad verse events (AEs) re ported, mostly grade 1 or 2, in cluded hypotension, fa tigue and nau sea 

in arms 1 and 2, and vom it ing, py rexia, dyspnea, di ar rhea, ab dom i nal pain and con sti pa tion in arm 2. 

Fre quent AEs (15%) con sid ered as pos si bly treat ment-re lated in cluded hypotension and nau sea in arms 

1 and 2, and ane mia, fa tigue, di ar rhea, hand foot syn drome, mucositis and vom it ing in arm 2. Grade 3 

AEs con sid ered as pos si bly treat ment-re lated were ane mia in arm 1, and ane mia, co li tis, di ar rhea, fa - 

tigue and mucositis in arm 2. LBY 135 ex po sure (AUC) was dose pro por tional with half-life eval u ated 

around ten days. Sat u ra tion of an ti gen sink was reached at dose lev els greater than 3 mg/kg. 

Immunogenicity was de tected in 13 out of 51 pa tients (25%); five of them had re duced ex po sure on re - 

peat dos ing. In arm 1, 14 out of 32 pa tients (in clud ing six pa tients with me so the li oma) re ceived more 

than four cy cles of treat ment. One pa tient (sar coma) had a mi nor re sponse and two pa tients (one 

NSCLC, one pros tate can cer) had de creases in tu mor mark ers of 50% and 40%, re spec tively. In arm 2, 

one pa tient (colorectal can cer) had a par tial re sponse (PR), one pa tient (ovar ian can cer) had a met a bolic 

(PET) PR, and four patients (two ovarian cancer, one colorectal cancer, one pancreatic cancer) had 

decreases in tumor markers of 60-73%. 




2012 ($75 mil lion in 2013). 

NVP BEZ235/BEZ 235 is small-mol e cule phosphoinositide-3 kinase (PI3K) in phase I tri als tar get ing 

pa tients with ad vanced breast can cer, glioma and pros tate can cer. Novartis ob tained the agent via the 

ac qui si tion of Chiron in 2005. 

Clin i cal Data: At the Amer i can As so ci a tion for Can cer Re search An nual Meet ing 2007 (14-18 April 

2007), the MD An der son Can cer Cen ter (USA) pre sented pre clin i cal data for NVP BEZ235. In vi tro, NVP 

BEZ235 in hib ited the growth of glioma cell lines with an IC50 of low nM con cen tra tion. In vivo, 

xenografted mice treated orally with NVP BEZ235 (25 mg/kg daily for four weeks) showed in creased sur - 

vival (p less than 0.05). No tox ic ity, as as sessed by glu cose lev els and weight mea sure ments, was 

observed at this dose. 

BGT 226, an in hib i tor of phosphoinositide 3-kinase (PI3K) and mam ma lian tar get of rapamycin (mTOR), 

was in the phase I part of a phase I/II trial in late 2008 for the treat ment of can cer. 

KRP 203, an orally-ac tive sphingosine-1-phos phate (S1P) re cep tor ag o nist, is in phase I tri als with orig i - 

na tor Kyorin (Ja pan) in 2008 for use in trans plant re jec tion and graft ver sus host disease. 

Li cens ing: In 2006, Kyorin granted Novartis a world wide ex clu sive li cense to de velop and com mer cial ize 

KRP 203 for trans plan ta tion in di ca tions and ex clu sive rights to KRP 203 in the treat ment of au to im mune 

dis eases world wide ex clud ing Ja pan, South Ko rea, China and Tai wan. Novartis re ported in 2008 that KRP 

203 was in ex plor atory phase stud ies for multiple sclerosis. 

BCR-ABL KINASE IN HIB I TORS were in de vel op ment in 2008 with li censee SGX (USA) and Novartis 

for the treat ment of drug re sis tant chronic myelogenous leu ke mia (CML). SGX’s oral bcl-abl in hib i tors, 

gen er ated us ing the com pany’s pro pri etary FAST tech nol ogy plat form, have po ten tial as monotherapies 

in the sec ond-line treat ment of re frac tory or re lapsed CML, and in com bi na tion with other drugs in the 

first-line treat ment of CML. Lilly (USA) acquired SGX in August 2008. 

Li cens ing: Un der the terms of the deal, signed in March 2006, SGX will re ceive from Novartis $25 mil lion 

in upfront pay ments and the pur chase of SGX com mon stock. To tal pay ments by Novartis to SGX, in clud - 

ing a min i mum of two years of re search fund ing and suc cess-based mile stones, but ex clud ing roy al ties, 

may ex ceed $515 mil lion. SGX will be re spon si ble for pre clin i cal de vel op ment of a lead can di date, fil ing an 

IND with the FDA, and con duct ing an ini tial phase I trial; Novartis will be re spon si ble for fur ther clin i cal 

eval u a tion and com mer cial iza tion of the com pound. SGX will re ceive roy al ties from prod ucts that reach 

the mar ket. SGX re tains an op tion to co-com mer cial ize on col ogy products generated under the 

collaboration, in the USA. 

The deal was mod i fied in Sep tem ber 2007. SGX has ob tained the rights to de velop and com mer cial ize 

one of the can di dates, SGX 393, out side of the col lab o ra tion, sub ject to a re ac qui si tion right of Novartis 

that is ex er cis able at a fu ture date. The amend ment to the agree ment also gives Novartis re spon si bil ity 

for the se lec tion of all fu ture de vel op ment can di dates and for the clin i cal de vel op ment of ad di tional com - 

pounds from the col lab o ra tion. The financial terms of the deal remained unchanged. 

AT 9311: Astex Ther a peu tics (UK, for merly Astex Tech nol ogy) and Novartis are de vel op ing AT 9311, a 

cell cy cle in hib i tor, for the po ten tial treat ment of can cer. Pre clin i cal stud ies were un der way in the UK in 

2006. 

Li cens ing: In 2005, Astex Ther a peu tics granted Novartis an ex clu sive world wide li cense to AT 9311. 

Astex Ther a peu tics has the op tion to ac quire US co-com mer cial iza tion rights. Novartis also ac quired an 

op tion to gain rights to an other Astex cell; cy cle in hib i tor in R&D, AT 7519 (in phase I tri als). At the 

Amer i can So ci ety of Clin i cal On col ogy An nual Meet ing 2008, re sults from a US and UK dose es ca la tion 



phase I trial of AT 7519 in pa tients with re frac tory solid tu mors with ad e quate bone mar row, hepatic and 

renal function, were reported. 

HSP 990, a heat shock pro tein 90 in hib i tor, was in pre clin i cal stud ies in 2008 for the treat ment of can cer. 

Clin i cal tri als are ex pected to be gin in 2009. 

AVP 28225 is a lead can di date re sult ing from a col lab o ra tion of Novartis and Avanir (USA) on the de vel - 

op ment of orally ac tive small mol e cules that in hibit macrophage mi gra tion in hib i tory fac tor (MIF), as po - 

ten tial ther a pies for in flam ma tory dis eases such as ar thri tis. Pre clin i cal stud ies of a se ries of agents are 

on go ing in Swit zer land. AVANIR part nered this pro gram with Novartis in 2005; in March 2007, Novartis 

as sumed all con tin u ing re search and development activities for the program. 

Li cens ing: Avanir signed a re search, de vel op ment and com mer cial iza tion agree ment with Novartis in 

2005 to de velop orally ac tive small mol e cules that in hibit macrophage mi gra tion in hib i tory fac tor (MIF) as 

po ten tial ther a pies for in flam ma tory dis eases. Un der the terms of the agree ment, Avanir was el i gi ble to 

re ceive over $200 mil lion in com bined upfront and mile stone pay ments. Avanir would re ceive in creas ing 

roy al ties on world wide sales of any prod uct re sult ing from the al li ance. Avanir would also re ceive re search 

fund ing of up to $2.5 mil lion per year for up to four years. Both com pa nies were to con trib ute ex per tise 

and in tel lec tual prop erty, and Novartis would be re spon si ble for prod uct de vel op ment ex penses. Novartis 

is to as sume all con tin u ing re search and de vel op ment ac tiv i ties re lat ing to the ad vance ment to wards clin - 

i cal de vel op ment of AVP 28225, the lead can di date. Avanir is to re ceive a mile stone pay ment if AVP 

28225 reaches the next stage of development and is eligible to receive additional milestones through 

clinical development. 

BQS 481, mi totic kinesin Eg5 in hib i tor, was in pre clin i cal stud ies in 2008 for the treat ment of can cer. 

Clin i cal tri als are ex pected to be gin in 2009. 

LCL 161, an in hib i tor of IAP (in hib i tor of apoptosis), was in pre clin i cal stud ies in 2008 for the treat ment of 

can cer. Clin i cal tri als are ex pected to begin in 2009. 

BKM 120, an in hib i tor of phosphoinositide 3-kinase (PI3K), was in pre clin i cal stud ies in late 2008 for the 

treat ment of can cer. 

LDE 225, a SMO in hib i tor, was in pre clin i cal stud ies in 2008 for the treat ment of can cer. Clin i cal tri als are 

ex pected to be gin in 2009. 

Blood and Blood-Forming Organ Agents 

elinogrel PRT 060128 B1C2, C1D II 

ELINOGREL, an ADP re cep tor an tag o nist, for the pre ven tion and treat ment of throm bo sis in pa tients 

with acute cor o nary syn drome (ACS) or un der go ing percutaneous cor o nary in ter ven tion (PCI), and for 

the sec ond ary pre ven tion of myo car dial in farc tion and stroke, was in phase II de vel op ment in 2009 with 

orig i na tor Portola (USA). Oral and iv for mu la tions of the agent are be ing de vel oped. Phase II tri als are on - 

go ing of an iv for mu la tion in pa tients ex pe ri enc ing ST-seg ment el e va tion myo car dial in farc tion (STEMI) 

in the USA and Eu rope (be gun in De cem ber 2007) and of elinogrel in com par i son with clopidogrel in the 

USA in 800 pa tients un der go ing non-ur gent PCI, be gun in De cem ber 2008 and known as IN NO VATE-PCI. 

Data from Portola’s phase I and phase IIa tri als have showed elinogrel to be well tol er ated and have pro - 

duce pre dict able, dose-de pend ent platelet in hi bi tion. Elinogrel is also re ported to have a rapid on set of 

ac tion and be re vers ible. Clin i cal tri als are planned in pa tients with acute cor o nary syn dromes (ACS) and 

more broadly in patients with a prior heart attack or stroke, and those with peripheral vascular disease. 



Li cens ing: In Feb ru ary 2009, Novartis gained the ex clu sive world wide rights to elinogrel from Portola 

Pharmaceuticals (USA). Novartis will have re spon si bil ity for phase III tri als, man u fac tur ing and com mer - 

cial iza tion of elinogrel. Dr Trevor Mundel, Global Head of De vel op ment at Novartis noted that “Elinogrel is 

a novel com pound with at trib utes that have the po ten tial to of fer clin i cal ben e fits over cur rently ap proved 

antiplatelet ther a pies. Elinogrel will fur ther di ver sify our car dio vas cu lar pipe line and we hope it will prove 

to be a strong ad di tion to our port fo lio.” Novartis will make an upfront pay ment of $75 mil lion to Portola 

and will share with Portola the costs of the on go ing phase II tri als. Portola will also be el i gi ble for ad di tional 

pay ments based on achiev ing de fined de vel op ment and com mer cial iza tion mile stones and would also re - 

ceive roy al ties on fu ture sales. In ad di tion, Portola has an op tion to co-pro mote elinogrel in the US in the 

hos pi tal and spe cialty mar kets and an op tion to co-fund phase III clin i cal trials and other development 

activities in return for additional royalties. 

Com pe ti tion: The gold-stan dard treat ment in this area is Bris tol-Myers Squibb’s Plavix (clopidogrel) 

which is in di cated to pre vent atherosclerotic events in pa tients with a his tory of ischemic stroke, throm - 

bo sis, myo car dial in farc tion (MI) or es tab lished pe riph eral ar te rial dis ease (PAD) and the treat ment of 

acute cor o nary syn drome (ACS) in com bi na tion with as pi rin. Ma jor com pet i tors in de vel op ment are 

Schering-Plough’s SCH 530348, an orally-ac tive, once-daily thrombin re cep tor an tag o nist, and Lilly’s 

Effient (prasugrel), an oral platelet ag gre ga tion in hib i tor. SCH 530348 was in a large global phase III tri - 

als pro gram in 2008 for the pre ven tion of ischemic com pli ca tions in pa tients with acute cor o nary syn - 

dromes (i.e., un sta ble an gina, acute myo car dial in farc tion), as well as in pa tients with ex ist ing pe riph eral 

ar te rial dis ease. SP ex pect a launch in 2010. Effient was filed for ap proval in the USA in De cem ber 2007 

and in the EU in Feb ru ary 2008 for the treat ment of acute cor o nary syn drome (ACS) in pa tients who are 

man aged with percutaneous cor o nary in ter ven tion (PCI). Effient was rec om mended for ap proval in the 

EU in De cem ber 2008. The filings were despite mixed results and safety problems reported for prasugrel 

in late 2007. 

AstraZeneca was con duct ing phase III tri als with ticagrelor, an oral platelet purinoceptor 2T (P2T) an - 

tag o nist, for the treat ment of ar te rial throm bo sis in acute cor o nary syn drome (ACS) in 2008. AZ an tic i - 

pates fil ing in the USA and Eu rope in H2 2009. 

In Jan u ary 2008 Cogentus be gan phase III tri als with its unique once-daily pill, CGT 2168, that com bines 

clopidogrel with a gastroprotectant, omeprazole. The prod uct is de signed to sig nif i cantly re duce the GI 

side ef fects com monly as so ci ated with antiplatelet ther apy. There are sev eral pro jects in phase II tri als 

Eisai’s (Ja pan) E 5555, an oral thrombin re cep tor an tag o nist. The lat ter be gan a phase II trial in Oc to ber 

2007 eval u at ing the agent in 240 pa tients with coronary artery disease. 

Cardiovascular System Agents 

aliskiren + valsartan — C9X, C9D9 Filed 

valsartan + amlodipine + HCTZ — C9D3 Filed 

aliskiren + amlodipine — C9X, C8A III 

aliskiren + amlodipine + HCTZ — C9X, C8A, C3A III 

ARB/NEP blocker LCZ 696 C2A, C9C II 

pegmusirudin SPP 200 C6A, B1E II 

renin inhibitor SPP 635 C9X II 

atherosclerosis therapy APP 018, APL 180 C6A I 

hypertension therapy LCI 699 C2A I 

hypertension therapy VNP 489 C2A I 



renin inhibitor SPP 800 C9X Preclinical 

ALISKIREN + VALSARTAN: Novartis is de vel op ing a fixed dose com bi na tion of valsartan (Diovan) 

and aliskiren (Tekturna/Rasilez) for the treat ment of hy per ten sion and car dio vas cu lar dis eases. Phase 



III tri als have been con ducted in the USA, Can ada and Eu rope for the treat ment of hy per ten sion. Novartis 

re ported in Jan u ary 2009 that an NDA was filed in the USA in late 2008. 

In April 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, par al lel-group, pla cebo-con trolled, mul ti na - 

tional phase III trial in the USA, Bel gium, Can ada, the Czech Re pub lic, Ger many, Hun gary, the Neth er - 

lands, Po land, Rus sia, Spain and Swe den eval u at ing the ef fi cacy of aliskiren and valsartan ver sus pla cebo 

in low er ing lev els on NT-proBNP in 1100 sta bi lized pa tients with post-acute cor o nary syn dromes. Pri mary 

out come mea sures will de ter mine if aliskiren or valsartan alone and as a com bi na tion re duce the lev els of 

NT-proBNP com pared with pla cebo. Sec ond ary out come mea sures will in ves ti gate if aliskiren or valsartan 

alone and as a combination reduce the rate of adverse cardiac events. 

VALSARTAN + AMLODIPINE + HY DRO CHLO RO THI A ZIDE: In Jan u ary 2009, Novartis re ported 

that it was de vel op ing new car dio vas cu lar tri ple ther apy, a sin gle pill com bi na tion of its mar keted prod uct 

valsartan plus amlodipine (Exforge), and the di uretic, HCTZ. It has been filed for ap proval in the USA. 

Novartis noted that it ex pects an approval in 2009. 

ALISKIREN + AMLODIPINE: In No vem ber 2008, Novartis re ported that it was de vel op ing a sin gle pill 

com bi na tion of its mar keted prod uct aliskiren (Tekturna/Rasilez) and the cal cium an tag o nist 

amlodipine. Novartis states that it ex pects this ther apy to be ap proved be fore the loss of mar ket ex clu siv - 

ity for its flag ship car dio vas cu lar prod uct Diovan (valsartan) in the USA in Sep tem ber 2012. It was in 

phase III trials in February 2009. 

ALISKIREN + AMLODIPINE + HY DRO CHLO RO THI A ZIDE: In No vem ber 2008, Novartis re ported 

that it was de vel op ing new car dio vas cu lar tri ple ther apy, a sin gle pill com bi na tion of its mar keted prod uct 

aliskiren (Tekturna/Rasilez), the cal cium an tag o nist amlodipine, and the di uretic, HCTZ. Novartis 

states that it ex pects this ther apy to be ap proved be fore the loss of mar ket ex clu siv ity for its flag ship car - 

dio vas cu lar prod uct Diovan (valsartan) in the USA in Sep tem ber 2012. In its 2008 an nual re port, 

Novartis noted that it expects a filing in 2010. 

LCZ 696, an oral an gio ten sin II re cep tor blocker (ARB) and neu tral endopeptidase (NEP) in hib i tor, is in 

phase II tri als with Novartis. In No vem ber 2008, Novartis stated, “LCZ 696 is set to en ter phase III tri als 

in 2009 as a po ten tial op tion to re place ACE in hib i tors as the stan dard of care for heart fail ure. Phase II 

stud ies in volv ing 1,300 pa tients showed LCZ 696 pro vided su pe rior blood pres sure re duc tions com pared 

with valsartan alone, and was well-tol er ated with no reported cases of angioedema.” 

Clin i cal Data: In Oc to ber 2007, Novartis ini ti ated a multicenter, ran dom ized, dou ble-blind, pla - 

cebo-con trolled, dose-rang ing phase II trial in the USA and Ger many eval u at ing the ef fi cacy and safety of 

LCZ 696 com par a tively with valsartan af ter an 8-week treat ment in 1,320 pa tients with es sen tial hy per - 

ten sion. Pri mary out come mea sures will in clude mean sit ting di a stolic blood pres sure (MSDBP) low er ing 

from base line to week eight com pared with valsartan and sec ond ary out come mea sures will in clude 

mean sit ting sys tolic blood pres sure (MSSBP)/MSDBP low er ing from base line to week eight com pared 

with pla cebo. Re sults were re ported in De cem ber 2008. The study achieved its pri mary ob jec tive: LCZ 

696 re duced blood pres sure to a greater ex tent than valsartan alone. LCZ 696 was well tolerated and no 

cases of angioedema were observed. 


2011 ($75 mil lion by 2013). 

PEGMUSIRUDIN (SPP 200) is a long-act ing di rect thrombin in hib i tor, in phase II tri als with Speedel 

(Swit zer land), which was ma jor ity ac quired by Novartis in July 2008. 

Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008) fore cast sales of $50 mil lion in 2012 

and $100 mil lion in 2013. 



SPP 635 is a renin in hib i tor, in phase II tri als with Speedel (Swit zer land), which was ma jor ity ac quired by 

Novartis in July 2008. Speedel is de vel op ing SPP 635 for the po ten tial treat ment of hy per ten sion. SPP 635 

was gen er ated from the com pany’s SPP 600 pro gram to de velop a se ries of renin in hib i tors. Speedel has 

car ried out a Eu ro pean phase IIa trial of SPP 635 in the treat ment of hy per ten sion. Re sults have been re - 

ported for this trial. In 2007, Speedel was re ported to be plan ning a fur ther phase II trial in a spe cial pop u - 

la tion of di a betic pa tients with mild-to-moderate hypertension. 

Clin i cal Data: Re sults have been re ported for a dou ble-blind, pla cebo-con trolled, ran dom ized, phase IIa 

trial to eval u ate the safety and ef fi cacy of SPP 635. Thirty five male and fe male pa tients with 

mild-to-mod er ate hy per ten sion re ceived ei ther a sin gle dos age level of SPP 635 once-daily, or pla cebo, 

for four weeks. At the end of the treat ment pe riod, it was found that sit ting sys tolic blood pres sure was 

sig nif i cantly re duced in the SPP 635 treat ment group by 17.9 mmHg, from a mean of 156.6 mmHg at 

base line to 138.7 mmHg (p less than 0.001). The pla cebo group re mained un changed (mean of 156.1 

mmHg at base line to 153.3 mmHg af ter four weeks). Di a stolic blood pres sure was also sig nif i cantly re - 

duced by 9.8 mmHg in the SPP 635 treat ment group, from a mean of 91.3 mmHg to 81.5 mmHg (p less 

than 0.001) com pared with pla cebo (95.3 to 93.3 mmHg). These mea sure ments were taken at trough, 

24 h af ter the pre vi ous med i ca tion. Sim i lar re sults were ob served for am bu la tory blood pres sures which 

were re duced both dur ing the day as well as in the night and these data con firmed the use of SPP 635 as a 

once-a-day drug. SPP 635 was found to be safe and well-tol er ated over the four week treat ment pe riod. 

No se ri ous ad verse events were re ported, nor were there any clinically significant changes in laboratory 

safety parameters. 



APP 018/APL 180 was in phase I tri als in the USA in 2008 for the treat ment of ath ero scle ro sis. In an 

apoE null mouse plasma model APP 018 re mod eled HDL into pre-beta HDL. The pre-beta HDL 

peroxidized lipids from LDL and in ac ti vated them. This re duced per ox ides, in flam ma tory cell ac ti va tion 

and led to less cho les terol ac cu mu la tion in ves sel walls. This al lowed ves sel wall le sions to re gress. 

Novartis is also con duct ing ad di tional pre clin i cal studies with the L-enantiomer only. 

LCI 699, an aldosterone synthase in hib i tor, was in phase I tri als in 2008 as a po ten tial treat ment for hy - 

per ten sion. 

VNP 489 is an in hib i tor of an gio ten sin II re cep tor blocker (ARB) and neu tral endopeptidase (NEP), in de - 

vel op ment as a po ten tial ther apy for the treat ment of hy per ten sion. It was in phase I tri als in 2008. A reg - 

u la tory fil ing is an tic i pated after 2010. 


2012 and $100 mil lion in 2013. 

SPP 1148: Speedel is de vel op ing SPP 1148, a renin in hib i tor from its SPP 1100 se ries, for the treat ment 

of hy per ten sion and re lated end-or gan dis ease. A phase I trial to study the safety and tolerability of sin gle 

and mul ti ple oral doses of SPP 1148 in healthy vol un teers has been ini ti ated. This ran dom ized, pla - 

cebo-con trolled trial will as sess the pharmacokinetics of SPP 1148 and its ca pac ity to in hibit the 

renin-angiotensin system. 

SPP 676: Speedel is de vel op ing SPP 676, a renin in hib i tor, for the treat ment of hy per ten sion and re lated 

dis eases. It orig i nated from Speedel’s SPP 600 se ries of renin in hib i tors. A phase I trial of SPP 676 ini ti - 

ated in October 2007. 

SPP 800: In 2006, Speedel was re ported to be de vel op ing a se ries of small mol e cule renin in hib i tors, 

des ig nated SPP 800, as po ten tial ther a peu tics in car dio vas cu lar and met a bolic dis eases. 



Central Nervous System Agents 

agomelatine AGO 178 N6A, N5B III 

antipsychotic AQW 051 N5A9, N7D9 II 

cannabinoid receptor agonist SAB 378 N7X II 

mGlu5 receptor antagonist AFQ 056 N4A, N7X, A3F II 

vaccine, nicotine withdrawal NIC 002, CYT002-NicQb N7B, J7A9 II 

Alzheimer’s disease therapy CAD 106 N7X, N7D9, J7C I 

antiepileptic BGG 492 N3A I 

multiple sclerosis therapy BAF 312 N7X I 

spinal cord injury therapy ATI 355 N7X I 

VALDOXAN (agomelatine) is a melatonin M1 and M2 ag o nist, with po ten tial as a ther apy for de pres sion 

and other pa thol o gies as so ci ated with dis tur bances in cir ca dian rhythms, such as jet lag and shift work. 

In 2005, li cen sor Servier (France) sub mit ted a fil ing to the EMEA seek ing ap proval of agomelatine in the 

treat ment of ma jor de pres sive dis or der. In July 2006, the EMEA’s Com mit tee for Me dic i nal Prod ucts for 

Hu man Use (CHMP) adopted a neg a tive opin ion re gard ing the ap proval of agomelatine in ma jor de pres - 

sive dis or der. Novartis said this was due to in suf fi cient data and the de ci sion is not ex pected to have any 

ef fect on the de vel op ment strat egy and reg u la tory pro cess in the US, with sub mis sion planned for 2009. 

Servier has sub se quently re-filed the European application with further clinical data. 

Novartis is de vel op ing agomelatine to be come a new once-daily treat ment for pa tients with ma jor de - 

pres sion. It be gan phase III tri als in the US at the end of 2006. Agomelatine has shown ef fi cacy com pa ra - 

ble to cur rent stan dard ther a pies such as SSRIs (se lec tive se ro to nin reuptake in hib i tors) and SNRIs 

(se ro to nin and norepinephrine reuptake in hib i tors) while of fer ing im proved tolerability, in clud ing a low 

pro pen sity to cause sex ual dys func tion and weight gain as well as an improvement in the quality of sleep. 

In March 2007 Novartis ini ti ated a US eight-week, multicenter, ran dom ized, dou ble-blind, ac tive-and 

pla cebo-con trolled phase III trial of agomelatine for the treat ment of ma jor de pres sive dis or der (MDD). 

The study aims to en roll 490 pa tients to eval u ate the ef fi cacy, safety and tolerability of daily 25mg or 

50mg agomelatine and will com pare agomelatine and paroxetine tolerability. One week af ter com ple tion 

of treat ment a sin gle fol low-up visit will be conducted. 

Li cens ing: In 2006, Servier granted Novartis ex clu sive rights to de velop and mar ket agomelatine in the 

USA and sev eral other coun tries. Servier re tains rights in the rest of the world. 

Pat ents: In 1990, a pri or ity prod uct pat ent ap pli ca tion was filed in France by Adir (part of Servier). Ac - 

cord ing to IMS Pat ent Fo cus, pat ents cov er ing the agomelatine prod uct fam ily run to 2011 in Eu rope, Ja - 

pan and the USA. How ever, pro vided that agomelatine is ap proved, the com pa nies can ap ply for up to 

five years ex tra pat ent pro tec tion in Europe, the USA and Japan. 

AQW 051 is a com pound with po ten tial for the treat ment of schizo phre nia, Alz hei mer’s dis ease and cog - 

ni tive de fects. In 2007, Novartis ini ti ated a phase II trial in 125 pa tients with mild Alz hei mer’s dis ease or 

amnestic mild cog ni tive im pair ment. Pri mary out come mea sures will in clude val i dated com put er ized 

cog ni tive as sess ment scores and sec ond ary out come mea sures will in clude qual ity of life and dis abil ity 

as sess ments. Phase I trials have completed in the UK and Japan. 

SAB 378, a cannabinoid (CB1) re cep tor ag o nist, is in phase II tri als for the treat ment of neu ro log i cal in di - 

ca tions. Proof of ef fi cacy stud ies in osteoarthritis and di a betic neu rop a thy have been completed. 

AFQ 056 is a glu ta mate (mGlu5) re cep tor an tag o nist. Novartis be gan a phase II trial in pa tients with Par - 

kin son’s dis ease in 2007. Novartis has also com pleted a phase I trial in GERD. 



In No vem ber 2008, Novartis stated, “AFQ 056, a metabotropic glu ta mate re cep tor 5 (mGlu5) an tag o nist, 

has the po ten tial to be come the first ap proved treat ment for Par kin son’s dis ease levodopa-in duced 

dyskinesia (PD-LID). No ther apy has been ap proved for this dis ease, which is a com pli ca tion af ter do pa - 

mine-re place ment ther apy in Par kin son’s pa tients and char ac ter ized by a va ri ety of hyperkinetic move - 

ments. AFQ re cently showed pos i tive re sults in a proof-of-con cept trial in PD-LID and is pro ceed ing in 

de vel op ment with planned sub mis sions af ter 2011. AFQ 056 shows po ten tial in other dis eases and a 

proof-of-con cept study is un der way for symp tom atic treatment of adults with Fragile X syndrome.” 

Clin i cal Data: In De cem ber 2008 Novartis re ported re sults from a ran dom ized, dou ble-blind, 

proof-of-con cept trial of AFQ 056 in the treat ment of Par kin son’s dis ease as so ci ated levodopa-in duced 

dyskinesia. AFQ 056 ad min is tra tion re sulted in im prove ments in both the Ab nor mal In vol un tary Move - 

ment Scale and Uni fied Par kin son’s Dis ease Rat ing Scale com pared with pla cebo. Novartis plans to sub - 

mit reg u la tory filings for AFQ 056 after 2011. 



NIC O TINE-QBETA (NIC 002), a vac cine that uti lizes Cytos’ (Swit zer land) Immunodrug tech nol ogy, is 

be ing de vel oped by Cytos and Novartis as a treat ment of nic o tine with drawal. Nic o tine-Qbeta con sists of 

nic o tine mol e cules com bined with a highly re pet i tive car rier par ti cle, Qbeta, which mim ics the re pet i tive 

ac tion of a vi rus, in duc ing a strong im mune re sponse. Cytos an tic i pates that the vac cine will block en try 

of nic o tine into the brain. The vac cine is in phase II tri als and Novartis ex pects it to be filed for approval in 

2012 or beyond. 

Li cens ing: Cytos en tered into an ex clu sive global com mer cial li cense agree ment with Novartis to de - 

velop, man u fac ture and com mer cial ize NIC 002 in April 2007. Un der the terms of the agree ment, 

Novartis will re ceive world wide ex clu sive rights for NIC 002 and will be re spon si ble for late-stage clin i cal 

de vel op ment, man u fac tur ing and com mer cial iza tion of the vac cine. In re turn, Cytos is el i gi ble to re ceive 

up to SFr600 mil lion in upfront and de vel op ment, reg u la tory and sales mile stone pay ments, as well as 

sales-re lated roy al ties. The upfront payment by Novartis will be SFr35 million. 


2012 ($200 mil lion by 2013). 

CAD 106, for the treat ment of Alz hei mer’s dis ease, is an immunotherapeutic that can block the for ma - 

tion of beta-am y loid plaques in the brain. In 2008, Novartis was con duct ing a dou ble-blind pla cebo-con - 

trolled phase I trial in 60 pa tients with mild-to-mod er ate Alz hei mer’s dis ease to study the safety, 

tolerability and beta-am y loid spe cific an ti body re sponse af ter CAD 106 treatment. 

Li cens ing: CAD 106 was in-li censed from Cytos (Swit zer land) in 2001. 

BGG 492 was in phase I tri als for the treat ment of ep i lepsy in Swit zer land in 2008. 

BAF 312 is a se lec tive sphingosine 1-phos phate re cep tor ag o nist, in de vel op ment for the treat ment of 

mul ti ple scle ro sis. A phase I trial has been com pleted and Novartis plans to be gin phase II trials in 2009. 

ATI 355 is in de vel op ment with Novartis for use in the treat ment of spi nal cord in jury. A multicenter, 

open-la bel, non-ran dom ized phase I trial to eval u ate the safety, tolerability and pharmacokinetics of four 

dose reg i mens of intrathecal ATI 355 in pa tients with acute spi nal cord in jury is un der way in Ger many. 

Novartis ex pects to file for ap proval of ATI 355 in this in di ca tion in 2010 or later. The US FDA has awarded 

Or phan Drug des ig na tion to ATI 355 for the treat ment of spi nal cord in jury; Or phan Drug des ig na tion is 

pending in the EU. 





Dermatological Agents 

drug delivery system, NexACT, 

terbinafine, Novartis NM 100060 D1A, V7A III 

psoriasis therapy AHT 956 D5B 

Ipsoriasis therapy BCT 194 D5A I 

NM 100060 (drug de liv ery sys tem, NexACT, terbinafine, Novartis) is a top i cal lac quer for mu la tion of 

terbinafine, an antifungal, for the po ten tial treat ment of onychomycosis. The prod uct, which uti lizes 

NexMed’s (USA) pro pri etary NexACT skin ab sorp tion enhancers, con tains less than 1% of the dose of li - 

censed oral terbinafine. Terbinafine is sold by Novartis un der the trade name Lamisil. 

In Jan u ary 2007, Novartis com menced phase III tri als for NM 100060. The pro gram con sists of two piv - 

otal, ran dom ized, dou ble-blind, pla cebo-con trolled stud ies. The par al lel group stud ies are de signed to as - 

sess the ef fi cacy, safety and tolerability of NM 100060 in pa tients with mild to mod er ate toe nail 

onychomycosis. Ap prox i mately 1,000 pa tients will par tic i pate in the two stud ies, which will take place in 

the US, Europe, Canada and Iceland. 

In Au gust 2008, NexMed re ported that an NDA will not be filed with the US FDA at pres ent, based upon 

first in ter pret able re sults from two phase III tri als. Re sults from a Eu ro pean com para tor study are ex - 

pected mid-2009. 

Li cens ing: Novartis ac quired ex clu sive world wide rights to de velop and com mer cial ize NM 100060 from 

NexMed in 2005. 

AHT 956 com pleted phase I tri als with Novartis for use in pso ri a sis in 2008. 

BCT 194 was in phase I tri als with Novartis in 2007 for the treat ment of pso ri a sis. It is re ported to be a 

top i cal antipsoriasis prod uct. 


2012 ($75 mil lion in 2013). 

Hormonal Agents 

drug delivery system, oral 

salmon calcitonin, Emisphere/Novartis SMC 021 H4A, V7A III 

DRUG DE LIV ERY SYS TEM, ORAL SALMON CALCITONIN, EMISPHERE/NOVARTIS: Novartis, in 

part ner ship with Nordic Bio sci ence (Den mark) is de vel op ing SMC 021, an oral ver sion of salmon 

calcitonin, in phase III tri als. Novartis has stated that it an tic i pates fil ing for ap proval of SMC 021 for the 

lead in di ca tion of osteoarthritis in 2011. In Oc to ber 2008, Emisphere re ported that Novartis and Nordic 

Bio sci ence have ini ti ated a sec ond phase III trial of SMC 021 in osteoarthritis pa tients. The trial will eval u - 

ate the safety and ef fi cacy of the agent in pa tients (aged 51-80 years) with pain ful symp toms of knee 

osteoarthritis, and will be con ducted at mul ti ple sites, in clud ing in the USA. The study is de signed to meet 

US FDA reg is tra tion re quire ments, and is expected to complete in H2 2011. 

Li cens ing: SMC 021 uses Emisphere’s (USA) pro pri etary Eligen drug de liv ery tech nol ogy. In 2000, 

Novartis ac quired ex clu sive world wide rights from Emisphere to de velop and com mer cial ize oral 



calcitonin, us ing the Eligen drug de liv ery tech nol ogy. Novartis made a $10 mil lion in vest ment in 

Emisphere. Emisphere is el i gi ble for mile stone pay ments up to $30 mil lion and royalties on any sales. 

Clin i cal Data: In Oc to ber 2008, Emisphere re ported that a phase I study by Novartis and Nordic Bio sci - 

ence dem on strated that oral salmon calcitonin us ing its Eligen tech nol ogy taken 30-60 min utes be fore 

meals with 50ml of wa ter re sults in im proved ab sorp tion and im proved ef fi cacy mea sured by the 

biomarker of re duced bone re sorp tion, com pared to the com monly-pre scribed nasal formulation. 

Musculoskeletal System Agents 

canakinumab ACZ 885 M1C, R3X, V3X, S1P Filed 

drug delivery system, human 

parathyroid hormone — M5B9, H4E, V7A I 

osteoporosis therapy ATF 936 M5B9 I 

RA therapy QAL 964 M1C I 

CANAKINUMAB (ACZ 885), a hu man monoclonal an ti body to IL-1 beta, was filed for ap proval in the US 

and EU in De cem ber 2008 for the treat ment of Cryopyrin-As so ci ated Pe ri odic Syn dromes (CAPS), which 

in clude Muckle-Wells Syn drome (a rare in her ited in flam ma tory con di tion which is man i fested by rash, 

joint aches, fe vers and mi graine head aches). In a trial in pa tients with Muckle-Wells syn drome, all symp - 

toms were re lieved within days by a sin gle in jec tion of ACZ 885. It has an Or phan Drug des ig na tion in the 

EU, Swit zer land and the US for treat ing CAPS. The com pany noted that the first sub mis sions were pre vi - 

ously planned for 2009 but were moved for ward to De cem ber 2008 af ter data from two clin i cal stud ies 

showed adults and chil dren achieved rapid and long lasting clinical remission of these diseases. 

Canakinumab also has po ten tial in rheu ma toid ar thri tis (RA) with less fre quent dos ing than TNF-al pha 

agents. It was in phase II tri als for RA and sys temic ju ve nile id io pathic ar thri tis (the most se vere form of 

ar thri tis in chil dren) in 2008. It has Or phan Drug sta tus for SJIA in the USA and Eu rope. In No vem ber 

2008, Novartis re ported that phase III tri als in SJIA are set to be gin in 2009. Phase III tri als in adult rheu - 

ma toid ar thri tis are set to begin in 2010. 

In No vem ber 2009, Novartis re ported that canakinumab was also in phase II tri als in gout and that it 

plans to be gin phase II tri als in Type 2 di a be tes in 2009. 

Canakinumab is also in phase I tri als for the treat ment of wet age-re lated macular de gen er a tion (AMD). 

In Jan u ary 2007, Novartis ini ti ated a ran dom ized, dou ble-blind, pla cebo-con trolled, 26-week, phase I/II 

study in the USA eval u at ing the safety and ef fi cacy of mul ti ple doses of canakinumab in 130 chronic ob - 

struc tive pul mo nary dis ease (COPD) pa tients. Pri mary out come mea sures will in clude the im pact on pul - 

mo nary func tion in COPD pa tients vs pla cebo and sec ond ary out come mea sures will in clude the im pact of 

mul ti ple doses over a pe riod of 45 weeks, safety and tolerability. This trial is expected to complete in 

March 2009. 

Clin i cal Data: In April 2008, Novartis an nounced re sults from a phase II study of canakinumab in 20 pa - 

tients (aged be tween six and 50 years) with cryopyrin-as so ci ated pe ri odic syn dromes (CAPS), in clud ing 

Muckle Wells syn drome. Pa tients were treated with in jec tions of canakinumab ev ery two months at doses 

of 150 mg in adults and 2 mg/kg in chil dren. Symp toms im proved within one day and all pa tients 

achieved com plete clin i cal re mis sion within seven days. On av er age, clin i cal re mis sion lasted 115 days. 

Canakinumab was well tol er ated, with only mild skin re ac tions at the in jec tion site. The most com mon ad - 

verse events were upper respiratory tract infections. 

In Sep tem ber 2008, Novartis an nounced re sults from a phase I/II trial of canakinumab in 19 pa tients 

with sys temic ju ve nile id io pathic ar thri tis (SJIA) aged four to 19 years. Pa tients in the trial re ceived a sin - 



gle sc dose of canakinumab at 0.5-9 mg/kg. Eleven of 19 pa tients showed at least 50% im prove ment in 

dis ease ac tiv ity within two weeks. Four pa tients were clas si fied as dis ease free. Canakinumab was well 

tol er ated, with the most com mon ad verse event be ing up per respiratory tract infection. 


2010 ($175 mil lion by 2013). 

DRUG DE LIV ERY SYS TEM, HU MAN PARATHYROID HOR MONE: In 2006, Novartis elected to ex er - 

cise an op tion agree ment to de velop and com mer cial ize oral parathyroid hor mone us ing Emisphere’s 

(USA) Eligen tech nol ogy. In 2008, Novartis ini ti ated a phase I trial in Switzerland. 

Clin i cal Data: In No vem ber 2008 Emisphere an nounced re sults from a study of its oral for mu la tion of 

parathyroid hor mone, which uti lizes Emisphere’s eligen tech nol ogy. The study, which in volved 20 

healthy postmenopausal women (40 to 70 years old), dem on strated that the max i mum plasma con cen - 

tra tions of parathyroid hor mone fol low ing ad min is tra tion of Emisphere’s eligen for mu la tion were in the 

same range as those ob tained with teriparatide (Lilly’s Forteo). There were no dis con tinu a tions re lated to 

drug ex po sure, and no sig nif i cant ad verse events or hypocalcaemia were observed. 

ATF 936, an orally-ad min is tered com pound, is be ing de vel oped by Novartis for the treat ment of os teo - 

po ro sis. A phase I trial is on go ing in the USA in ap prox i mately 65 healthy male and fe male sub jects. Pri - 

mary out come mea sures will in clude safety, tolerability, pharmacokinetics and pharmacodynamics of 

sin gle doses of each drug in healthy male and fe male sub jects, head-to-head com par i sons of each drug 

at the ef fec tive dose, and sim i lar ity of pharmacokinetic and pharmacodynamic pro files in healthy 

postmenopausal women. 

QAL 964 is a new treat ment for rheu ma toid ar thri tis, in phase I tri als with Novartis in 2008. 

Respiratory System Agents 

indacaterol QAB 149 R3A Filed 

formoterol + mometasone MFF 258 R3F III 

asthma and COPD therapy QAE 397 R3X II 

asthma/COPD therapy QAT 370 R3G II 

cystic fibrosis therapy QAU 145 R7X II 

drug delivery system, indacaterol + 

glycopyrronium bromide QVA 149 R3G, V7A II 

drug delivery system, inhaled 

glycopyrronium bromide NVA 237, AD 237 R7X II 

indacaterol + mometasone QMF 149 R3F II 

MAb, interleukin-13, Novartis QAX 576 R3X, R7X, R1B II 

COPD therapy QAX 028 R3X I 

asthma therapy VAK 694 R3X Preclinical 

TLR9 immunomodulatory 

oligonucleotides, Idera/Novartis QAX 935 R3X Discovery 

INDACATEROL (QAB 149), a once-daily long-act ing beta 2 adrenoceptor ag o nist for the treat ment of 

chronic ob struc tive pul mo nary dis ease (COPD) and asthma, was filed for ap proval in the USA and EU in 

De cem ber 2008 for COPD. QAB 149 is be ing de vel oped as a monotherapy ini tially, how ever, sev eral 

com bi na tion prod ucts are be ing eval u ated in par al lel. The com pany stated, “This com pound is ex pected 

to form the foun da tion of the Novartis re spi ra tory fran chise, led by the po ten tial com bi na tions, QMF 149 

(in com bi na tion with the corticosteroid mometasone) and QVA 149 (in com bi na tion with the 

anti-muscarinic NVA 237 or glycopyrronium bromide) in COPD and asthma.” 



The QMF 149 pro gram, which com bines QAB 149 with the once-daily in haled corticosteroid 

mometasone (Asmanex), be gan tri als in 2007 with plans for the first reg u la tory sub mis sion in 2010. The 

com bi na tion is be ing de vel oped in col lab o ra tion with Schering-Plough (USA). 

The QVA 149 pro gram is as sess ing in COPD pa tients the po ten tial of a once-daily fixed-dose com bi na - 

tion of QAB 149 and Novartis’ once-daily in haled long-act ing muscarinic an tag o nist NVA 237 

(glycopyrronium bro mide). This novel com bi na tion is ex pected to show su pe rior bronchodilation 

com pared to the in di vid ual com pounds alone due to their com ple men tary mechanisms of action. 

An agree ment was signed in 2003 to com bine QAB 149 with SkyePharma’s multi-dose dry pow der in haler 

de vice to be mar keted by Novartis as Certihaler. 

Li cens ing: In 2006, Schering-Plough en tered into a col lab o ra tion with Novartis to de velop a fixed com bi - 

na tion of the corticosteroid Asmanex (mometasone) and indacaterol, as a once-daily in haled treat ment 

for asthma and COPD. The com bined prod uct, with once-daily dos ing, has the po ten tial to of fer pa tient 

ben e fits in clud ing en hanced dis ease con trol and con ve nience. This pro gram is known as QMF 149. 

Clin i cal Data: In No vem ber 2008 Novartis re ported re sults from an in ter na tional phase III trial of 

indacaterol (QAB 149), in pa tients with COPD. The study, in volv ing over 6,000 pa tients, achieved its pri - 

mary ob jec tive: indacaterol, ad min is tered once daily at 150 mcg or 300 mcg for 52 weeks, re sulted in a 

sta tis ti cally sig nif i cant im prove ment in FEV1 lev els 24 h post-dos ing com pared with pla cebo. Indacaterol 

had a fast on set of ac tion, sim i lar to sal buta mol, and the agent was safe when stud ied at 600 mcg dose for 

one year. 


2009 ($300 mil lion by 2013). 

FORMOTEROL + MOMETASONE (MFF 258): Un der the terms of a 2003 deal, Schering Plough and 

Novartis are co-de vel op ing MFF 258, a com bi na tion prod uct com pris ing Schering-Plough’s corticosteroid 

mometasone (Asmanex) and the Novartis beta2 ag o nist formoterol, as a treat ment for asthma and 

chronic ob struc tive pul mo nary dis ease (COPD). Phase III tri als were un der way in 2008. Novartis plans to 

file for ap proval in COPD and asthma in 2009. 

Sales/An a lyst Com ment: Cowen & Co an a lysts (Au gust 2008), fore cast ini tial sales of $50 mil lion in 

2010 ($125 mil lion by 2013). 

QAE 397 is be ing de vel oped for the po ten tial treat ment of asthma and chronic ob struc tive pul mo nary 

dis ease (COPD). QAE 397 was in phase II tri als in Eu rope in 2008. 


2013. 

QAT 370 is a po ten tial treat ment for asthma and chronic ob struc tive pul mo nary dis ease (COPD) in 

phase II tri als with Novartis in Eu rope in 2008. 


2012 ($100 mil lion by 2013). 

QAU 145 is be ing de vel oped by Novartis for the treat ment of cys tic fi bro sis. In 2007, a phase II trial was 

ini ti ated in the USA to eval u ate safety, tolerability, pharmacokinetics and pharmacodynamics of QAU 145 

ad min is tered via a na sal pump to 14 pa tients with cys tic fi bro sis. Pri mary out come mea sures in clude 

pharmacodynamic re sponses and sec ond ary out come mea sures in clude safety and tolerability. 



DRUG DE LIV ERY SYS TEM, INDACATEROL + GLYCOPYRRONIUM BRO MIDE (QVA 149) is a 

once-daily fixed dose com bi na tion of the once-daily, long-act ing beta-2 ag o nist indacaterol and the 

long-act ing muscarinic an tag o nist, glycopyrronium bro mide (NVA 237), for the treat ment of chronic 

ob struc tive pul mo nary dis or der (COPD). Phase II tri als are on go ing in Eu rope, Can ada and Aus tra lia. Ini - 

tial for mu la tion of the prod uct has been com pleted, us ing Concept1 aerolizer de vice. Novartis be lieves 

this prod uct has po ten tial to be the first once daily fixed-dose combination of two bronchodilators. 

In No vem ber 2007, Sosei and Vectura an nounced the ini ti a tion, by Novartis, of a ran dom ized, dou - 

ble-blind, pla cebo-con trolled, multicenter phase II trial of QVA 149 for the treat ment of COPD. The trial, 

which is ex pected to en roll 250 pa tients aged 40 years or older with mod er ate to se vere sta ble COPD in 

cen ters in Aus tra lia, Bel gium, Can ada, France, Ger many, It aly, Spain and Tur key, will in ves ti gate the ef - 

fect of QVA 149 and indacaterol on the heart to en sure the prod uct is safe. In its 2008 an nual re port, 

Novartis noted that it ex pects to file an NDA for QVA 149 in 2011. 


2012 ($100 mil lion by 2013). 

DRUG DE LIV ERY SYS TEM, IN HALED GLYCOPYRRONIUM BRO MIDE: NVA 237 is a once daily in - 

haled long-act ing muscarinic an tag o nist, for the treat ment of chronic ob struc tive pul mo nary dis ease 

(COPD), in phase II tri als in 2008. It was orig i nated by Sosei (Ja pan, for merly Arakis) and is be ing de vel - 

oped us ing Vectura’s (UK) pro pri etary PowderHale in ha la tion tech nol ogy. Novartis hope to file for ap - 

proval in 2010. NVA 237 be longs to the same class as Boehringer Ingelheim’s lead ing COPD treat ment 

Spiriva (tiotropium bromide). 

Li cens ing: Arakis (now Sosei) and Vectura signed a de vel op ment and com mer cial iza tion deal with 

Novartis in 2005, un der which Novartis will be re spon si ble for de vel op ing NVA 237, both as a 

monotherapy and in com bi na tion with Novartis’ QAB 149 (a long-act ing beta2 re cep tor ag o nist). The deal 

stip u lates that Sosei and Vectura will each re ceive an ini tial pay ment of $15 mil lion. Fur ther pay ments on 

achieve ment of pre-agreed tar gets could to tal up to $172.5 mil lion each for both the monotherapy and 

com bi na tion prod uct. Roy al ties on prod uct sales will be paid for the monotherapy and com bi na tion prod - 

uct. If Novartis de vel ops a third com bi na tion prod uct us ing AD 237/NVA 237, fur ther mile stones and 

royalties may be payable on that product. 

Clin i cal Data: In Oc to ber 2008, Sosei and Novartis pre sented new phase II data at the Eu ro pean Re spi - 

ra tory So ci ety con gress in Ger many show ing that NVA 237 showed prom is ing re sults in two phase II tri - 

als eval u at ing its ef fi cacy, safety and tolerability. The new data showed that NVA 237 pro vides sus tained 

24-hour bronchodilation in pa tients with mod er ate-to-se vere COPD. NVA 237 showed sim i lar ef fi cacy 

and du ra tion of ac tion to tiotropium with po ten tially a more rapid on set of ac tion. In ad di tion, stud ies last - 

ing up to 28 days showed that NVA 237 was safe and well-tol er ated with no clinically relevant 

cardiovascular findings. 


2012 ($100 mil lion by 2013). In Oc to ber 2008, Helvea an a lysts fore cast peak sales of $500 mil lion and 

said that there was still po ten tial up side to that fore cast. Also in Oc to ber 2008, Vontobel an a lyst An drew 

Weiss in creased his peak sales es ti mate to $1 bil lion from $700 mil lion, not ing that the lat est data “con - 

firms find ings that it is po ten tially as ef fi ca cious as Spiriva with a more rapid onset of action. 

INDACATEROL + MOMETASONE (QMF 149): Novartis is de vel op ing QMF 149, a fixed com bi na tion of 

the corticosteroid mometasone and the beta2 ag o nist indacaterol, as a once-daily in haled treat ment for 

asthma and chronic ob struc tive pul mo nary dis ease (COPD). Phase II tri als were on go ing in 2008. 

Novartis does not ex pect to file an NDA in the EU and USA un til af ter 2012. Mometasone is a 

Schering-Plough prod uct, sold by Schering-Plough as Asmanex. This com bi na tion is be ing de vel oped in 

part ner ship with Schering-Plough un der the terms of a 2006 deal. 




2011 ($300 mil lion by 2013). 

QAX 576 is an anti-interleukin-13 monoclonal an ti body in de vel op ment with Novartis for the treat ment 

of asthma, al ler gic rhi ni tis and id io pathic pul mo nary fibrosis. 

In De cem ber 2007, a phase II study was ini ti ated in Ger many and the UK to eval u ate the ef fects of QAX 

576 on al ler gic in flam ma tion fol low ing out of al lergy sea son re peated na sal al ler gen chal lenge in 42 pa - 

tients with sea sonal al ler gic rhi ni tis sen si tive to Tim o thy grass pol len. Pri mary out come mea sures will in - 

clude mark ers of al ler gic in flam ma tion in the nose over 5-8 d post-dose and sec ond ary out come 

mea sures will in clude na sal symp tom scores, blood lev els of the agent and a marker of allergic 

inflammation three months post-dose. 

In Oc to ber 2007, a phase II study of QAX 576 was ini ti ated in the USA to eval u ate a sin gle in tra ve nous 

dose to de ter mine IL-13 pro duc tion in 50 pa tients with id io pathic pul mo nary fi bro sis. Pri mary out come 

mea sures will in clude blood sam ples pre-dose and weekly af ter dos ing to in ves ti gate if some pa tients ex - 

pe ri ence in creased IL-13 pro duc tion. Sec ond ary out come mea sures will in clude changes in biomarkers in 

blood over time. 

QAX 028 was in phase I tri als with Novartis for the treat ment of COPD in 2008. A phase I trial is un der 

way in Den mark to as sess the safety, tolerability, pharmacokinetics and pharmacodynamics of QAX 028 

com pared with open-la bel tiotropium bro mide and pla cebo in 36 mild-to-mod er ate COPD pa tients. Pri - 

mary out come mea sures will in clude safety, tolerability and pharmacodynamics and sec ond ary out come 

mea sures will in clude forced ex pi ra tory vol ume in one sec ond and time pro file us ing a ki netic 

pharmacodynamic model. 


2013. 

VAK 694 was in pre clin i cal stud ies in Swit zer land in 2007 with Novartis for the treat ment of asthma. 

QAX 935 (TLR9 immunomodulatory oligonucleotides, Idera/Novartis): In Sep tem ber 2008 Idera an - 

nounced the ini ti a tion of a phase I trial of QAX 935, a Toll-like re cep tor 9 (TLR9) ag o nist dis cov ered 

through a re search col lab o ra tion be tween Idera and Novartis. In 2005, Hybridon (now Idera) and 

Novartis en tered into re search col lab o ra tion and li cense agree ments for the dis cov ery, op ti mi za tion, de - 

vel op ment and com mer cial iza tion of TLR9 im mune modulatory oligonucleotide can di dates, based on 

Hybridon’s pro pri etary Im mune Modulatory Oligonucleotide (IMO) tech nol ogy plat form, for the treat - 

ment of asthma and al lergy. In March 2007, Idera and Novartis ex tended the term of the re search phase 

of their col lab o ra tion by one year. Novartis has in-li censed the ex clu sive rights to QAX 935 from Idera. 

Ini ti a tion of this phase I trial triggered a milestone payment from Novartis to Idera. 

Sensory Organ Agents/Ophthalmologicals 

glaucoma therapy Y 39983 S1E II 

glaucoma therapy RKI 983 S1E I 

glaucoma therapy SAD 448 S1E I 

Y 39983, a rho kinase in hib i tor for the top i cal treat ment of glau coma, was in phase II tri als in Ja pan in 

2009. It has a new mech a nism of ac tion that reg u lates pres sure in side the eye. 

Li cens ing: Novartis ac quired rights to Y 39983 in 2005 from Senju (Ja pan). Mitsubishi Pharma (now 

Mitsubishi Tanabe, Ja pan) was the orig i na tor, but granted world wide rights to Senju in 2000. 



RKI 983 is a po ten tial treat ment for glau coma, in phase I tri als with Novartis in Eu rope in 2008. 

SAD 448 was in phase I tri als with Novartis for the treat ment of glau coma and oc u lar hy per ten sion in 

2008. 

Clin i cal Data: In April 2007, a ran dom ized, pla cebo-con trolled, dou ble-masked, 4-arm par al lel, phase I 

trial ini ti ated in Aus tra lia as sess ing the tolerability, safety and ef fi cacy of two doses of Novartis’ SAD 448 

in 80 pa tients with oc u lar hy per ten sion. Pri mary out come mea sures will in clude rates of ad verse events 

and se ri ous ad verse events as well as changes in oph thal mic eval u a tions, lab o ra tory val ues, ECGs and vi - 

tal signs from base line up to 24 h post-dos ing. Sec ond ary out come mea sures will in clude changes in oc u - 

lar hy per ten sion and sys temic ex po sure to SAD 448 following administration of the two doses. 

Systemic Anti-Infective Agents 

vaccine, pandemic influenza, Novartis — J7A1 Approved 

efungumab — J2A, L1X3 Filed 

vaccine, Japanese encephalitis virus, 

Intercell IC51 J7A9 Filed 

vaccine, meningococcal ACWY, Novartis MenACWY J7A8 Filed 

albinterferon alfa-2b ABF 656 J5B, L3B1 III 

vaccine, Neisseria meningitidis group B, 

Novartis MenB J7A8 III 

vaccine, pre-pandemic influenza, Novartis — J7A1 III 

carbapenem antibiotic PTZ 601, SMP 601, SM 216601 J1P2 II 

HCV therapy IDX 184 J5B1 II 

reverse transcriptase inhibitor IDX 899 J5C3 II 

RSV therapy RSV 604, A 60444 J5B5 II 

vaccine, HCV epitope-based, Intercell IC41, IC 41, IC 41202 J7A3 II 

vaccine, pseudomonas aeruginosa, 

Intercell — J7A9 II 

hepatitis C therapy NIM 811, SDZ 811 J5B1 I 

vaccine adjuvant IC31 J7C, L3A9 I 

vaccine, cytomegalovirus, Novartis — J7A9 I 

vaccine, Group B Streptococcus, Novartis — J7A9 I 

vaccine, H pylori, Novartis — J7A9 I 

vaccine, HIV infection, Novartis — J7A9, J5C9 I 

HCV NS3/4A protease inhibitors, Idenix — J5B1 Preclinical 

RNA polymerase inhibitor IDX 375 J5B1 Preclinical 

vaccine, Borrelia, Novartis — J7A9 Preclinical 

vaccine, Candida, Novartis — J7A9 Preclinical 

vaccine, Chlamydia, Novartis/Intercell — J7A9 Preclinical 

vaccine, Group A Streptococcus, Novartis — J7A9 Preclinical 

vaccine, Group B Streptococcus, Novartis/ 

Intercell — J7A9 Preclinical 

vaccine, influenza, Dynavax — J7A1 Preclinical 

vaccine, Klebsiella, Novartis/Intercell — J7A9 Preclinical 

vaccine, otitis media, Novartis/Intercell — J7C Preclinical 

vaccine, Streptococcus pneumoniae, 

Novartis/Intercell — J7A7 Preclinical 

FOCETRIA (vac cine, pan demic in flu enza, Novartis) is a vac cine for use in a pan demic in flu enza out - 

break. It will be man u fac tured to con tain the pan demic in flu enza vi rus strain de clared at the time of a 

pan demic, com bined with Novartis’ pro pri etary MF59 adjuvant that al lows smaller amounts of vi ral an ti - 

gens to be used. The vac cine was ap proved in the EU, Nor way and Ice land for vac ci na tion against pan - 

demic in flu enza strains in May 2007. Novartis will sub mit a re vised ap pli ca tion to the EMEA to in cor po rate 

the vi ral strain once the WHO declares a pandemic. 



The reg u la tory fil ing was sub mit ted to the EMEA in early 2006 and was con sid ered ‘mock-up’ be cause it 

laid the ground work for a more rapid ap proval (af ter sub mis sion of a re vised fil ing) and avail abil ity of the 

vac cine upon dec la ra tion of a pan demic by the WHO. The fil ing was based on re sults from tri als in volv ing 

the MF59 adjuvant and po ten tially pan demic in flu enza strains, including H5N1 and H9N2. 

MYCOGRAB (efungumab) is a hu man ge net i cally re com bi nant an ti body that tar gets heat shock pro tein 

90 (HSP90). Novartis is de vel op ing efungumab as a po ten tial treat ment for in va sive candidiasis, can cer 

and cryptococcal men in gi tis. It was orig i nally de vel oped by NeuTec (ac quired by Novartis in 2006). 

NeuTec sub mit ted an ap pli ca tion seek ing Eu ro pean ap proval for the treat ment of in va sive candidiasis in 

2005. It re ceived a num ber of ques tions from the EMEA, which later is sued a neg a tive opin ion for the 

prod uct. Novartis and NeuTec ap pealed, but in March 2007, the EMEA maintained its negative opinion. 

In June 2006, a multicenter, ran dom ized, dou ble-blind, pla cebo-con trolled, phase III trial ini ti ated in 

Swit zer land as sess ing the ef fi cacy and safety of efungumab as ad junc tive ther apy for cryptococcal men - 

in gi tis in 150 pa tients with AIDS. The trial is ex pected to com plete in June 2009. In Jan u ary 2009, 

Novartis noted that a fil ing for ap proval in men in gi tis and a fil ing for use in in va sive candidiasis may take 

place in 2012 or later. 

A phase Ib trial for use in the treat ment of breast can cer has been com pleted. Mycograb has Or phan Drug 

sta tus in the US and the EU for use against in va sive fun gal in fec tions, and has dem on strated su pe ri or ity 

in clin i cal out comes in com bi na tion with amphotericin B over amphotericin B monotherapy, with re duc - 

tion in Candida-re lated mor tal ity and mycological superiority. 


2010 ($100 mil lion by 2013). 

IXIARO (vac cine, Jap a nese en ceph a li tis vi rus, Intercell) is a pro phy lac tic vac cine against Jap a nese en - 

ceph a li tis vi rus in fec tion, orig i nated by Intercell (Aus tria). It was sub mit ted for ap proval in the US and the 

EU in 2007. Global, multicenter phase III tri als as sessed the immunogenicity and safety of the com pound 

in more than 4,900 sub jects. Immunogenicity stud ies in Aus tria, Ger many and the USA were de signed to 

show non-in fe ri or ity in com par i son with the JE-VAX vac cine. Ad di tional phase III tri als are ex pected to 

gather more data from 4,000 sub jects re cruited in Aus tria, Aus tra lia, Bul garia, Ger many, Is rael, the 

Neth er lands, New Zea land, Ro ma nia, the UK and the USA. In Jan u ary 2009, Novartis, which has rights in 

the EU and USA, plus a num ber of other coun tries, stated that it ex pects an EU ap proval in the first half of 

2009 af ter re ceiv ing a pos i tive rec om men da tion from the CHMP in December 2008. It also anticipates US 

approval in H1 2009. 

Li cens ing: In 2005, Intercell signed an agree ment with Bi o log i cal E, un der which the lat ter will de velop, 

man u fac ture and mar ket the vac cine in Asia. In 2006, Intercell granted Novartis rights in the USA, Eu - 

rope and other mar kets in clud ing Asia and Latin Amer ica. In re turn, Novartis will make an eq uity in vest - 

ment in Intercell of up to Euro30 mil lion. This will grant Novartis first ne go ti a tion rights to cer tain Intercell 

tech nol ogy de rived prod uct can di dates. Intercell will also re ceive mile stone pay ments re lated to fi nal 

phase III data, and upon US and EU ap proval of the prod uct. In Jan u ary 2009, Intercell an nounced that 

the Aus tra lian Ther a peu tic Goods Ad min is tra tion (TGA) has granted ap proval for the vac cine, fol low ing a 

pos i tive opin ion rec om mend ing ap proval by the Aus tra lian Drug Eval u a tion Com mit tee (ADEC) in De - 

cem ber 2008. The vac cine will be mar keted as Jespect by CSL, which has ex clu sive mar ket ing and dis tri - 

bu tion rights for the vaccine in Australia, New Zealand, Papua New Guinea and the Pacific Islands. 

Clin i cal Data: In 2006, Intercell re ported ini tial re sults from its phase III safety trial of IC51 in 2683 

healthy vol un teers. Re sults from the multicenter, mul ti na tional, dou ble-blind, pla cebo-con trolled, ran - 

dom ized trial showed that IC51 was sys tem i cally and lo cally well tol er ated with the over all lo cal 

tolerability and gen eral safety pro file com pa ra ble to pla cebo. This on go ing trial is part of a global, 



multicenter phase III pro gram to as sess the immunogenicity and safety of IC51 in more than 4,900 

subjects. 

MENVEO (vac cine, meningococcal ACWY, Novartis) is a con ju gate quad ri va lent ACWY vac cine against 

the A, C, W135 and Y serogroups of Neisseria meningitides, im por tant causes of bac te rial men in gi tis. 

Phase III tri als in volv ing 13,000 peo ple be gan in 2006, tar get ing reg u la tory sub mis sion for use in in fants, 

ad o les cents, and adults. Novartis has filed it for ap proval in the USA (Au gust 2008) and the EU (Oc to ber 

2008): both sub mis sions are for ages 11-55. US approval is anticipated in 2009. 

In April 2007, Novartis ini ti ated a phase III trial of Menveo in Co lom bia and Ar gen tina. This trial will eval u - 

ate the safety and im mune re sponse of the vac cine in adults and ad o les cents in com par i son with a li - 

censed con ju gate meningococcal ACWY vac cine and with a li censed polysaccharide vac cine in 3,000 

sub jects. A safety/ef fi cacy phase III trial was also ini ti ated in the USA in March 2007. This study will eval - 

u ate the safety of the vac cine and im mune re sponse in 3,000 adults and ad o les cents. An other phase III 

trial ini ti ated in March 2007 in 4,500 healthy in fants in Ar gen tina, to eval u ate the safety and 

immunogenicity of Menveo when ad min is tered with rou tine vac ci na tions. Reg u la tory sub mis sions for use 

in chil dren from two years to 10 years were planned for 2009, but fol low ing dis cus sions with the FDA in 

late 2008, the phase III pro gram in chil dren aged two to ten years was ex panded by 1,500 in fants and 

this will mean a sub mis sion in the US for this age group is not expected until 2011. 

Novartis de scribes Menveo as a new vac cine pro tect ing against four com mon types of meningococcal 

men in gi tis known as A, C, W-135 and Y. This bac te rial dis ease is a rare, but po ten tially fa tal, in fec tion that 

causes in fec tion of the mem branes around the brain and spi nal cord. Novartis states that the lat est phase 

III data sug gests that Menveo has the po ten tial to be come the first vac cine to pro tect from in fancy to 

adult hood against these four common serogroups. 

Clin i cal Data: In Jan u ary 2008, Novartis re ported data from a phase II trial of Menveo con ducted in 421 

in fants in the UK and Can ada. In the study, some pa tients re ceived three doses of the vac cine at two, 

three and four months and oth ers at two, four and six months. At month 12, some par tic i pants re ceived 

an ad di tional dose of MenACWY or a plain meningococcal polysaccharide. Re sults showed that Menveo 

was well tol er ated, and one month af ter the last pri mary im mu ni za tion it pro duced high lev els of 

immunogenicity against meningococcal serogroups A, C, W-135 and Y, with 93% of in fants achiev ing 

hSBA titers of greater than or equal to 1:4 in the two, three, four-month group. Ad di tion ally, the dose at 

month 12 gen er ated a strong im mune response in all four serogroups. 

In May 2008, Novartis an nounced first phase III head-to-head data com par ing its multivalent con ju gate 

vac cine against Neisseria meningitidis serogroups A, C, W and Y (Menveo/MenACWY) with the li censed 

vac cine Menactra. In this US trial, more than 2,100 ad o les cents aged 11-18 years re ceived a sin gle vac - 

ci na tion with Menveo or Menactra, and im mune re sponses against meningococcal serogroups A, C, 

W-135 and Y were higher with Menveo. 

Com pe ti tion: In 2000, Wyeth launched Prevnar (vac cine, pneumococcal 7-valent con ju gate), the first 

vac cine aimed at pre vent ing in va sive pneumococcal dis ease in in fants and tod dlers (up to two years old), 

such as otitis me dia (mid dle-ear in fec tions), pneu mo nia, bacteremia, and bac te rial men in gi tis. It is now 

de vel op ing an im proved ver sion, known as Prevnar 13 (vac cine, 13-valent pneumococcal con ju gate). 

In De cem ber 2008, Wyeth re ported that it has sub mit ted an MAA to the EMEA for ap proval to mar ket 

Prevnar 13 for the pre ven tion of pneumococcal dis ease in in fants and young chil dren. The re view of the 

MAA will be co or di nated by the EMEA for all EU coun tries, plus Nor way, Ice land and Liech ten stein. Wyeth 

ex pects to file for pe di at ric ap proval in the USA in Q1 2009. Phase III eval u a tion of the vac cine in adults is 

on go ing, and fil ings for use in adults are an tic i pated in 2010. In the 12-month pe riod to the end of Sep - 

tem ber 2008, Prevnar was the num ber two prod uct in the J7A class (Pure Vaccines), with sales of $1,437 

million, according to IMS. 



ALBUFERON (albinterferon alfa-2b) is a pro tein com pris ing in ter feron alfa-2b fused with al bu min, which 

is pro duced from the fused genes for these in di vid ual pro teins. It was orig i nated by Hu man Ge nome Sci - 

ences (USA) and is be ing de vel oped pri mar ily for the treat ment of chronic hep a ti tis C. It en tered phase III 

tri als with Novartis in 2006. The fu sion pro tein is ex pected to have pro longed ther a peu tic ac tiv ity and an 

im proved side ef fect pro file com pared with re com bi nant hu man in ter feron alfa. Other in di ca tions for 

which this fu sion pro tein has po ten tial in clude hep a ti tis B vi rus in fec tion, hairy cell leu ke mia, ma lig nant 

mel a noma, non-Hodgkin’s lymphoma and chronic myelogenous leukemia. 

In terim re sults from phase II tri als, in which treat ment-na ive pa tients re ceived Albuferon in com bi na tion 

with ribavirin, showed it has the po ten tial for an im proved ef fi cacy and tolerability pro file with the need for 

fewer in jec tions com pared to pegylated in ter feron, the cur rent stan dard of care. A first reg u la tory sub - 

mis sion is planned for 2009. 

In Jan u ary 2009, Novartis ini ti ated a ran dom ized, open-la bel, multicenter, ac tive-con trolled, adap - 

tive-de sign, dose-rang ing phase IIb trial of albinterferon alfa-2b in treat ment-na ive pa tients with ge no - 

types 2 and 3 chronic hep a ti tis C vi rus (HCV) in fec tion. The trial is ex pected to re cruit ap prox i mately 375 

pa tients in four treat ment arms; three arms will re ceive albinterferon alfa-2b at doses of 900, 1200 or 

1500 mcg once ev ery four weeks for 24 weeks, and the ac tive con trol group will re ceive 180 mcg 

peginterferon alfa-2a once weekly for 24 weeks. All pa tients will also re ceive daily oral ribavirin (800 mg). 

Sus tained virologic re sponse at week 48 will be the pri mary efficacy endpoint of the trial. 

Li cens ing: In 2006, li cen sor and pat ent holder Hu man Ge nome Sci ences and Novartis agreed to 

co-mar ket Albuferon in the USA; Novartis will com mer cial ize Albuferon in ter ri to ries out side the USA. 

Clin i cal de vel op ment costs will be shared. HGS will re ceive an upfront pay ment of $45 mil lion, plus clin i cal 

de vel op ment, com mer cial mile stone and other pay ments of up to $507.5 million. 

Clin i cal Data: In De cem ber 2008, re sults of the phase III ACHIEVE 2/3 trial were re ported and Albuferon 

was found to have met its pri mary end point of non-in fe ri or ity to Pegasys. Both drugs were given in com - 

bi na tion with ribavirin in the trial of 933 treat ment-na ive pa tients with ge no type 2 and 3 HCV. In Jan u ary 

2008, HGS low ered the dose of Albuferon in this trial be cause of lung-re lated safety con cerns. Pa tients 

who were re ceiv ing the 1,200mcg dose ev ery two weeks, were changed to re ceive the 900mcg in jec tions 

ev ery two weeks af ter the stud ies’ data mon i tor ing com mit tees ob served higher rates of lung-re lated 

com pli ca tions. There was no safety concerns associated with the lower dose. 

Com pe ti tion: Ver tex Pharmaceuticals’ (USA) ri val new hep a ti tis C drug, telaprevir, is in phase III tri - 

als. It has been li censed-out to J&J and to Mitsubishi Tanabe. 


2010 ($125 mil lion by 2013). 

MENB (vac cine, Neisseria meningitidis group B, Novartis) is a re com bi nant vac cine against in fec tion with 

Neisseria meningitidis group B. Novartis is con duct ing the de vel op ment of this prod uct in col lab o ra tion 

with Ox ford Uni ver sity (UK). This new vac cine is be ing de vel oped to pro tect against a ma jor ity of global 

strains for the men in gi tis B serogroup, for which no vac cine is cur rently avail able. The ge nome of N. 

meningitidis, the or gan ism re spon si ble for the dis ease, was se quenced and cell sur face an ti gens iden ti - 

fied; re verse vaccinology was used to iden tify a set of an ti gens that are con served across known B 

serotypes of N meningitidis, and a vac cine de vel oped from a limited set of the identified antigens. 

In 2006, Novartis ini ti ated a phase II trial of MenB in healthy in fants of two months of age. The open-la - 

bel, con trolled, ran dom ized, multicenter trial will eval u ate the safety, tolerability, and immunogenicity of 

two for mu la tions of the vac cine in 150 sub jects in the UK. Re sults from pre vi ously con ducted phase I tri - 

als of MenB showed broad cov er age against most prev a lent strains of N meningitidis. 



In July 2008, Novartis re ported that a phase III trial in in fants and chil dren is un der way. The first reg u la - 

tory sub mis sions, for use in in fants and chil dren, ac cord ing to Novartis, are planned for 2010. 

AFLUNOV (vac cine, pre-pan demic in flu enza, Novartis) is a pre-pan demic vac cine which con tains the 

MF59 adjuvant, against H5N1 in flu enza. The vac cine was filed for ap proval in the EU in 2006 and is in 

phase II tri als in the USA. How ever, in June 2008 Novartis no ti fied the EMEA of its de ci sion to with draw its 

MAA (sub mit ted in No vem ber 2006), seek ing ap proval of Aflunov for ac tive pre-pan demic im mu ni za tion 

against H5N1 sub type of the in flu enza A vi rus. The de ci sion was based on a re quest by the CHMP for ad di - 

tional clin i cal data be cause the main study had not been con ducted in com pli ance with Good Clin i cal Prac - 

tice (GCP); the re quest could not be met within the timeframe allowed by the centralized procedure. 

Aflunov was the first such vac cine sub mit ted to EU reg u la tory au thor i ties. Aflunov is based on the cur - 

rently cir cu lat ing H5N1 in flu enza strain, and clin i cal data have dem on strated that it is pro tec tive for this 

strain as well as of fer ing a de gree of pro tec tion from other re lated strains. Aflunov also con tains the MF59 

adjuvant, strength en ing the im mune re sponse to the vac cine, and help ing to pro vide a de gree of 

cross-strain pro tec tion. Clin i cal stud ies in more than 4,000 peo ple have dem on strated that Aflunov is as 

safe as Fluad, the adjuvanted seasonal-flu vaccine from Novartis. 

PTZ 601, a carbapenem an ti bi otic, en tered phase II tri als in the USA in 2008 with Protez (USA), which 

was ac quired by Novartis in June 2008, in the treat ment of pa tients with com pli cated skin and skin struc - 

ture in fec tions. PZ 601 is a 1-beta-methylcarbapenem with an ex tended spec trum of ac tiv ity against 

multidrug-re sis tant Gram pos i tive patho gens, in clud ing methicillin-re sis tant Staph y lo coc cus aureus, and 

Gram neg a tive bac te ria. Protez was ac quired by Novartis in June 2008. In June 2008, Novartis stated that 

it plans to start ad di tional clin i cal tri als for PZ 601, with the aim of first regulatory submission in 2012. 

Li cens ing: Protez li censed-in rights to PZ 601 in Eu rope and North Amer ica from orig i na tor Sumitomo 

Pharma (now Dainippon Sumitomo, Ja pan) in 2005. 

IDX 184, an oral, liver-tar geted nu cle o tide prodrug, be gan phase I/II tri als in Jan u ary 2009 in treat - 

ment-na ive pa tients with chronic hep a ti tis C vi rus (HCV) ge no type 1 in fec tion. The dou ble-blind, pla - 

cebo-con trolled, dose-es ca la tion, proof-of-con cept study will eval u ate the safety and an ti vi ral ac tiv ity of 

four oral doses of the agent (25 to 100 mg), given once daily for three days. Each co hort will eval u ate ten 

pa tients, eight re ceiv ing IDX 184 and two re ceiv ing pla cebo. A phase I trial begun in July 2008 has been 

completed. 

In April 2008, Idenix re ported re sults of pre clin i cal stud ies of IDX 184, a nucleoside RNA poly mer ase in - 

hib i tor be ing de vel oped for the oral treat ment of hep a ti tis C vi rus (HCV) in fec tion. IDX 184 was de rived 

from Idenix’s pro pri etary liver-tar get ing tech nol ogy. In chim pan zees with HCV ge no type 1 in fec tion, oral 

ad min is tra tion of 10 mg IDX 184 once-daily for four days re sulted in a mean vi ral load re duc tion of 2.3 

log10. In a seven-day tox i col ogy study in Cynomolgus mon keys, oral doses of 600 mg/kg per day re - 

sulted in no ob served tox ic i ties, in clud ing gas tro in tes ti nal or he ma to log i cal, or ab nor mal blood chem is try. 

In an HCV replicon model IDX 184 showed ad di tive an ti vi ral ac tiv ity in com bi na tion with HCV pro te ase in - 

hib i tors and in ter feron, and syn er gis tic ac tiv ity in com bi na tion with ribavirin. IDX 184 was ac tive against 

HCV with pro te ase and non-nucleoside in hib i tor drug resistance mutations. Idenix is planning to file an 

IND for IDX 184 during 2008. 

Li cens ing: In 2003, Novartis paid $255 mil lion for ap prox i mately 54% of pri vately-owned Idenix’s out - 

stand ing cap i tal stock, gain ing rights to de velop and com mer cial ize Tyzeka (telbivudine) and other drug 

can di dates dis cov ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008. 

IDX 899: IDX 899 is a non-nucleoside re verse tran scrip tase in hib i tor (NNRTI), in phase II tri als with 

Idenix, which is ma jor ity-owned by Novartis. 




stand ing cap i tal stock, gain ing rights to de velop and com mer cial ize telbivudine and other drug can di - 

dates dis cov ered by Idenix. Novartis was re ported to hold a 56% stake in Idenix in 2008. 

In Feb ru ary 2009, GlaxoSmithKline ac quired ex clu sive global rights to Idenix’s IDX 899. All de vel op ment 

of IDX 899 and as so ci ated costs will be as sumed by GSK. In re turn, Idenix will re ceive an upfront pay - 

ment of $34 mil lion and up to $416 mil lion in de vel op ment, reg u la tory and sales mile stones. Upon suc - 

cess ful com mer cial iza tion, Idenix will re ceive dou ble digit, tiered roy al ties on world wide sales. IDX 899 is 

a non-nucleoside re verse tran scrip tion in hib i tor, in phase II tri als as a potential therapy for HIV infection. 

Clin i cal Data: In Sep tem ber 2008, Idenix re ported re sults from a phase I/II study of IDX 899 in treat - 

ment-na ive pa tients with HIV-1 in fec tions. Sub jects were en rolled onto four co horts to re ceive ei ther 

800, 400, 200 or 100 mg IDX 899 or pla cebo once-daily for seven days. Af ter seven days of treat ment 

pa tients re ceiv ing 100, 200, 400 and 800 mg/day IDX 899 achieved mean re duc tions in plasma vi ral load 

of 1.87, 1.84, 1.78 and 1.78 log10, re spec tively. For pla cebo-treated pa tients a mean in crease in vi ral 

load of 0.10 log10 was ob served. No pa tients in any dose co hort ex pe ri enced se ri ous ad verse events and 

no pa tients dis con tin ued the study. The most com monly re ported ad verse events were dys pep sia, head - 

ache and nau sea; these events oc curred at a sim i lar rate in the placebo and IDX 899 treated cohorts. 

In Feb ru ary 2008, Idenix re ported data from a phase I/II trial to eval u ate the safety, tolerability and an ti - 

vi ral ac tiv ity of IDX 899. In the first co hort, eight and two HIV-1-in fected, treat ment-na ive pa tients were 

given a seven-day course of 800 mg IDX 899 and pla cebo, re spec tively. Pa tients given IDX 899 achieved 

a mean and me dian plasma vi ral load de crease of 2.01 log10 and 2.11 log10, re spec tively, af ter the 

seven-day treat ment. Six of eight pa tients achieved a 2 log10 or greater de crease in vi ral load with one 

pa tient achiev ing un de tect able vi rus lev els (less than 50 cop ies/mL). No se ri ous ad verse events were re - 

ported and no pa tients dis con tin ued the study. A co hort of 400 mg IDX 899 once-daily fol lowed by a co - 

hort of 200 mg IDX 899 once-daily will be evaluated. 

RSV 604/A 60444 is an oral small mol e cule, in phase II tri als for the po ten tial treat ment of re spi ra tory 

syncytial vi rus (RSV) in fec tion in 2008, in Aus tra lia, Eu rope and the USA. 

Li cens ing: In 2005, Novartis and orig i na tor Ar row (UK) signed a li cens ing deal, un der which Novartis will 

de velop, com mer cial ize and fund all fu ture work re lated to RSV 604. Ar row will re ceive an upfront pay - 

ment of $10 mil lion, de vel op ment-re lated mile stone pay ments of up to $217 mil lion and roy al ties on 

sales. Rights to back-up com pounds to RSV 604 are in cluded in the deal, plus a right of first ne go ti a tion on 

fol low-up com pounds with dif fer ent chem is try, in de vel op ment with Ar row. Ar row was acquired by 

AstraZeneca in March 2007. 

Clin i cal Data: In 2005, Ar row re ported re sults from a dou ble-blind, pla cebo-con trolled, seven-day, oral 

dose-es ca la tion study of A 60444 in healthy vol un teers. In the trial, 24 sub jects were ran dom ized to the 

fol low ing treat ment groups: 150mg daily for seven days; 300mg once daily for seven days; or a load ing 

dose of 600mg on day 1 fol lowed by 450mg on days two to seven. Re sults showed that A 60444 was well 

tol er ated in all dos ing reg i mens; no se ri ous ad verse event was re ported. A to tal of 17, 13 and six ad verse 

events were re ported in the 150, 300 and 600/450mg reg i mens, re spec tively; all events re solved. A 

60444 plasma con cen tra tions above the in vi tro IC90 value were achieved in all three treatment groups. 

Sales/An a lyst Com ment: In dus try an a lysts have es ti mated that the mar ket for RSV treat ments could 

grow up to $2.5 billion. 

TRANSVAX HCV (vac cine, HCV epitope-based, Intercell) is a vac cine for the treat ment of hep a ti tis C vi - 

rus (HCV) in fec tion de vel oped us ing Intercell’s (Aus tria) pro pri etary Transvax tech nol ogy, and com prises 

five T-cell epitopes of HCV cou pled with an immunostimulatory com pound. Intercell has ini ti ated a phase 



II trial of IC41 in 50 chronic hep a ti tis C pa tients in Ger many, Po land and Ro ma nia who have not received 

previous treatment. 

Li cens ing: In 2007, Novartis and Intercell es tab lished a stra te gic al li ance re lat ing to the de vel op ment of 

vac cines for in fec tious dis eases. The col lab o ra tion will fo cus on the de vel op ment of an ti bac te rial vac cines 

de rived from Intercell’s An ti gen Iden ti fi ca tion Pro gram (AIP) and the use of Intercell’s IC31 adjuvant 

tech nol ogy in se lected new vac cines. Novartis will make an upfront pay ment of Euro120 mil lion to 

Intercell in op tion and li cense fees. Intercell will re ceive a Euro150 mil lion cash con tri bu tion from 

Novartis, through pur chase of 4.8 mil lion Intercell shares, in creas ing Novartis’ eq uity stake in Intercell to 

16.2% from the cur rent 6.1%. Novartis ac quires opt-in rights for the de vel op ment, man u fac tur ing and 

com mer cial iza tion of Intercell’s non-part nered vac cine tar gets in its AIP af ter the com ple tion of phase II 

tri als (or ear lier at Novartis’ elec tion). Intercell re tains the right to choose be tween co-de vel op - 

ment/profit-shar ing or li cens ing with pre de fined mile stone and roy alty pay ments for AIPs that Novartis 

chooses for fur ther de vel op ment. Novartis ac quires ex clu sive rights to Intercell’s IC31 adjuvant for use in 

de vel op ing in flu enza vac cines. Intercell is el i gi ble for up to Euro100 mil lion in mile stones dur ing the de - 

vel op ment pe riod and dou ble-digit roy al ties tied to sales per for mance. Novartis also ac quires a non-ex - 

clu sive li cense to IC31 in other ar eas. Intercell will re ceive Euro30-60 mil lion dur ing the de vel op ment 

pe riod in upfront pay ments and mile stones, and up to high sin gle-digit roy al ties tied to sales per for mance 

for each fu ture li cense for IC31 in se lected ar eas. The agree ment also in cludes co-de vel op ment and 

profit-shar ing in a collaboration to combine the hepatitis C virus (HCV) infection programs of both 

companies; this includes Intercell’s IC41 vaccine. 

VAC CINE, PSEU DO MO NAS AERUGINOSA: In Jan u ary 2009, Novartis re ported that it was con duct ing 

phase II tri als of this vac cine in col lab o ra tion with Intercell (Austria). 

Li cens ing: In 2007, Novartis and Intercell es tab lished a stra te gic al li ance re lat ing to the de vel op ment of 

vac cines for in fec tious dis eases. The col lab o ra tion will fo cus on the de vel op ment of an ti bac te rial vac cines 

de rived from Intercell’s An ti gen Iden ti fi ca tion Pro gram (AIP) and the use of Intercell’s IC31 adjuvant 

tech nol ogy in se lected new vac cines. Novartis will make an upfront pay ment of Euro120 mil lion to 

Intercell in op tion and li cense fees. Intercell will re ceive a Euro150 mil lion cash con tri bu tion from 

Novartis, through pur chase of 4.8 mil lion Intercell shares, in creas ing Novartis’ eq uity stake in Intercell to 

16.2% from the cur rent 6.1%. Novartis ac quires opt-in rights for the de vel op ment, man u fac tur ing and 

com mer cial iza tion of Intercell’s non-part nered vac cine tar gets in its AIP af ter the com ple tion of phase II 

tri als (or ear lier at Novartis’ elec tion). Intercell re tains the right to choose be tween co-de vel op - 

ment/profit-shar ing or li cens ing with pre de fined mile stone and roy alty pay ments for AIPs that Novartis 

chooses for fur ther de vel op ment. Novartis ac quires ex clu sive rights to Intercell’s IC31 adjuvant for use in 

de vel op ing in flu enza vac cines. Intercell is el i gi ble for up to Euro100 mil lion in mile stones dur ing the de - 

vel op ment pe riod and dou ble-digit roy al ties tied to sales per for mance. Novartis also ac quires a non-ex - 

clu sive li cense to IC31 in other ar eas. Intercell will re ceive Euro30-60 mil lion dur ing the de vel op ment 

pe riod in upfront pay ments and milestones, and up to high single-digit royalties tied to sales performance 

for each future license for IC31 in selected areas. 

NIM 811 is a non-immunosuppressive ciclosporin de riv a tive, in de vel op ment for the treat ment of hep a - 

ti tis C vi rus in fec tion. Phase I tri als were on go ing in Eu rope in 2008. 

IC31 is a syn thetic vac cine adjuvant from Intercell (Aus tria) com pris ing the antimicrobial pep tide KLK 

and the immunostimulatory oligodeoxynucleotide ODN1a. The adjuvant in duces both B- and T-cell im - 

mune re sponse. In July 2007, Novartis ac quired ex clu sive rights to use IC 31 to de velop in flu enza vac - 

cines, as well as non-ex clu sive rights to the adjuvant in other ar eas. In June 2008, Intercell re ported the 

re ceipt of a Euro2 mil lion mile stone pay ment from Novartis, trig gered by Novartis’ ini ti a tion of an 

in-house clin i cal trial pro gram to dem on strate the safety and immunogenicity of a sea sonal in flu enza vac - 

cine adjuvanted with Intercell’s IC 31. 



Clin i cal Data: In Feb ru ary 2008, Intercell re ported re sults from a phase I Aus trian trial of the adjuvant 

IC31 in com bi na tion with Novartis’ sea sonal tri va lent in flu enza vac cine Agrippal. In this ran dom ized, 

con trolled trial, 72 healthy adult vol un teers re ceived Agrippal plus one of two dif fer ent con cen tra tions of 

IC31 or Agrippal alone. Most of the vol un teers showed a pre-ex ist ing im mune re sponse against in flu enza 

strains. The trial as sessed the gen eral safety, lo cal tolerability and im mune re sponses elic ited by vac ci na - 

tion with the IC31 adjuvant. Even in vol un teers re ceiv ing the high est dose of IC31 in ad di tion to Agrippal, 

the adjuvant was shown to be safe and well tol er ated com pared with Agrippal alone. Vac ci na tion with 

Agrippal and IC31 led to the in duc tion of vi rus spe cific T-cells and pro tec tive lev els of an ti body responses 

against the three included influenza strains. 

VAC CINE, CYTOMEGALOVIRUS, NOVARTIS: In De cem ber 2008, AlphaVax granted Novartis an ex - 

clu sive li cense to its cytomegalovirus (CMV) vac cine. Un der the terms of the deal, Novartis will be re spon - 

si ble for phase II tri als; AlphaVax will fi nal ize phase I tri als and pro vide clin i cal trial ma te rial for the phase 

II tri als. Reg is tra tion and world wide com mer cial iza tion will be the re spon si bil ity of Novartis. AlphaVax has 

re ceived a $20 mil lion upfront pay ment from Novartis for the CMV pro gram. At the end of phase II tri als, 

Novartis has an op tion to make an eq uity in vest ment for 4 mil lion shares. AlphaVax will be en ti tled to re - 

ceive mile stone pay ments and roy al ties. The agree ment also grants Novartis rights of first ne go ti a tion to 

AlphaVax’s pre clin i cal re spi ra tory syncytial vi rus (RSV) pro gram. Novartis ex pects to be gin phase II tri als 

of the CMV vac cine in 2009. The vac cine is based on an al pha vi rus replicon par ti cle en cod ing CMV 

phosphoprotein 65, immediate early protein 1(IE1) and soluble gB protein. 

VAC CINE, GROUP B STREP TO COC CUS, NOVARTIS: Novartis is de vel op ing a monovalent 

glycoconjugate an ti gen vac cine against Group B Strep to coc cus, for use in the pre ven tion of neo na tal sep - 

sis and mor tal ity caused by Group B Strep to coc cus in fec tion. In De cem ber 2007 a phase I trial of the vac - 

cine ini ti ated in Swit zer land; a sec ond phase I trial be gan in Feb ru ary 2008. Novartis also has a li cense to 

Intercell’s (Aus tria) Group B Strep to coc cus vac cine, which is in preclinical studies. 

VAC CINE, H PYLORI, NOVARTIS: Novartis is de vel op ing a vac cine against Helicobacter pylori. Early 

trial data showed that the vac cine was safe and immunogenic. Phase I tri als were on go ing in 2009. 

VAC CINE, HIV IN FEC TION, NOVARTIS: Novartis is de vel op ing an intranasal vac cine to pre vent HIV 

in fec tion in col lab o ra tion with the Na tional In sti tutes of Health (USA). DNA and pro tein vac cines have 

been eval u ated. Ac cord ing to Novartis, it was in phase I trials in 2008. 

HCV NS3/4A PRO TE ASE IN HIB I TORS, IDENIX: In April 2008, Idenix re ported re sults from pre clin i - 

cal stud ies of its se ries of pro te ase in hib i tors for the treat ment of hep a ti tis C vi rus (HCV) in fec tion. Com - 

pounds in the se ries showed subnanomolar an ti vi ral ac tiv ity against HCV ge no type 1b NS3/4A pro te ase 

tar get and sin gle nanomolar ac tiv ity in the HCV replicon. The agents showed high in vi tro se lec tiv ity and 

did not in hibit hu man cel lu lar pro teas es. The pro te ase in hib i tors showed ac tiv ity against cer tain HCV re - 

sis tant mu tants as so ci ated with first gen er a tion pro te ase in hib i tors in de vel op ment. Data from 

pharmacokinetic stud ies showed ad e quate oral bioavailability and sus tained liver con cen tra tions, in di cat - 

ing po ten tial for once-daily or twice-daily dos ing. Idenix expects to have a candidate from this series in 

clinical development by mid-2009. 




IDX 375: Idenix is de vel op ing IDX 375, a non-nucleoside poly mer ase in hib i tor, as a po ten tial treat ment 

for hep a ti tis C vi rus (HCV) in fec tion. Pre clin i cal stud ies were un der way in the USA in 2008. 






VAC CINE, BORRELIA, NOVARTIS: Novartis is de vel op ing a vac cine against Borrelia for the treat ment 

of Lyme dis ease. Pre clin i cal stud ies are be ing con ducted in Swit zer land. 

VAC CINE, CANDIDA, NOVARTIS: Novartis is de vel op ing a vac cine against Candida in fec tion. Pre clin i - 

cal stud ies are un der way in Swit zer land. 

VAC CINE, CHLAMYDIA, NOVARTIS/INTERCELL: Novartis and Intercell (Aus tria) are de vel op ing a 

vac cine for the pre ven tion of chlamydial in fec tions. Pre clin i cal stud ies are be ing con ducted in Switzerland. 

VAC CINE, GROUP A STREP TO COC CUS, NOVARTIS: A vac cine against Group A Strep to coc cus (GAS) 

was in pre clin i cal stud ies with Novartis in 2008. It is re ported to be sched uled to en ter phase I tri als in 

2010. GAS causes phar yn gi tis, rheu matic fe ver and necrotizing fasicitis. 

VAC CINE, GROUP B STREP TO COC CUS, NOVARTIS/INTERCELL: In De cem ber 2008, Novartis 

signed a cross-li cens ing deal with Intercell (Aus tria), un der which Novartis ac quires ex clu sive rights to 

Intercell’s Group B Strep to coc cus (GBS) vac cine pro gram. In re turn, Intercell re tains and re ceives co-ex - 

clu sive rights to de velop monoclonal an ti bod ies against GBS, and ac quires ad di tional rights to GBS an ti - 

bod ies from Novartis. This agree ment has trig gered pay ment of a rec og ni tion rev e nue from Novartis to 

Intercell, un der a stra te gic part ner ship (signed in 2007). Intercell granted Novartis a li cense op tion to a 

vac cine port fo lio, in clud ing the GBS vaccine program, under the strategic partnership. 

VAC CINE, IN FLU ENZA, DYNAVAX: In July 2008, Dynavax (USA) an nounced a deal with Novartis for 

the de vel op ment, and pos si ble com mer cial iza tion of Dynavax’s uni ver sal in flu enza vac cine. Novartis will 

sup ply Dynavax with tri va lent in flu enza vac cine, a com po nent of Dynavax’s uni ver sal in flu enza vac cine, 

for use in clin i cal tri als and vac cine sales. Novartis has re ceived an ex clu sive op tion to ne go ti ate a joint de - 

vel op ment and com mer cial iza tion agree ment with Dynavax. Dynavax will con duct early stage de vel op - 

ment through a de fined proof-of-con cept. Dynavax would re tain co-com mer cial iza tion rights in the USA 

and re ceive prod uct roy al ties out side the USA if Novartis ex er cises the op tion. If the op tion is not ex er - 

cised, Novartis will con tinue to sup ply Dynavax with tri va lent in flu enza vac cine and Dynavax will have the 

right to con tinue with late-stage de vel op ment and com mer cial iza tion. The uni ver sal in flu enza vac cine 

links Dynavax’s sec ond-gen er a tion TLR9 ag o nist (immunostimulatory DNA se quences (ISS)) to the key 

in flu enza an ti gens nucleoprotein (NP), an an ti gen that var ies lit tle be tween vi ral strains or from year to 

year, and to the extracellular do main of matrix protein 2 (M2e). NP-ISS and M2e-ISS are then added to a 

conventional vaccine to augment its activity. 

VAC CINE, KLEBSIELLA, NOVARTIS/INTERCELL: Novartis and Intercell (Aus tria) are de vel op ing a 

vac cine against Klebsiella pneumoniae for the treat ment of in fec tions caused by this bac te rium. Pre clin i - 

cal stud ies are be ing con ducted in Switzerland. 

VAC CINE, OTITIS ME DIA, NOVARTIS/INTERCELL: Novartis and Intercell are de vel op ing a vac cine 

against in fec tions that af fect the mid dle ear (otitis me dia). Pre clin i cal stud ies are un der way in 

Switzerland. 

VAC CINE, STREP TO COC CUS PNEUMONIAE, NOVARTIS/INTERCELL: Novartis and Intercell (Aus - 

tria) are co-de vel op ing a vac cine against Strep to coc cus pneumoniae in fec tions in chil dren (a cause of 

otitis me dia, pneu mo nia, bacteremia and bac te rial men in gi tis). The vac cine tar gets new and drug-re sis - 

tant strains of S pneumoniae. Novartis’ set of con served pro teins are ex pected to pro vide cov er age 

against a wide range of S pneumoniae strains, in clud ing drug-re sis tant strains. Pre clin i cal stud ies are on - 

go ing in Swit zer land. A phase I trial is planned to begin in 2010. 



Various 

tifacogin TFP 561 V3X, J1X9 III 

oral phosphate binder SBR 759 V3G II 

TIFACOGIN (TFP 561) is a re com bi nant form of tis sue fac tor path way in hib i tor (TFPI), for the treat ment 

of com mu nity-ac quired pneu mo nia (CAP) and sep tic shock. Phase III tri als are un der way in CAP. 

Tifacogin was iso lated as part of a col lab o ra tion with Wash ing ton Uni ver sity Med i cal School, St Louis 

(USA). Pfizer iso lated tifacogin in de pend ently in 1994. Un der a col lab o ra tive agree ment, Pharmacia (now 

Pfizer) and Chiron (now Novartis) were to grant each other li censes to pat ents and col lab o rate as equal 

part ners in all as pects of re search and de vel op ment. Chiron (now Novartis) was to have re spon si bil ity for 

man u fac tur ing the prod uct, and Pfizer was to be re spon si ble for mar ket ing. Fol low ing the merger of 

Pharmacia and Pfizer, Chiron (now Novartis) has ac quired all of Pfizer’s in ter est in tifacogin in re turn for 

royalties paid to Pfizer on sales of the product. 


2010 ($150 mil lion by 2013). 

SBR 759, an oral phos phate binder with po ten tial for the treat ment of hyperphosphatemia in late or 

end stage re nal dis ease pa tients, was in phase II tri als in Eu rope in 2008. 

Li cens ing: In 2005, Novartis ac quired rights to SBR 759 from SeBo (Ger many). Un der the terms of the 

deal, Novartis will de velop, man u fac ture and com mer cial ize SBR 759 for the treat ment of chronic kid ney 

dis ease pa tients or pa tients on di al y sis. These groups of pa tients have re duced phos phate ex cre tion, 

which leads to hyperphosphatemia. Novartis said it has had the po ten tial to of fer di al y sis pa tients a more 

po tent and con ve nient oral treat ment than cur rent ther a pies. It plans to file for approval in 2010. 


2011 ($100 mil lion by 2013). 



Financial Data 

Key Figures 

Share Data: Shares are quoted on the Swiss stock ex change in Zu rich, and the New York Stock Ex - 

change. Shares are also traded on the SEAQ In ter na tional, Lon don. 

Key Fig ures: Key Fig ures for Years end ing De cem ber 31: 

Unit: $ mil lions, ex cept EPS in $ 

2008 2007 2006 2005 2004 

Net Sales 41,459 39,800 37,020 32,212 28,247 

R&D 7,217 6,430 5,321 4,846 4,077 

Pre-Tax Profit 9,499 7,487 7,994 7,265 6,693* 

Net Profit 8,233 11,968 7,202 6,141 5,380* 

EPS ($) 3.59 5.13 3.04 2.63 2.27* 

Total Assets 78,299 75,452 68,008 57,732 52,488 

Shareholder’s Equity 50,437 49,396 41,294 33,164 31,315 

Source: Novartis Jan u ary 2009/Novartis An nual Re ports 

*Note: Re stated (new IFRS rules) 



Sales of Key Prod ucts for years end ing De cem ber 31: 

Unit: $ mil lions 

2008 2007 2006 2005 2004 

Diovan/Co-Diovan 5,740 5,012 4,223 3,676 3,093 

Gleevec/Glivec 3,670 3,050 2,554 2,170 1,634 

Zometa 1,382 1,297 1,283 1,224 1,078 

Femara 1,129 937 719 536 386 

Sandostatin (group) 1,123 1,027 915 896 827 

Neoral/Sandimmun 956 944 918 953 1,011 

Lucentis 886 393 — — — 

Exelon 815 632 525 467 422 

Voltaren (group) 814 747 690 689 638 

Lescol 645 665 725 767 758 

Exjade (group) 531 357 143 — — 

Comtan/Stalevo (group) 502 420 339 278 — 

Tegretol (incl. CR/XR) 451 413 391 393 396 

Ritalin/Focalin (group) 440 375 330 — — 

Exforge 406 — — — — 

Foradil 387 362 331 332 321 

Lotrel 386 748 1,352 1,075 920 

Trileptal 332 692 721 615 518 

Tobramycin 295 273 177 — — 

Myfortic 290 — — — — 




Sales From Continuing Operations by Business Sector for years ending 

December 31: 


2008 2007 2006 

Pharmaceuticals 26,331 24,025 22,576 

Vaccines and Diagnostics 1,759 1,452 956 

Sandoz 7,557 7,169 5,959 

Consumer Health 5,812 5,426 6,540 

TOTAL 41,459 38,072 36,031 


Pharmaceutical Sales by Therapy Class for years ending December 31: 


2008* 2007 

Cardiovascular and Metabolism 8,183 7,405 

Oncology 8,211 6,951 

Neuroscience and Ophthalmics 4,605 4,347 

Immunology and Infectious Diseases 2,954 2,993 

Respiratory 1,084 959 

Ophthalmics, Dermatology, Gastrointestinal &Urology — 2,152 

Arthritis/Bone — 1,574 

Infectious Diseases, Transplantation & Immunology — 1,639 

TOTAL 26,331 24,025 

Source: Novartis Jan u ary 2009 

*Note: For 2008 Novartis re ported sales for five ma jor ther a peu tic ar eas at the be gin ning of 2009. 



Sales by Geographic Region for years ending December 31: 


2008 2007 2006 2005 2004 

Switzerland 531 448 412 376 340 

USA 12,861 14,238 14,998 12,587 11,258 

Germany 4,114 3,840 3,187 2,470 1,596 

Japan 2,987 2,559 2,464 2,591 2,424 

France 2,284 2,080 1,763 1,856 1,692 

UK 1,207 1,144 1,037 924 979 

Austria 394 356 308 275 245 

China* 456 — — — — 

Slovenia* 97 — — — — 

Other 16,528 15,135 12,757 11,007 9,588 

TOTAL 41,459 39,800 37,020 32,212 28,247 

Source: Novartis An nual Re port 2008/Novartis Jan u ary 2009 

*Note: Fig ures for China and Slovenia first re ported in 2008 



Analyst Figures 

Financial analysts have provided the following forecasts for Novartis: 

COWEN & CO (January 2009) 

Key Figures for years ending December 31: 


2008 2009(E) 2010(E) 2011(E) 2012(E) 

Sales 41,459 43,110 49,775 54,245 58,590 

EPS (continuing) 3.57 3.85 4.35 4.30 3.70 



COWEN & CO (August 2008) 

Sales of Key Marketed Products for years ending December 31: 


2007 2008(E) 2009(E) 2010(E) 2011(E) 2012(E) 2013(E) 

Diovan 5,012 5,985 6,405 6,400 4,650 3,200 1,500 

Exforge 103 450 750 950 1,050 900 700 

Lotrel 748 375 320 200 150 100 50 

Lescol 665 640 550 450 300 200 100 

Galvus 8 35 40 60 80 100 120 

Total Cardiovascular 7,405 8,485 9,175 9,250 7,585 6,270 4,705 

Glivec 3,050 3,820 4,305 4,550 4,750 4,950 5,100 

Tasigna — 65 130 200 250 300 400 

Zometa 1,297 1,370 1,385 1,200 1,000 900 750 

Sandostatin 1,027 1,165 1,205 1,250 1,300 1,100 600 

Femara 937 1,165 1,355 1,400 1,000 500 300 

Exjade 357 515 625 675 725 775 825 

Total Oncology 6,951 8,420 9,425 9,785 9,715 9,655 9,435 

Trileptal 692 335 300 250 200 200 150 

Exelon/Patch 632 790 885 950 975 900 800 

Tegretol 413 485 495 505 515 525 535 

Comtan Group 420 515 575 650 700 750 350 

Ritalin Group 375 415 430 445 460 475 490 

Total Neuroscience 3,345 3,345 3,530 3,670 3,835 4,010 3,660 

Foradil 362 415 430 400 350 300 250 

Xolair 140 190 200 225 250 275 300 

TOBI (to be replaced by dry 

powder product in 2011) 273 295 310 180 — — — 

TMB 100 (2nd generation 

TOBI dry powder) — — — 150 345 360 370 

Total Respiratory 959 1,090 1,190 1,305 1,470 1,935 2,395 

Lucentis 397 975 1,220 1,350 1,400 1,450 1,500 

Enablex 179 205 225 235 245 255 265 

Zelnorm 88 15 20 10 10 10 10 

Total Ophthalmics/GI/Urinary1,381 1,755 2,085 2,265 2,375 2,485 2,570 

Voltaren 749 875 920 940 950 960 970 

Aclasta 41 300 580 620 650 675 550 

Prexige 91 45 40 40 40 40 40 

Total Metabolic/Pain 1,574 1,745 2,060 2,160 2,245 2,325 2,130 

Neoral/Sandimmun 944 1,030 1,005 985 955 925 900 

Cubicin 14 20 40 50 75 100 125 

Elidel 176 155 130 120 110 100 100 

Total Immunology/ 

Infection 2,410 2,650 2,670 2,855 3,100 3,355 3,600 



Sales of Key R&D Pipeline Products for years ending December 31: 


Cardiovascular 

2007 2008(E) 2009(E) 2010(E) 2011(E) 2012(E) 2013(E) 

SPP 635 — — — — — 50 100 

SPP 301 (avosentan) — — — — — 50 100 

SPP 200 (pegmusirudin) — — — — — 50 100 

VNP 489 — — — — — 50 100 

LCZ 969 — — — — 25 50 75 

Oncology 

Afinitor (RAD 001) — — 80 150 200 250 300 

LBH 589 (panobinostat) — — — 10 30 60 80 

SOM 230 (pasireotide) — — — — 50 75 100 

EPO 906 (patupilone) — — — — 50 75 100 

LBQ 707 (gimatecan) — — — — — 50 100 

PKC 412 (midostaurin) — — — — — 50 75 

TKI 258 (dovinitib) — — — — — 50 75 

ASA 404 (vadimezam) — — — — — 50 100 

LBY 135 — — — — — 50 75 

HCD 122 — — — — — 50 75 

Neuroscience 

FTY 720 (fingolimod) — — — 25 150 300 450 

Extavia — 25 120 150 175 185 195 

AFQ 056 — — — — — 50 100 

ATI 355 — — — — — 25 50 

Respiratory 

TMB 100 (2nd generation 

TOBI dry powder) — — — 150 345 360 370 

indacaterol (QAB 149) — - 50 100 150 250 300 

QMF 149 (indacaterol + 

mometasone) — — — — 100 200 300 

NIC 002 (nicotine withdrawal 

vaccine) — — — — — 100 200 

QAT 370 — — — — — 50 100 

QVA 149 — — — — — 50 100 

NVA 237 — — — — — 50 100 

MFF 258 (formoterol + mometasone) — — — 50 75 100 125 

QAX 028 — — — — — — 50 

QAE 397 — — — — — — 50 



Metabolic/Pain 

SBR 759 — — — — 50 75 100 

SMC 021 — — — — — 25 50 

Immunology/Infection 2,410 2,650 2,670 2,855 3,100 3,355 3,600 

Myfortic — 320 430 450 475 500 525 

ACZ 885 (canakinumab) — — — 35 125 150 175 

Certican — — — 50 75 100 150 

tifacogin — — — 50 100 125 150 

Albuferon — — — 50 75 100 125 

Aurograb — — — — — 50 75 

Mycograb — — — 25 50 75 100 

AEB 071 — — — — — 25 50 

BCT 194 — — — — — 50 75 

Note: De vel op ment of Aurograb has now been dis con tin ued. 



MORGAN STANLEY (January 2009) 

Key Figures for years ending December 31: 


2007 2008(E) 2009(E) 2010(E) 2011(E) 2012(E) 2013(E) 2014(E) 

Sales 38,072 41,683 43,390 53,528 56,938 58,613 58,345 57,643 

R&D 6,430 7,243 7,198 8,030 8,198 8,300 8,351 8,168 

Pre-Tax Profit 7,487 9,828 10,861 12,092 13,873 14,549 14,090 13,838 

Net Profit 6,518 8,391 9,063 9,548 10,952 11,454 11,010 10,721 

EPS (continuing) 2.81 3.70 4.00 4.22 4.86 5.13 5.01 4.96 

Sales of Key Products for years ending December 31: 


2007 2008(E) 2009(E) 2010(E) 2011(E) 2012(E) 2013(E) 2014(E) 

Diovan 5,012 5,748 5,819 5,834 5,130 3,933 1,629 1,264 

Exforge 102 431 676 775 874 874 593 230 

Lotrel 748 376 182 146 116 93 75 67 

Lescol 665 645 612 600 588 382 229 183 

Tekturna/Diovan + 

Tekturna FDC 40 159 291 387 449 493 514 532 

Other Strategic 34 30 32 35 39 43 47 49 

Mature Products 804 835 768 729 693 658 625 594 

Cardiovascular 7,405 8,224 8,379 8,506 7,888 6,476 3,711 2,919 

Glivec 3,050 3,688 3,902 4,234 4,441 4,655 4,864 4,973 

Zometa 1,297 1,403 1,553 1,786 1,964 2,063 1,287 1,030 

Sandostatin 1,027 1,139 1,142 1,024 929 857 802 380 

Femara 937 1,136 1,238 1,362 1,409 774 619 508 

Exjade 357 519 627 721 794 833 858 901 

Other Oncology 283 249 234 227 220 214 207 201 

Oncology 6,951 8,290 9,074 10,109 10,890 10,653 9,958 9,313 

Trileptal 692 325 236 177 133 100 75 75 

Exelon 632 812 841 891 936 749 599 479 

Tegretol 413 464 427 405 385 366 348 330 

Comtan/Stalevo 420 500 532 575 609 640 672 336 

Ritalin 375 428 456 492 522 548 575 547 



CNS 3,345 3,550 3,562 3,643 3,722 3,579 3,488 2,928 

Foradil 362 400 399 411 423 436 449 462 

Xolair 140 204 217 243 256 256 256 256 

TOBI 273 288 293 308 323 339 356 356 





Respiratory 959 1,089 1,104 1,163 1,208 1,243 1,280 1,293 

Zelnorm 88 13 13 13 13 13 13 13 

Visudyne 179 129 106 90 86 81 77 74 

Lucentis 393 904 1,006 1,106 1,162 1,220 1,281 1,345 

Elidel 176 157 145 137 131 124 118 112 

Enablex 179 210 224 242 254 267 280 288 


Lamisil 595 266 202 162 130 104 84 79 


Ophthalmics/ 

Dermatology/GI 2,152 2,020 2,037 2,101 2,132 2,173 2,223 2,282 

Galvus — 50 80 130 250 340 430 473 

Prexige 91 26 26 26 26 26 26 26 


Miacalcic 281 253 232 221 210 199 189 180 

Voltaren 747 821 755 717 681 647 615 584 


Arthritis/Bone/Pain 1,571 1,639 1,673 1,872 2,211 2,341 2,384 1,472 

Neoral/Sandimmun 944 960 869 826 784 745 708 672 

Sebivo (telbivudine) 88 230 346 451 509 543 572 600 

Famvir 236 100 94 92 89 86 84 81 



Infection/ 

Transplantation/ 

Immunology 1,642 1,608 1,609 1,662 1,670 1,657 1,642 1,626 

PIPELINE PRODUCTS — — 142 551 1,355 2,444 3,415 4,105 

TOTAL PHARMA 24,025 26,421 27,582 29,606 31,077 30,566 28,101 25,939 

Vaccines and Diagnostics 1,452 1,720 1,837 2,248 2,908 3,818 4,754 5,125 

Sandoz 7,169 7,655 7,820 8,308 8,807 9,247 9,617 9,906 

Consumer Health 

(ongoing) 5,426 5,886 6,152 6,521 6,782 7,053 7,335 7,555 

TOTAL SALES 

(reported) 39,800 41,683 43,390 53,528 56,938 58,613 58,345 57,643 



IMS Sales Data 

Pharmaceutical Sales by Geographical Region and Leading Countries 

Country Share 

of Regional 

Corporate Sales 

% 

Percentage 

Growth Sep 

07/Sep 08 

USD USD FIXED 

RATE 

TOTAL SALES 100.0 8 1 

EUROPE 41.6 22 8 

GERMANY 28.1 22 8 

FRANCE 14.8 21 7 

ITALY 8.6 22 8 

SPAIN 7.8 23 9 

UNITED KINGDOM 5.8 8 8 

NORTH AMERICA 37.1 -10 -11 

U.S.A. 92.6 -12 -12 

CANADA 7.4 22 11 

ASIA, AFRICA & AUSTRALASIA 16.2 20 11 

JAPAN 44.5 19 7 

TURKEY 14.0 23 10 

AUSTRALIA 8.5 40 25 

KOREA 5.5 9 15 

CHINA HOSPITAL 3.8 29 19 

LATIN AMERICA 5.0 25 15 

BRAZIL RETAIL 44.5 44 21 

MEXICO RETAIL 21.2 2 -1 

VENEZUELA RETAIL 11.2 52 52 

ARGENTINA RETAIL 6.1 14 14 

PUERTO RICO 5.9 3 3 

The com pany’s phar ma ceu ti cal sales are an a lyzed in terms of geo graph ical re gion, and within each re - 

gion the ma jor coun tries pre sented. Sales data cov ers the twelve months to Sep tem ber 2008. See Ap - 

pen dix for coun try universe sourced. 

Sales and growth for the au dited Latin Amer i can coun tries are pre sented in US dol lars only. The de ci sion 

for con ver sion to US dol lars was due to ex ces sive in fla tion and sub se quent de val u a tions lead ing to both 

lo cal cur rency and ex change rates ex ceed ing the field sizes avail able for them on the MIDAS database. 

Novartis Total Sales by Top Five Markets 

Source: IMS Health 

Others 

37% 

Japan 

7% 

Italy 

4% 

France 

6% 

Sales by Top 5 Markets 

USA 

34% 

Germany 

12% 



Pharmaceutical Sales by Country and Subsidiary 

Share of 

Regional 


% 

Percentage 

Growth Sep 

07/Sep 08 

USD USD FIXED 

RATE 


U.S.A. 34.4 -12 -12 

NOVARTIS RX 73.0 -11 -11 

SANDOZ 21.9 -11 -11 

NOVARTIS CONS HLTH 2.9 -8 -8 

NOVARTIS VACCINE 1.6 -46 -46 

NOVARTIS VISION 0.6 7 7 

GERMANY 11.7 22 8 

NOVARTIS PHARMA 39.8 26 12 

HEXAL 36.4 26 12 

NOVARTIS VACCINES 7.4 -6 -17 

1A PHARMA 5.8 34 19 

SANDOZ 5.4 14 1 

NOVARTIS CONS.HEAL 5.2 17 4 

NOVARTIS/P.FABRE 0.1 7 -5 

JAPAN 7.2 19 7 

NOVARTIS PHARMA JA 98.8 18 7 

SANDOZ JAPAN 1.2 29 16 

FRANCE 6.2 21 7 


SANDOZ 19.7 23 9 

NOVARTIS SANTE FAM 4.5 10 -3 

CHIRON FRANCE 0.8 32 16 

NOVARTIS VACC&DIAG 0.1 383 333 

DIETETIQ ET SANTE 0.1 -4 -15 

ITALY 3.6 22 8 

NOVARTIS FARMA 70.4 19 5 

NOVARTIS CONS.HEAL 14.8 16 2 

SANDOZ 6.1 51 34 

HEXAL 5.6 38 22 

NOVARTIS VACCINES 2.8 90 68 

POZZI 0.2 -41 -48 

SCLAVO DIAGNOSTICS 0.1 40 24 

SPAIN 3.2 23 9 

NOVARTIS 82.3 25 11 

NOVARTIS CONS HEAL 6.5 20 6 

SANDOZ FARMACEUTIC 5.9 25 11 

BEXAL FARMACEUTIC 4.6 -2 -13 

ACOST COMER GEN PH 0.6 23 9 

CANADA 2.7 22 11 


SANDOZ CANADA INC 29.1 38 26 

NOVARTIS CON HEALT 6.6 7 -3 

CIBA VISION OPTICS 0.7 48 35 

UNITED KINGDOM 2.4 8 8 

NOVARTIS PHARM UK 82.9 15 15 

SANDOZ 10.0 -16 -17 

NOVARTIS CONSUMER 5.7 -17 -17 

CHIRON UK 0.7 30 29 

CIBAVISION 0.4 29 29 

CHIRON VACC EVANS 0.3 17 17 



This ta ble shows the break down of the com pany’s phar ma ceu ti cal sales in terms of lead ing coun tries and 

sub sid iar ies. Sta tis tics for coun try share of cor po rate rev e nue, sub sid iary share of coun try rev e nue, US 

dol lar and US dol lar fixed rate growth over the pre vi ous twelve month pe riod are pre sented. Sales data 

cov ers the pe riod for the twelve months to September 2008. 

All of the sub sid iar ies men tioned above are 100%-owned by Novartis ex cept Novartis/P.Fabre, Ger many 

(50%-owned by Pi erre Fabre, France). Sales for a sub sid iary are al lo cated to the cor po ra tion with the ma - 

jor ity shareholding. In re la tion ships where there is a 50:50 shareholding, how ever, sales will con tinue to 

be split 50:50 be tween the two owning corporations. 

Pharmaceuticals: Top Five Third Level Therapeutic Classes 

ATC Therapeutic 

Class 

Description 

US 

Dollar 

Sales 

(‘000s) 

Share of 

Worldwide 


% 

Percentage 

Growth Sep 

07/Sep 08 

USD USD FIXED 

RATE 

TOTAL SALES 36296737 100.0 8 1 

1 C9C ANGIOTEN-II ANTAG, PLAIN 3616125 10.0 19 12 

2 L1X ALL OTH. ANTINEOPLASTICS 3149187 8.7 23 14 

3 C9D ANGIOTEN-II ANTAG, COMB 2815218 7.8 34 28 

4 M5B BONE CALCIUM REGULATORS 1515000 4.2 19 13 

5 L4A IMMUNOSUPPRESSIVE 

AGENTS 1240800 3.4 14 5 

This ta ble shows the com pany’s top five third level ther a peu tic classes. Sales data cov ers the twelve 

month pe riod to Sep tem ber 2008. Sta tis tics for third-level ther a peu tic class share of cor po rate rev e nue, 

US dol lar and US dol lar fixed rate growth over the pre vi ous twelve month pe riod are presented. 

The lead ing five ther a peu tic classes ac count for 34.1% of cor po rate rev e nue. 

Pharmaceuticals: Leading International Products 

International 

Products 

Share of 

Worldwide 


% 

Percentage 

Growth Sep 

07/Sep 08 

USD USD FIXED 

RATE 


1 DIOVAN 9.9 18 12 

2 GLIVEC 8.5 21 12 

3 CO-DIOVAN 6.8 20 14 

4 ZOMETA 3.9 19 14 

5 VOLTAREN 3.4 14 4 

6 FEMARA 2.8 28 21 

7 SANDOSTATIN 2.7 11 5 

8 SANDIMMUN 2.4 6 -3 

9 EXELON 2.1 31 22 

10 LUCENTIS 1.9 354 312 



This ta ble shows the com pany’s lead ing ten phar ma ceu ti cal prod ucts. For each prod uct, its per cent age 

share of cor po rate rev e nue and US dol lar and US dol lar fixed rate growth are shown. In this study, in ter - 

na tional prod ucts are used. The con cept of the in ter na tional prod uct was de vised for IMS’s in ter na tional 

da ta base MI DAS, to en able us ers to eval u ate sales of a prod uct in ter na tion ally, even if the prod uct is 

known by dif fer ent names in dif fer ent coun tries. Prod ucts are linked in ter na tion ally if at least two of the 

fol low ing three char ac ter is tics are the same as in coun try of first launch: brand name; marketing 

corporation; active ingredients. 

The top ten in ter na tional prod ucts ac counted for 44.4% of cor po rate rev e nue. 

Pharmaceutical Sales Analysis By Product Age 

US 

Dollar 

Sales 

(‘000s) 

Share of 

Worldwide 


% 

Percentage 

Growth Sep 

07/Sep 08 

USD USD FIXED 

RATE 

TOTAL SALES 36296737 100.0 8 1 

PRODS 1-2 YEARS 2969278 8.2 194 184 

PRODS 3-5 YEARS 4524839 12.5 13 5 

PRODS 6-10 YEARS 12086224 33.3 3 -3 

PRODS 11 YEARS 16716396 46.1 -2 -7 

This ta ble an a lyzes com pany sales by prod uct age, as sess ing sales in terms of new prod ucts, es tab lished 

prod ucts, ma ture prod ucts and old prod ucts. A new prod uct is de fined as a new launch of an ex ist ing 

prod uct, a new chem i cal en tity or a com bi na tion prod uct in an in di vid ual coun try over the last two years 

to September 2008. 



Appendix 

All ta bles in this sec tion are based on the fol low ing coun try uni verse. Al though all uni verse coun tries 

are se lected, in di vid ual cor po ra tions may not op er ate in all mar kets. In most cases, sales data cov ers 

the twelve-month pe riod to September 2008. 

Audited Universes 

North America Europe Asia, Africa & Australasia Latin America 

Canada* Austria* Algeria Argentina 

United States** Belgium* Australia* Brazil 

Belorussia Bangladesh Central America*** 

Bulgaria* China Hospital Chile 

Croatia Egypt Colombia 

Czech Republic* French W Africa Dominican Republic 

Denmark Hong Kong Ecuador 

Finland* India Mexico 

France* Indonesia* Peru 

Germany* Israel Puerto Rico* 

Greece Japan* Uruguay 

Hungary* Jordan Venezuela 

Ireland Korea* 

Italy* Korea Clinic 

Latvia* Kuwait 

Lithuania* Lebanon 

Luxembourg Malaysia 

Netherlands Xponent Morocco 

Norway New Zealand* 

Poland* Pakistan 

Portugal Philippines* 

Russian Federation* Saudi Arabia 

Spain* South Africa* 

Slovak Republic* Singapore 

Slovenia Taiwan* 

Sweden Thailand* 

Switzerland* Tunisia 

Ukraine Turkey* 

United Kingdom* United Arab Emirates 

*Note: In cludes hos pi tal sales in ad di tion to re tail sales. 

**Note: USA in cludes hos pi tal, clinic and mail or der sales, re tail sales, HMO, long term care, home health 

care, foodstore and ‘mis cel la neous’ sales (pris ons, uni ver si ties etc). 

***Note: Cen tral Amer ica = Costa Rica, Gua te mala, Hon du ras, El Sal va dor, Nic a ra gua and Panama. 



Employee Data 

The company had the following number of employees for years ending December 31: 

2003 78,541 

2004 81,392 

2005 90,924 

2006 100,735 

2007 98,200 

2008 96,700 

Source: Novartis An nual Re port 2008 



Licensing/Co-Marketing Agreements 

Marketed Products 

Product Class Date Terms of Agreement 

Exforge (valsartan + 

amlodipine) 

C 2009 Co-promotion agreement for France with Ipsen. 

Galvus (vildagliptin) A 2008 Novartis Korea and HANDOK signed a co-promotion deal 

for South Korea. 

Simulect (basiliximab) L 2006 Cerimon acquired exclusive worldwide rights to 

basiliximab for the treatment of inflammatory bowel 

disease. 

Lescol (fluvastatin) and 

Lescol XL (fluvastatin 

extended release) 

C 1993- 

2008 

Elidel (pimecrolimus) L 2004- 

6 

Was co-marketed with Mitsubishi Tanabe in Japan under 

the terms of a 1993 deal, but this deal was terminated in 

2008. AstraZeneca has rights in a number of markets. In 

2001, German rights were licensed to Klinge and Fournier, 

which is now part of Solvay. In 2006, Biovail licensed-in 

rights to market Lescol and Lescol XL in Canada until 

2008, and LG Pharma agreed to co-market the product in 

South Korea with Novartis. 

In 2004, Avantec Vascular obtained an option to license 

pimecrolimus for use in its drug-eluting stents. In 2006, 

Conor Medsystems obtained worldwide, non-exclusive 

license to pimecrolimus for use with its next-generation 

controlled vascular drug delivery technologies. 

Enablex (darifenacin) G 2005 Deal with Procter & Gamble for the co-promotion and 

further development of Enablex extended release tablets 

for the treatment of overactive bladder in the USA. 

Cibacen 

(benazepril)/Cibadrex 

(benazepril + HCT) 

C 2005 Meda AB granted exclusive rights in most European 

markets. 

Cubicin (daptomycin) J 2003 Chiron (now part of Novartis) acquired rights in Western 

Europe, Eastern Europe, the Middle East, Australia, New 

Zealand, Central America, South America and India. 

Certican (everolimus) L 2002 Novartis licensed everolimus to Guidant for use in 

Guidant’s stents. Later revised to give Guidant exclusivity, 

and the right to grant sub-licenses. 




Foradil Aerolizer 

(formoterol fumarate) 

Zaditen (ketotifen 

fumarate) 

Focalin 

(dexmethylphenidate) 

Estraderm MX/Estraderm 

TTS (17 beta estradiol) 

Famvir (famciclovir) and 

Vectavir/Denavir 

(penciclovir) 

Stalevo (entacapone + 

levodopa + carbidopa) 

Exelon (rivastigmine) N 1999- 

2005 

L 2002 Schering-Plough acquired US marketing & distribution 

rights for an upfront payment, milestones & royalties. 

N/C/R 2002 Canadian rights licensed to PanGeo Pharma. 

N 2000 Novartis licensed-in rights from Celgene for development 

and commercialization worldwide, outside Canada. 

G 2000 Japanese marketing transferred to Kissei. 

J 2000 Licensed-in from GlaxoSmithKline for worldwide markets. 

N 2000 Co-promotion and co-marketing deal with Orion. 

Originally licensed-in from Orion in 1998. 

In 2005, Novartis and Ono agreed to co-develop and 

co-market the rivastigmine transdermal patch in Japan. 

Rivastigmine was licensed-out to Esteve for co-marketing 

in Spain in 1999 by Novartis. Exteva co-markets it in 

Spain as Prometax. 

Diovan (valsartan) C 1999 Schwarz acquired co-marketing rights in Germany. 

Menarini co-markets in Italy. Novartis and Choong-Wae 

have a co-promotion agreement for South Korea. 

Vivelle (17 beta estradiol 

patch) 

G 1999 Novartis acquired rights in Europe and certain other 

countries. In 1998, Novartis and Noven established a jv, 

Vivelle Ventures (became Novogyne Pharmaceuticals in 

1999), to market Vivelle in North America. Originally 

licensed out by Noven to Ciba for marketing in North 

America in 1991. 

Visudyne (verteporfin) S 1995 Verteporfin was discovered at the University of British 

Columbia and was co-developed by QLT 

PhotoTherapeutics and CIBA Vision. The University of 

British Colombia licensed verteporfin to QLT, which 

sublicensed it to CIBA Vision for worldwide 

co-development and co-marketing. The deal was 

expanded in 2000. 

Femara (letrozole) L 1994 Novartis and Chugai agreed to co-market in Japan. 




Starlix (nateglinide) A 1994 Licensed-in from Ajinomoto for marketing worldwide 

(except Japan, South Korea, Taiwan, China, the UK, and 

Ireland). In 1999, it acquired rights in the UK and Ireland. 

In 2000, Merck KGaA acquired co-promotion and 

co-marketing rights. 

Sandimmun (ciclosporin) L 1993 Licensed-out to Allergan for topical ophthalmic uses 

worldwide outside Japan and certain other Asian 

countries. 

Foradil (formoterol) R 1986 Licensed-in from Yamanouchi (now Astellas) by Ciba for 

all markets outside Japan. 

Xolair (omalizumab) R 1990 Novartis and Genentech share co-marketing rights in the 

USA. 

Lopresor/SR (metoprolol) C N/A Licensed-in from AstraZeneca for exclusive marketing in 

the USA, and non-exclusive marketing in other countries. 

Lotrel (amlodipine + 

benazepril) 

R&D Pipeline Products 

C N/A Pfizer granted Novartis rights to use amlodipine in 

combination with Novartis’ benazepril. 


IDX 899 J 2009 GlaxoSmithKline acquired exclusive global rights to 

Idenix’s reverse transcriptase inhibitor IDX 899. Idenoix 

is majority-owned by Novartis. All development of IDX 

899 and associated costs will be assumed by GSK. Upon 

successful commercialization, Idenix will receive double 

digit, tiered royalties on worldwide sales. 

elinogrel B 2009 Exclusive worldwide rights licensed-in from Portola 

Pharmaceuticals. Novartis will have responsibility for 

phase III trials, manufacturing and commercialization. 

Portola has an option to co-promote elinogrel in the US in 

the hospital and specialty markets and an option to 

co-fund phase III trials and other development activities 

in return for additional royalties. 




PI 2301 N 2009 Peptimmune granted Novartis an exclusive option to 

exclusive worldwide development and commercialization 

rights. If Novartis chooses to exercise this option, it 

would assume responsibility for the clinical development, 

manufacturing and marketing of the agent globally, and 

all associated expenses. Novartis would make payments 

to Peptimmune (could be in excess of $500 m) upon 

exercising the option and achievement of certain 

development, regulatory and commercial milestones. 

Novartis would also pay royalties on product sales to 

Peptimmune. PI 2301 is in development for use in MS. 

CMV and RSV vaccines J 2008 AlphaVax granted Novartis an exclusive license to a 

cytomegalovirus (CMV) vaccine. The deal also gives 

Novartis rights of first negotiation to AlphaVax’s 

preclinical respiratory syncytial virus (RSV) program. 

HCD 122 L 2008 Restructured agreement between Novartis and XOMA for 

HCD 122 and five other projects. Novartis will make an 

upfront payment of $6.2m; fully fund all future R&D 

expenses; pay potential milestones of up to $14m and 

double-digit royalty rates for two programs, including 

HCD 122; and provide XOMA with options to develop or 

receive royalties on four additional programs that are 

pending selection. HCD 122 derives from an original 2004 

agreement between Chiron and XOMA to develop 

multiple antibody products to treat cancer. 

vaccine, influenza, 

Dynavax 

J 2008 Dynavax signed an agreement with Novartis Vaccines 

and Diagnostics for the development, and possible 

commercialization of Dynavax’s universal influenza 

vaccine. 

BA 058 M 2007 An option to obtain an exclusive worldwide license to 

develop and commercialize Radius’ osteoporosis drug 

candidate. 

Nicotine-Qbeta (vaccine, 

nicotine withdrawal, 

Cytos) 

N 2007 Licensed-in from Cytos for markets worldwide. 

Vaccines J 2007 Alliance with Intercell relating to the development of a 

number of vaccines for infectious diseases. Novartis 

gained rights to Group B Streptococcus vaccine program 

in December 2008. 

ASA 404 L 2007 Licensed-in from Antisoma for global markets. 




Xyotax (drug delivery 

system, poliglumex 

paclitaxel) 

indacaterol + 

mometasone (QMF 149) 

Albuferon (albinterferon 

alfa-2b) 

L 2006 Licensed-in from Cell Therapeutics. Novartis agreed to 

take an 8% stake in the firm and also has an option to 

license pixantrone. 

R 2006 Collaboration with Schering-Plough to develop a fixed 

combination of the corticosteroid mometasone and 

indacaterol, as a once-daily inhaled treatment for asthma 

and COPD. 

J 2006 Human Genome Sciences granted Novartis rights to 

co-market in the USA and rights to market the product in 

territories outside the USA. Clinical development costs 

will be shared. HGS will receive an upfront payment of 

$45 million as well as clinical development, commercial 

milestone and other payments of up to $507.5 million. 

Y 39983 S 2005 Licensed rights to Y 39983 from Senju. 

AT 9311/AT 7519 L 2005 Licensed global rights to AT 9311 from Astex, plus an 

option to license AT 7519. 

SBR 759 V 2005 Licensed in worldwide rights from SeBo. 

NM 100060 J 2005 Exclusive global licensing deal with NexMed for NexMed’s 

proprietary NM 100060 terbinafine nail lacquer treatment 

for onychomycosis. 

RSV 604 J 2005 Novartis agreed to develop, commercialize and fund all 

future work related to Arrow’s RSV 604. Rights to 

back-up compounds to RSV 604 are included in the deal 

plus a right of first negotiation on follow-up compounds 

with different chemistry, in development with Arrow (now 

part of AstraZeneca). 

drug delivery system, 

inhaled glycopyrronium 

bromide 

R 2005 Licensed-in from Ventura and Arakis (now Sosei). 




QAX 935 R 2005 QAX 935 is a Toll-like receptor 9 (TLR9) agonist 

discovered through a research collaboration between 

Idera (formerly Hybridon) and Novartis. It is now being 

co-developed by Novartis and Idera. In 2005, Hybridon 

and Novartis entered into a deal for the discovery, 

optimization, development and commercialization of TLR9 

immune modulatory oligonucleotide candidates, based on 

Hybridon’s proprietary Immune Modulatory 

Oligonucleotide (IMO) technology platform, for the 

treatment of asthma and allergy. In March 2007, Idera 

and Novartis extended the term of the research phase of 

their collaboration by one year. Novartis has in-licensed 

the exclusive rights to QAX 935 from Idera. 

formoterol + mometasone R 2003 Schering-Plough and Novartis agreed to co-develop MFF 

258, a combination of Schering-Plough’s corticosteroid 

mometasone and the Novartis beta2 agonist formoterol. 

gimatecan L 2003 Gained exclusive rights worldwide and semi-exclusive 

rights in Italy to Sigma-Tau’s oral topoisomerase I 

inhibitor. 

fingolimod (FTY 720) L 1997 Exclusive worldwide rights outside Japan licensed-in from 

Yoshitomi (now Mitsubishi Tanabe Pharma). 

General Research Collaborations 

Company/Organization Date Area of 

Collaboration 

Terms of Agreement 

FORMA 2009 Inhibitors in oncology Option and license agreement, through 

the Novartis Option Fund. FORMA will use 

its biology- and chemistry-based platform 

to develop inhibitors of an undisclosed 

protein-protein interaction cancer target. 

FORMA will receive an upfront fee, and is 

entitled to potential milestone payments of 

over $200 m in total and royalties. Further 

terms of the agreement were not 

disclosed. 




Collaboration 

Ascent Therapeutics 2008 Pepducin drug 

candidates against a 

specific G-protein 

coupled receptor 

(GPCR) target 

Evotec 2008 Small molecule 

therapeutics for 

central nervous 

system (CNS) 

Egalet 2008 Parvulet drug 

delivery technology 



Licensing option agreement through the 

Novartis Option Fund. AT will develop 

Pepducin drug candidates against a 

specific GPCR target. Agreement includes 

an upfront fee, potential milestone 

payments (possible $200m), and royalties. 

AT’s Pepducin technology comprises a 

short peptide derived from a GPCR 

intracellular loop tethered to a 

hydrophobic moiety. The technology is 

capable of inhibiting or activating multiple 

signals in GPCR pathways; this is a 

mechanism for disrupting GPCR signal 

transduction from inside the cell surface, 

facilitating the treatment of a wide range 

of conditions. 

Research collaboration for an initial three 

years. Evotec will use its drug discovery 

platform to advance a drug discovery 

program against a target nominated by 

Novartis from discovery into the clinic. The 

programs will be developed to the 

preclinical stage by Evotec; Novartis will 

then be responsible for all clinical 

development activities, manufacture and 

commercialization of the compounds. 

Evotec is eligible for an upfront payment, 

milestone payments which could total 

more than $28 m, and royalties. 

Egalet (Denmark) granted Sandoz (part of 

Novartis) a worldwide license to Parvulet, 

an oral drug delivery technology 

comprising a sealed dispensing spoon 

containing the relevant drug in a 

formulation requiring hydration. Sandoz 

will utilize Parvulet to develop a pediatric 

formulation of an undisclosed compound. 

Under the terms of the deal Egalet will 

receive an upfront payment, a milestone 

payment and royalties from sales.



Collaboration 

BioWa 2008 POTELLIGENT 

technology 

Global Alliance for TB 

Drug Development 


BioWa signed a deal with Novartis relating 

to its patented POTELLIGENT technology. 

Novartis will have access to the 

POTELLIGENT platform for the R&D, 

manufacture and commercialization of 

antibody-dependent cellular cytotoxicity 

(ADCC) enhanced antibodies for an 

undisclosed number of targets. Novartis 

will pay BioWa license fees and 

development milestone payments. BioWa 

will receive royalties on any products 

developed by Novartis. BioWa’s 

POTELLIGENT technology comprises an 

FUT8 knockout CHO cell line that enables 

the production of fucose-deficient 

monoclonal antibodies. 

2008 TB The Novartis Institute for Tropical Diseases 

(NITD) and the Global Alliance for TB Drug 

Development are collaborating on a 5-year 

program to develop agents for the 

treatment of tuberculosis (TB), including 

drug-resistant TB. The NITD and the 

Global Alliance for TB Drug Development 

will share information on new and ongoing 

TB drug discovery projects. The deal 

allows for future collaborative 

development of antibiotic compounds. 

Discovery stage research is under way. 

The NITD is a private-public partnership 

between Novartis and the Singapore 

Economic Development Board. 

MorphoSys 2007 Drug discovery and 

development 


10-year comprehensive strategic alliance 

to discover and develop therapeutic 

antibodies against a wide range of 

diseases, using MorphoSys’ HuCAL-based 

drug discovery platform. The two 

companies will combine their R&D 

capabilities to establish a pipeline of 

biopharmaceuticals and will share rights to 

co-developed products in specific 

territories.



Collaboration 


ProMetic Biosciences 2006 Vaccines Agreement to develop synthetic-ligand 

affinity adsorbent for the purification of a 

recombinant protein vaccine. ProMetic will 

receive funding from Novartis. Financial 

details were not disclosed. 

Entelos 2006 Drug development Research in multiple disease areas. 

Novartis will provide R&D funding, while 

Entelos will conduct biosimulation 

research, which predicts the effects of 

drugs using “virtual patients”. The 

technology will provide more information 

for Novartis’ drug development, including 

the design of phase III clinical trial design. 

Financial terms were not disclosed. 

Momenta 2006 Biosimilars Agreement between Sandoz and Momenta 

to develop four follow-on and complex 

generic versions of previously approved 

recombinant biotechnology and complex 

drugs. Sandoz will make an initial 

payment of $75m for the purchase of 

approximately 4.7m shares of Momenta, 

which is also eligible to receive up to 

$188m in additional payments if all 

milestones are achieved. 

Cytopia 2006 Drug discovery Global license and R&D collaboration to 

develop orally active, small molecules 

therapeutics targeting JAK3 kinases for 

the prevention of transplant rejection and 

the treatment of multiple indications in 

autoimmune diseases such as rheumatoid 

arthritis. Novartis will assume 

responsibility for product development and 

commercialization. Cytopia has retained 

co-promotion rights for Australia and New 

Zealand. 

Genelabs 2006 Drug discovery Agreement for the development and 

commercialization of compounds from 

Genelabs’ HCV non-nucleoside drug 

discovery program. Genelabs will receive 

$20m over a planned two-year research 

program. Additional payments could 

exceed $175m. In 2008, Genelabs 

reported that the partnership was 

continuing to the next phase. 




Collaboration 


SGX (now Eli Lilly) 2006 Drug discovery Agreement to develop and commercialize 

BCR-ABL inhibitors for the treatment of 

drug-resistant chronic myelogenous 

leukemia. SGX was acquired by Eli Lilly in 

August 2008. 

Infinity 2006 Drug discovery Exclusive access to a range of 

small-molecule inhibitors of the Bcl-2 

protein family that Infinity has identified 

using its DOS (Discovery Oriented 

Synthesis) chemistry technology. Novartis 

will pay $30m over the first two years of 

the deal. 

Merlion 2006 Drug discovery Merlion is to screen its library of natural 

compounds against a dengue fever target 

identified by Novartis. As part of the deal, 

Novartis may license drug candidates from 

Merlion and also has the option to develop 

and commercialize compounds in other 

therapeutic areas, in return for fees and 

milestones. 

Ablynx 2005 Therapeutic 

Nanobodies 

Alnylam 2005 Development of RNAi 

as therapeutic 


Agreement to discover and develop 

therapeutic Nanobodies against a number 

of targets in a range of disease areas. 

Ablynx will receive upfront fees and 

funding for R&D, and it will be eligible for 

milestone payments and royalties upon 

commercialization. Agreement extended 

for an additional year in December 2007. 

Ablynx announced in February 2008 that it 

has received an undisclosed milestone 

payment from Novartis. 

Alliance to apply Anlylam’s expertise in 

RNAi on unspecified major multiple 

diseases areas in Novartis’ research 

portfolio. Novartis will pay Alnylam 

$56.8m to cover up front payment and 

the purchase of around 4.2 million 

Alnylam shares (a 19.9% stake in the 

firm). Alnylam will also receive research 

and early development funding, milestone 

payments and royalties. In July 2008, it 

was reported that the alliance had been 

extended for an additional year, until 

October 2009.



Collaboration 


Immusol 2005 Target identification Three-year discovery, development and 

commercialization agreement to use 

Immusol’s gene-activation technology to 

discover targets, which Novartis might 

elect to use for the development of 

pharmaceuticals. 

Avalon 2005 Drug discovery Agreement to develop small-molecule 

drug using Avalon’s drug-discovery engine 

and product candidates in Novartis’ 

chemical library. Milestone achieved in 

January 2008. 

Immusol 2005 Drug discovery Three-year discovery, development and 

commercialization collaboration. Immusol 

will leverage its gene activation technology 

to discover biologically validated drug 

targets for Novartis. 

Idera (formerly Hybridon) 2005 Drug discovery Research collaboration and license deal for 

the discovery, optimization, development 

and commercialization of Toll-like receptor 

9 drug candidates targeting asthma and 

allergy based on Hybridon’s proprietary 

immune modulatory oligonucleotide (IMO) 

technology platform. 

Galapagos 2005 Design research 

programs 

Agreement to use Galapagos’ genomics 

services division’s SilenceSelect target 

discovery system. 

Conor Medsystems 2005 Drug-coated stents Conor will test three Novartis products 

(Glivec, Elidel and midostaurin) for use 

with future stents for the treatment of 

clogged heart arteries. If one of the 

compounds proves successful, Conor has 

the option to obtain a worldwide, 

non-exclusive license to commercialize 

products combining the compound and its 

stents. 




Collaboration 


Compugen 2005 Systems biology Pilot research project in the field of 

systems biology. Compugen will generate 

information about biological interaction 

network through the development of a 

proprietary platform for research and 

analysis of microarray and other biological 

data. Novartis will obtain sole rights to the 

specific results of the project, and 

Compugen will retain all rights to the 

research and discovery systems developed 

through the collaboration. 

ESBATech 2005 Drug discovery Collaboration on the discovery of receptor 

tyrosine kinase inhibitors using 

ESBATech’s cellular HTS technology for 

inhibitor identification. ESBATech will 

receive up-front and milestone payments 

and research funding. 

Biotech (Thailand’s 

National Center for 

Genetic Engineering and 

Biotechnology) 

2005 Natural products Agreement with the Thai government to 

develop new medicines based on natural 

herbs found in Thailand. Biotech will 

receive technology transfer and financial 

contributions. 

Avanir 2005 Inflammation drugs Global research, development and 

commercialization agreement to develop 

orally active small molecules therapeutics 

targeting macrophage migration inhibitory 

factor (MIF) as potential treatments for 

inflammatory diseases. Avanir will receive 

over $200m in combined upfront and 

milestone payments, plus royalties and 

funding of up to $2.5m per year for up to 

four years. 

Infinity 2005 Chemical drug 

development 


Two-year collaborative agreement for 

development of small molecules for the 

potential treatment of undisclosed 

indications. The molecules are to be 

designed by both companies, and 

synthesized using Infinity’s 

diversity-oriented synthesis technology.



Collaboration 


Triad 2004 Protein kinase Acquired rights to this program from Triad 

for the development of drugs to treat 

inflammatory disease. Triad may get up to 

$66 m in development and regulatory 

milestone payments and sales-based 

royalties on products. 

Syngene (Biocon, India) 2004 Chemistry Contract research agreement in areas of 

synthetic chemistry, molecular biology and 

custom synthesis. 

Cellzome 2004 Drug discovery Equity investment and 2 years research 

funding with 2-yr extension option 

developing protein targets in various 

diseases. Both companies retain 

development options of leads for 

license/milestone/ royalty fees. Agreement 

extended three times, until June 2008. 

Harvard University, the 

Massachusetts Institute of 

Technology, the Broad 

Institute 

2004 Diabetes research Novartis spending $4m in public/private 

collaboration to fund diabetes research to 

uncover genetic basis for type II diabetes. 

Xenon Pharmaceuticals 2004 Drug discovery 

(metabolic disorders) 

ParAllele BioScience 2004 Drug discovery 

(coronary artery 

disease) 


$157m 2-yr deal to develop 

anti-obesity/metabolic drugs focusing on 

Xenon’s SCD1 project with small 

molecules in preclinical trials. Xenon 

retains rights in some markets while 

Novartis to make equity investment and 

pay royalties. 

ParAllele’s Mismatch Repair Detection 

technology to identify new SNPs (single 

nucleotide polymorphisms) in (Novartis 

selected) genes to be profiled against 

coronary artery disease patients to identify 

associations. Novartis to use in drug 

discovery while ParAllele to retain 

diagnostic rights.



Collaboration 


MorphoSys 2004 Drug discovery 3-yr, $40m agreement (as well as 

potential milestones/royalties) to use the 

German company’s HuCal Gold antibody 

technology with MorphoSys providing 

antibodies to range of Novartis targets 

Novartis has option to take technology 

in-house for additional payment and 

option to extend to 5 yrs. Novartis made a 

milestone payment in August 2005. 

Collaboration extended until 2011. 

Myogen 2003 Cardiovascular 

research 

Novartis Institutes for Biomedical 

Research and Myogen collaborating on 

discovery of cardiovascular candidates 

that Novartis will gain exclusive rights to 

license in return for 3-yrs of funding. In 

2005, the collaboration was expanded to 

include Myogen’s histone deacetylase 

inhibitor (HDACi) program. Collaboration 

extended for two years in 2006. 

Vernalis 2003 Oncology Collaboration to investigate inhibitors of a 

Hsp90 implicated in the progression of a 

range of cancers. Extended for 3 years in 

2004 with STG5m equity investment (7m 

shares/4.6% stake) and $1.5m signing 

fee. Novartis to fund all R&D. 

Cytos 2003 Immunodrugs 2-yr licensing agreement of immunodrugs 

in field of Alzheimer’s disease triggering 

payment, license fees and milestones to 

Cytos. Already working on RA as part of 

2001 agreement but alliance in allergies 

discontinued and also working on 

therapeutic vaccines in CNS disorders. 



Mergers & Acquisitions 

• Year: 2008 

Major Events 

De cem ber: Novartis ac quired the pul mo nary drug de liv ery unit of Nektar (USA). It has ac quired spe cific 

pul mo nary de liv ery as sets, tech nol ogy, and in tel lec tual prop erty from Nektar for $115 mil lion in cash. 

Cer tain dry pow der and liq uid pul mo nary for mu la tion and man u fac tur ing as sets (in clud ing cap i tal equip - 

ment and man u fac tur ing cap i tal lease ob li ga tions) will be ac quired by Novartis. Novartis will also take on 

140 Nektar per son nel, as well as cer tain in tel lec tual prop erty and man u fac tur ing meth ods. Man u fac tur - 

ing and roy alty rights to tobramycin inhaled powder (Inhaled Tobi) will be transferred to Novartis. 

July: Novartis took a 25% stake in the US oph thal mol ogy com pany Alcon, which is ma jor ity-owned by 

Nes tle (Swit zer land), for $10.4 bil lion. Novartis also gained rights to ac quire the re main ing 52% Alcon 

stake held by Nes tle be tween Jan u ary 2010 and Jul 2011 for up to ap prox i mately $28 billion. 

Novartis be came the ma jor ity owner of Speedel Hold ings Ltd (Swit zer land), fol low ing the ac qui si tion of 

an ad di tional 51.7% stake. A man da tory pub lic ten der of fer be gan in Au gust 2008 to buy the re main ing 

shares in the com pany. Novartis states that to tal ac qui si tion costs are es ti mated at around $880 mil lion. 

Novartis has a long-stand ing col lab o ra tion with Speedel and states that Speedel’s R&D pipe line is a 

strong fit with its lead ing position in cardiovascular disease. 

June: Novartis signed a de fin i tive agree ment to ac quire Protez Pharmaceuticals (USA), along with the 

rights in North Amer ica and Eu rope to PZ 601, a novel hos pi tal an ti bi otic in clin i cal development. 

Jan u ary: It was re ported that Novartis is to close its Tsukuba re search cen ter in Ja pan. 

• Year: 2006 

Novartis ac quired the an i mal health busi ness of Sankyo Lifetech, a sub sid iary of Sankyo, ex pand ing the 

pres ence of Novartis An i mal Health busi ness in Japan. 

Novartis made a $569 mil lion of fer for NeuTec Pharma, a Brit ish de vel oper of anti-in fec tion drugs. With 

this move, Novartis in tends to ex pand its in fec tious dis ease port fo lio and strengthen its po si tion in hos pi - 

tal infections. 

Ac qui si tion of Chiron was com pleted af ter Novartis had raised its of fer for a third time to please some 

Chiron’s share hold ers who threat ened to vote against the deal. The fi nal price was $48 per share. 

• Year: 2005 

Novartis an nounced that it had en tered into a de fin i tive merger agree ment with Chiron. It will ac quire all 

of the re main ing shares of Chiron that it does not al ready own for $45 per share. 

Novartis bought a 19.9% stake in Alnylam, a US leader in RNA in ter fer ence (RNAi) re search, for $56.8 

mil lion. The pay ment, un der pin ning a broader col lab o ra tion be tween the two com pa nies, is part of a 

com plex deal which could see RNAi tech nol ogy even tu ally in cor po rated into Novartis’ own 

pharmaceuticals R&D. 



Novartis ac quired Bris tol-Myers Squibb’s US and Ca na dian OTC and con sumer prod ucts busi ness for 

$660 mil lion in cash. 

Novartis ac quired the pri vate Ger man ge neric phar ma ceu ti cal com pany Hexal from its own ers, Thomas 

and Andreas Struengmann. Novartis also took a 67.7% stake (65.4% fully di luted) in the fast-grow ing 

US generics com pany Eon Labs, in which the broth ers had an in di rect ma jor ity hold ing. The to tal cost of 

this ac qui si tion was Euro5.65 million. 

• Year: 2004 

Sandoz ac quired AstraZeneca’s generics unit Durascan in Den mark for an un dis closed sum. This gave 

Sandoz an op er a tion base for the Nordic mar ket and a solid po si tion in the Dan ish generics market. 

Sandoz ac quired Sabex Hold ings, Can ada’s larg est in ject able generics com pany, in a $565 mil lion cash 

trans ac tion (six times the com pany’s rev e nue), of fer ing Sandoz ac cess to Sabex’s ster ile man u fac tur ing 

spe cialty ex per tise (com plete with dif fi cult to gain FDA man u fac tur ing sta tus), as well as en try into the 

Canadian generics sector. 

Hexal ac quired the pro duc tion fa cil ity of esparma (Ger many) in Osterweddingen as its sales and mar ket - 

ing busi ness was bought by Wockhardt (In dia). 

Hexal ac quired an FDA-cer ti fied chem i cals syn the sis fa cil ity in Radebeul/Dresden from Degussa (Ger - 

many) for an un dis closed price. 

• Year: 2003 

Novartis’ Med i cal Nu tri tion Prod ucts di vi sion ac quired the Adult Nu tri tional busi ness of Mead John son & 

Com pany (a sub sid iary of Bris tol-Myers Squibb) for $385 million. 

Novartis paid $255m for 50% own er ship of pri vately owned Idenix (USA), gain ing ac cess to its late stage 

an ti vi ral in R&D for hep a ti tis B (telbivudine) and an oral ther apy for hep a ti tis C. 

It was re ported that Novartis had boosted its stake in Roche to 32.7%. But the fam ily shareholding pool 

that con trols Roche has sig naled that it is still not in ter ested in a merger. 

• Year: 2002 

Novartis ac quired ge neric man u fac turer, Lek (Slovenia) for Euro860 mil lion. 

• Year: 2001 

Ac quired a 20% vot ing stake in Roche (Swit zer land) from Swiss in ves tor Mar tin Ebner’s BZ Group, fuel - 

ling spec u la tion of a merger. 

Novartis Generics ac quired Lagap Pharmaceuticals (UK) from Adcock Ingram (South Af rica). 

Novartis and BioTransplant’s (USA) joint ven ture Im merge BioTherapeutics for the de vel op ment of 

xenotransplantation was in au gu rated. Novartis owns 67% and BioTransplant 33%. 

Hexal’s sub sid iary in Ar gen tina, Boxalpharma, merged with Lanpharm to form Hexal Ar gen tina. 

Hexal’s unit in Tur key, Ilsan Iltas, ac quired Koz Pharmaceuticals/Biokem. 



• Year: 2000 

Novartis Generics ac quired Labinca (Ar gen tina). Labinca spe cial izes in on col ogy, rheumatology, car dio - 

vas cu lar and gas tro in tes ti nal diseases. 

Novartis spun-off its Ag ri busi ness sec tor to its share hold ers as part of the trans ac tions nec es sary to form 

Syngenta AG. On the same day AstraZeneca (UK) spun-off its Crop Pro tec tion ac tiv i ties which then 

merged with Novartis’ Ag ri busi ness to form Syngenta AG. 

CIBA Vi sion com pleted its ac qui si tion of Wes ley Jessen VisionCare. 

Novartis Nu tri tion ac quired Heilpunkt Naturpharma (Ger many) from Lichtwer Pharma. 

Ac quired Grandis Biotech (Ger many). 

Hexal ac quired 100% of the US generics com pany Eon Labs Man u fac tur ing, based in New York. 

• Year: 1999 

Geneva Pharmaceuticals ac quired the as sets of Invamed Inc (USA) for SFr149 mil lion. 

Novartis An i mal Health ac quired Vericore Hold ings Ltd (UK), a com pany fo cused on vac cines, para siti - 

cides and other prod ucts for farm an i mals, pharmaceuticals for com pan ion an i mals, and aquaculture. 

CIBA Vi sion an nounced that it had signed a deal to ac quire the intraocular lens busi ness of Men tor Corp 

(USA). 

Hexal ac quired Ilsan Iltas (Tur key) and es tab lished it as its sub sid iary in Tur key. Hexal also ac quired 

Milen, one of the lead ing ac tive phar ma ceu ti cal in gre di ent man u fac tur ers in Turkey. 

• Year: 1997 

Novartis an nounced that a sec ond pro posal made to ac quire all out stand ing shares (28.8%) of SyStemix 

(USA) had been de clined. SyStemix’s in de pend ent di rec tors de clined an orig i nal of fer in 1996. 

• Year: 1996 

The US FTC granted pro vi sional ap proval to the merger of Ciba and Sandoz to form Novartis. FTC ap - 

proval was needed be cause Ciba and Sandoz had busi ness ar eas which over lapped in North Amer ica: 

corn her bi cides, flea and tick con trol and gene ther apy. Sandoz’s corn her bi cide and an i mal health busi - 

ness and the flea and tick busi ness had to be sold. In the area of gene ther apy, Novartis agreed to pro vide 

ac cess to her pes sim plex vi rus thymidine kinase tech nol ogy, ex vivo gene ther apy, Fac tor VIII for he mo - 

philia gene ther apy, and cytokines for use in cell ex pan sion for ex-vivo gene ther apy. Through the agree - 

ment, the FTC aimed to es tab lish Rhone-Poulenc Rorer (now sanofi-aventis, France) as a vi a ble 

com pet i tor to Novartis in the gene ther apy field. Novartis also agreed to pro vide cross-li censes of cer tain 

Novartis gene therapy technologies to Chiron (USA). 

Sandoz ac quired Ger man generics com pany, Azupharma, from Gehe (Ger many). 

Sandoz ac quired Laboratoire Sodietal (France), an enteral clin i cal nu tri tion firm. 

Sandoz Nu tri tion in creased its stake in Gazzoni (It aly) to 67%. It had held a ma jor ity stake in Gazzoni 

since 1993. 



Sandoz an nounced it was to buy Imutran (UK), a biotech firm spe cial iz ing in xenotransplantation. 

• Year: 1995 

Sandoz ac quired Ge netic Ther apy Inc (USA) for $295 mil lion. It al ready owned 6% of Ge netic Ther apy. 

• Year: 1994 

Sandoz ac quired baby food com pany, Gerber (USA) for $3.7 bil lion. 

Sandoz agreed to pur chase Monal (France), a maker of plant-based drug prod ucts and herbal teas. 

Ciba in creased its 7.9% stake in Chiron to 49.9% for SFr2,806 mil lion. 

Ciba ac quired Rhone-Poulenc Rorer’s (now sanofi-aventis) North Amer i can OTC busi ness; J&J’s (USA) 

Iolab Corp’s ophthalmics busi ness; Lab o ra to ries Henri Faure (France), an ophthalmological pro ducer; 

and a $5 mil lion stake in CoCensys (USA) as part of a de vel op ment and mar ket ing deal. 

• Year: 1993 

Sandoz bought the Reforma Group (Neth er lands), which spe cial izes in adult di etetic prod ucts. 

• Year: 1992 

Ciba ac quired the ma jor ity of Un ion Med i cal (Ja pan), an eyecare prod uct dis trib u tor; Carreras SA (Spain), 

a dermatologicals man u fac turer; Tri ton Di ag nos tics Inc’s (USA) can cer di ag nos tics busi ness; Fisons’ 

(UK) North Amer i can OTC busi ness; and bought the re main ing shares in Ricky Contact Lenses (Japan). 

• Year: 1991 

Sandoz’s Nu tri tion di vi sion pur chased the di etary prod ucts com pany Dietetique et Sante (France) from 

Rhone-Poulenc Rorer; and an 82% hold ing in Eden (Ger many), a Ger man healthfoods company. 

Ciba ac quired a mi nor ity stake in InSite Vi sion Inc (USA). The deal also cov ered R&D of oph thal mic 

pharmaceuticals and sub se quent li cens ing; Laboratoire Mar ti net Ophthalmologie (France); and a stake 

in Litpharm (CIS), a phar ma ceu ti cal pro duc tion and dis tri bu tion company. 

• Year: 1990 

Ciba bought ICI’s (UK) OTC busi ness in the UK and Ire land; Bris tol-Myers Squibb’s (USA) an i mal health 

busi ness; Webber Inc (Can ada), an OTC prod ucts man u fac turer; and a mi nor ity stake in Tanox 

Biosystems (USA) as part of a re search deal with Tanox. 

• Year: 1980s 

1989: Sandoz ac quired Virgo Op tics (USA). Ciba pur chased Corn ing Glass Works’ (USA) 50% stake in the 

Ciba-Geigy Corn ing Di ag nos tics jv set up in 1985. Ciba ac quired To ledo and Ohaus. 

1987: Sandoz Nu tri tion ac quired Dietcentrum SA (Bel gium), a healthfood man u fac turer in creased its 

hold ing in the Ce real Group (France) to a ma jor ity stake. It also made three small ac qui si tions, in clud ing 

the Ideal brand, to add to the Wasa Group. 



1986: Sandoz took a 50% stake in Gema/Liessa SA (Spain), an an ti bi ot ics raw ma te rial pro ducer, to form 

a joint ven ture with Lonza (Swit zer land). Sandoz bought a ma jor ity stake in LPB Istituto Farmaceutico 

(It aly). Sandoz con sol i dated its US OTC busi ness, merg ing Dorsey Labs with Ex-Lax Phar ma ceu ti cal Co. 

Ciba ac quired Nes tle’s (Swit zer land) Eu ro pean and US con tact lens busi nesses. Ciba pur chased 50% of 

Dispersa AG (Swit zer land) and Dispersa-Baeschlin GmbH (Ger many), phar ma ceu ti cal pro duc ers, from 

Galenica (Switzerland). 

1985: Ciba ac quired Amer i can Op ti cal Corp’s (USA) con tact lens and lenscare busi ness. 

1983: Sandoz ac quired sweet en ers firm, F Ahlgrens Tekniska Fabrik (Swe den). Ciba ac quired Titmus 

Eurocon (Ger many), a con tact lens and lenscare prod ucts man u fac turer. 

1982: Sandoz bought Wasa (Swe den), a pro ducer of crispbread. 

1981: Sandoz ac quired the OTC med i cines unit of Culbro Corp and Ex-Lax Phar ma ceu ti cal Co Inc (USA); 

and Vi king Brews Ltd, North Shields, UK. 

1980: Ciba ac quired the Mett ler com pany. 

• Year: 1970s 

1979: Ciba bought SJ Tutag & Co (USA), a generics man u fac turer, re nam ing it Geneva Pharmaceuticals 

Inc. 

1978: Sandoz ac quired Leofarin Group (Swit zer land). 

1976: Sandoz pur chased 99% of Northrup, King & Co (USA) and bought Chi cago Di etet ics Co (USA). 

1972: Sandoz bought Delmark (USA), a nu tri tional firm and STIA (Swit zer land). 

1970: Ciba, founded in 1884, and JR Geigy Co, founded in 1758, merged to form Ciba-Geigy Lim ited. 

• Year: 1960s 

1967: Sandoz ac quired Wan der (Swit zer land), a nu tri tional prod ucts firm. 

1963: Sandoz bought Biochemie GmbH (Aus tria), an an ti bi otic man u fac turer. 

Other Major Events 

• Year: 2009 

Feb ru ary: Novartis launched a ma jor bond mar ket trans ac tion, is su ing a two-tranche bond with a to tal 

size of $5 bil lion that has been reg is tered in the US. The trans ac tion con sists of the fol low ing tranch es: $2 

bil lion of a 5-year bond with a cou pon of 4.125% and $3 bil lion of a 10-year bond with a coupon of 

5.125%. 

• Year: 2008 

Oc to ber: Novartis an nounced plans to buy the pul mo nary drug de liv ery unit of Nektar (USA). It will ac - 

quire spe cific pul mo nary de liv ery as sets, tech nol ogy, and in tel lec tual prop erty from Nektar for $115 mil - 

lion in cash. Cer tain dry pow der and liq uid pul mo nary for mu la tion and man u fac tur ing as sets (in clud ing 

cap i tal equip ment and man u fac tur ing cap i tal lease ob li ga tions) will be ac quired by Novartis. Novartis will 



also take on 140 Nektar per son nel, as well as cer tain in tel lec tual prop erty and man u fac tur ing meth ods. 

Man u fac tur ing and roy alty rights to tobramycin inhaled powder (Inhaled Tobi) will be transferred to 

Novartis. 

July: It was re ported that Novartis has signed a deal with the Swiss firm Lonza to help it de velop and 

man u fac ture new bi o log i cal prod ucts. 

June: Sandoz of fi cially opened its global HQ build ing in Holzkirchen, Ger many, fol low ing in vest ment of 

Euro35 mil lion ($55 bil lion). 

May: Amedipharm (UK) ac quired rights to a num ber of older Novartis prod ucts out side the USA. These 

are: Apresoline, Hygroton, Hygroton Re ser pine, Cafergot, Deseril, Dihydergot, Migranal, Tofranil, 

Ludiomil, Locacorten, Locasalen and Sicorten. 

April: Novartis ap pointed Lud wig Hantson as head of its US phar ma ceu ti cal busi ness. 

• Year: 2007 

Novartis launched the “For ward” ini tia tive to im prove com pet i tive ness. This ini tia tive will sim plify or ga ni - 

za tional struc tures, ac cel er ate and de cen tral ize de ci sion-mak ing pro cesses, re de sign the way Novartis 

op er ates and pro vide pro duc tiv ity gains. Pre-tax an nual cost sav ings of $1.6 bil lion are ex pected in 2010. 

Ap prox i mately 2,500 full-time po si tions are ex pected to be re duced from among the cur rently nearly 

100,000 full-time employees within the group. 

Novartis an nounced the con struc tion of a $700 mil lion biotech man u fac tur ing fa cil ity in Sin ga pore. The 

plant will con tain Novartis’ larg est bioreactor world wide. Once open, the new fa cil ity will em ploy 300 peo - 

ple. Con struc tion will start in 2008 and com ple tion is expected in 2012. 

Novartis sold its Gerber baby food busi ness for $5.5 bil lion in cash to Nes tle (Swit zer land). 

• Year: 2006 

Novartis an nounced the di vest ment of its med i cal nu tri tion busi ness to Nes tle for $2.5 bil lion. 

Novartis an nounced plans to in vest $100 mil lion in a new drug dis cov ery fa cil ity in Shang hai. 

Novartis an nounced plans to build the first cell cul ture-de rived in flu enza vac cines man u fac tur ing plant in 

the US at a site in Holly Springs, North Carolina. 

Novartis was one of a hand ful of com pa nies awarded mul ti mil lion dol lar con tracts by the US gov ern ment 

to work on cell-based pro duc tion tech nol o gies as part of the gov ern ment’s avian-flu pan demic plan. 

Novartis will use the $221 mil lion con tract to fund the con struc tion of a new cell-based plant in the US that 

will sup ply the American market only. 

Novartis set up a global R&D cen ter for OTC prod ucts in Thane, near Mumbai, In dia. The new fa cil ity will 

de velop OTC prod ucts, par tic u larly in ar eas such as cough/cold, al ler gies, smok ing ces sa tion, gas tro in - 

tes ti nal dis or ders, der mal in fec tions and nutritional supplements. 

Novartis sold its Span ish generics unit, Uso Racional, to Pliva (Croatia) for Euro21.5 mil lion ($25.6 mil - 

lion). 



• Year: 2005 

Novartis li censed-in rights to de velop Takeda's Prevacid (lansoprazole) as an OTC prod uct in the USA and 

its ter ri to ries. 

Novartis agreed to sell its Nu tri tion et Sante unit to ABN AMRO Cap i tal France for $260 mil lion. 

Novartis an nounced plans to move the HQ of its Sandoz unit to south ern Ger many from Aus tria as part of 

an in te gra tion pro cess. The new HQ will be in Holzkirchen, Ba varia. 

It was re ported that Novartis In dia is to trans fer its anti-TB rifampicin bulk drug busi ness, along with its 

fa cil ity in Mahad (In dia) to the Sandoz generics unit of Novartis. In re turn, Novartis will pay the in de pend - 

ently-owned Novartis In dia Rs307.7 million. 

Novartis an nounced plans to in vest $4 mil lion in mod ern iz ing its two generics plants in Ar gen tina with the 

aim of ex port ing to Eu rope. The main plant to be mod ern ized spe cial izes in on col ogy prod ucts, un der the 

Sandoz name. 

Ten com pa nies, in clud ing Novartis, be gan en roll ment on the To gether Rx Ac cess Card Pro gram, de signed 

to aid un in sured Amer i cans gain better ac cess to pre scrip tion prod ucts. The par tic i pat ing com pa nies of fer 

sav ings on more than 275 brand-name pre scrip tion drugs for those who meet in come and age eligibility 

requirements. 

• Year: 2004 

Novartis an nounced plans to re struc ture its Sandoz unit to cut costs and im prove in te gra tion with the 

par ent com pany. 

Novartis an nounced plans to in vest around $180 mil lion in new bulk pro duc tion fa cil ity in Sin ga pore. 

Lek opened a new Euro18 mil lion plant for biopharmaceuticals, Port1, in Menges, near the cap i tal 

Ljubljana. Si mul ta neously, Sandoz opened a Euro50 mil lion plant for biopharmaceuticals in Aus tria and 

the two fa cil i ties to gether will cre ate over 100 jobs and strengthen Sandoz’ franchise. 

• Year: 2003 

Novartis opened $122 mil lion In sti tute for Trop i cal Dis eases in Sin ga pore. 

• Year: 2002 

Novartis sold its food and bev er age busi ness to As so ci ated Brit ish Foods for Euro272.5 mil lion. 

Novartis es tab lished the $250 mil lion Novartis In sti tute for Bio med i cal Re search, Inc. (NIBRI) in Cam - 

bridge, Mas sa chu setts. NIBRI will be the new global R&D head quar ters of Novartis. 

• Year: 2001 

Novartis’ sub sid iary Biochemie opened the An ti bi otic Re search In sti tute (ABRI) in Vi enna. 

• Year: 2000 

Novartis un veiled a re struc tur ing and re or ga ni za tion of its phar ma ceu ti cal di vi sion. It was split into three 

in de pend ent units: A Pri mary Care group; a Spe cialty busi ness; and a third in de pend ent busi ness unit 

was also cre ated which con cen trates on the mar ket ing of slow-grow ing mature products. 



Novartis be gan trad ing on the New York Stock Ex change. 

• Year: 1999 

Eu ro pean reg u la tory au thor i ties granted Barilla (It aly) per mis sion to ac quire Novartis’ Wasa crisp breads 

sub sid iary for SFr475 million. 

Novartis an nounced plans to make Novartis Sci en tific Ser vices an in de pend ent com pany. The unit of fers 

sci en tific and tech ni cal ser vices to the phar ma ceu ti cal and chem i cal industries. 

Novartis sold its 51% in ter est in OLW Snacks (Swe den), its 49% in ter est in Chips OLS (Swe den), its 

100% stake in the Eden Group (Ger many), and its 100% in ter est in Wasa op er a tions in Swe den, Ger - 

many, Den mark, Nor way and Po land. The sale price for these divestments (all part of Con sumer Health) 

to taled SFr625 million. 

• Year: 1998 

The Generics sec tor ac quired the an ti bi ot ics and the Frank furt fer men ta tion plant of Hoechst Marion 

Roussel (now sanofi-aventis, France). 

Agreed to sell sev eral Ital ian sugar-free con fec tion ery brands to Compagnie Industriali Riunite SpA (It - 

aly). 

Novartis was one of a num ber of ma jor phar ma ceu ti cal com pa nies to fund the Cen ter for Bio med i cal Ac - 

cel er ated Mass Spec trom e try near York, Eng land, opened late in 1998. 

The Novartis Re search Foun da tion an nounced the cre ation of the Novartis In sti tute for Func tional 

Genomics, a re search cen ter de voted en tirely to func tional genomics, the study of the re la tion ships be - 

tween par tic u lar ge no types and dis ease states, in La Jolla, California. 

Novartis an nounced plans to close or sell 35 of its 62 plants world wide, with a loss of over 1,000 jobs. 

Most of the di vest ing was in Asia and the USA as Novartis con cen trates its ac tiv i ties in Eu rope, but five of 

14 Eu ro pean plants were also closed. All chem i cal pro duc tion was halted in the USA and Asia. 

• Year: 1997 

Novartis an nounced plans to con sol i date its op er a tions in South Ko rea via the sep a ra tion and in te gra tion 

of Ciba’s stake in the ex ist ing Searle Ciba-Geigy jv. Searle Ciba-Geigy, in which the two com pa nies had 

stakes of 45% and lo cal part ners hold 10%, was dis solved and split into two sep a rate en ti ties. Ciba’s op - 

er a tions, prod ucts and staff were trans ferred to Novartis. Sandoz’ ex ist ing op er a tions in the coun try were 

merged with those of Ciba to form a wholly-owned subsidiary. 

Thermo Ecotek Corp (USA) ac quired Novartis’ Ba cil lus thuringiensis-biopesticide prod uct lines for $19.1 

mil lion. 

Novartis es tab lished a Foun da tion for Ge ron to log i cal Re search. 

Walden (USA), a pri vate eq uity fund, took a stake in the Ciba CKD Biochem joint ven ture. Af ter the place - 

ment Novartis, Hindustan Ciba-Geigy (In dia) and Chong Kun Dang (South Ko rea) held a 51% stake be - 

tween them. 

• Year: 1995 

Ciba an nounced plans for an an ti bi ot ics man u fac tur ing jv with CKD (South Ko rea), tak ing a 51% stake. 



• Year: 1994 

Ciba es tab lished a deal with Cititech, In sti tu tion of Mi cro bi ol ogy and Ep i de mi ol ogy, and Kunming Phar - 

ma ceu ti cal Fac tory (all China) to co-de velop Coartem (lumefantrine + artemether) for malaria. 

• Year: 1993 

The Beijing Ciba-Geigy Pharma jv set up a $20 mil lion CNS drug man u fac tur ing plant in China. 

• Year: 1987 

Sandoz sold a 50% stake in hos pi tal sup ply group, Sopamed (Swit zer land), to Gambro (Swe den), which 

also bought Rhone-Poulenc’s 50%. 

Ciba set up a jv with Beijing Gen eral Phar ma ceu ti cal Corp (China) to build a fac tory near Beijing. 

• Year: 1986 

Hexal Chemie GmbH & Co KG was founded by the broth ers Andreas and Thomas Struengmann. 

• Year: 1893 

Sandoz was re named Sandoz & Co on death of Al fred Kern. 

• Year: 1886 

Sandoz was es tab lished by Edouard Sandoz and Al fred Kern un der the name of Kern and Sandoz. 


IMS COM PANY PRO FILES NOVARTIS SUBSIDIARY LISTING 

Novartis Subsidiary Listing 

The fol low ing is a list of the main phar ma ceu ti cal sub sid iar ies and rep re sen ta tive of fices of the Novartis 

group. The in for ma tion is taken from the IMSWorld pub li ca tion IMS Com pany Search. Sub sid iary de - 

tails are ob tained us ing a va ri ety of in for ma tion sources, in clud ing send ing ques tion naires di rectly to the 

com pany in each coun try, as well as in for ma tion pro vided by the com pa nies which are pro filed. The prod - 

uct, ther a peu tic range and sales in for ma tion is taken from the IMS MI DAS database. 

ALGERIA 

NOVARTIS 

Full Name: Novartis Pharma Ser vices AG, Bu - 

reau de Li ai son Algerie 

Street Ad dress: Bois des Cars 2, Lot No 215 Dely 

Ibrahim, Route de Cheraga, Alger 

Tel: +213 21 37 17 68 

Fax: +213 21 37 17 92 

Home Page: www.mea.novartis.com 

De scrip tion: Li ai son of fice. Di vi sions in clude: 

Novartis Con sumer Health. 

Phar ma ceu ti cal Sales: US$ 100-110 mil lion 

Prod ucts (% of Sales by Lead ing 5): 65-70% 

Ther a peu tic Classes (% of Sales by Lead ing 

5): 70-75% 

Dose Forms (% of Sales by Lead ing 5): 

95-100% 

Prin ci pal Prod ucts: 

TAREG (an gio ten sin-II an tag o nist plain) 

COTAREG (an gio ten sin-II an tag o nist com bi na - 

tion) 

LOXEN (cal cium an tag o nist plain) 

LESCOL (cho les terol/triglyceride reg u lat ing prep - 

a ra tion) 

FORADIL (B2-stim u lant) 

Ther a peu tic Range: 

renin-an gio ten sin sys tem agents 35% 

cal cium an tag o nists 15% 

antiasthma and COPD prod ucts 9% 

lipid-reg u lat ing/antiatheroma prep a ra tions 9% 

antiepileptics 6% 

Lead ing Dose Forms: 

coated tab lets 39% 

cap sules 39% 

tab lets 13% 

liq uids 4% 

in fu sions 3% 

SANDOZ 

Full Name: Gen er ale Pharmaceutique Ser vice, 

Sandoz Mar ket ing 

Street Ad dress: 119, Ter Rue Didouche Mourad, 

16006 Alger 

Tel: +213 21 51 57 01 

Fax: +213 21 51 35 09 




5): 85-90% 


90-95% 


TIRLOR (an ti his ta mine sys temic) 

OSPEN (pen i cil lin me dium/nar row spec trum) 

UROBACID (uri nary anti-in fec tive/an ti sep tic) 

OSPEXIN (cephalosporin) 

DOTUR (tet ra cy cline/com bi na tion) 


antibacterials sys temic 54% 

an ti his ta mines sys temic 13% 

urologicals 10% 


vi ta mins 5% 


tab lets 39% 


cap sules 15% 

vi als 13% 

liq uids 12% 

ARGENTINA 

HEXAL 

Full Name: HEXAL Ar gen tina S.A. 

Street Ad dress: Paseo Co lon 221, Piso 7, 1063 

Bue nos Ai res 

Tel: +54 11 4334-2080 

Fax: +54 11 4334-2084 

Email: info@hexal.com.ar 

Home Page: www.hexal.com.ar 

De scrip tion: Es tab lished 2001. 

Con tacts (Pharm): Chair man: Dr Erich Brun - 

ner; Gen eral Con tact: Soledad Pasman 



NOVARTIS 

Full Name: Novartis Ar gen tina S.A. 

Street Ad dress: Ramallo 1851, 1429 Bue nos Ai - 

res 

Tel: +54 11 4703-7000 

Fax: +54 11 4703-7188 

Home Page: www.ar.novartis.com 

De scrip tion: Es tab lished 1997. Di vi sions in - 

clude: Novartis OTC. 

Sub sid iary of: Novartis, Swit zer land (100%) 




5): 60-65% 


95-100% 


TEGRETOL (antiepileptic) 

DIOVAN (an gio ten sin-II an tag o nist plain) 

RELIVERAN (gastroprokinetic) 

TRILEPTAL (antiepileptic) 

DIOVAN-D (an gio ten sin-II an tag o nist com bi na - 

tion) 




func tional gas tro-in tes ti nal dis or der drugs 10% 

antithrombotic agents 6% 

anti rheu ma tics sys temic 5% 


tab lets 48% 


liq uids 12% 

cap sules 4% 

am poules 3% 

SANDOZ 

Full Name: Sandoz S.A. 

Street Ad dress: Av Cramer 4130, C1429AJZ 

Bue nos Ai res 

Tel: +54 11 4704-2401 

Fax: +54 11 4701-8754 

De scrip tion: De vel oper, man u fac turer, for mu la - 

tor, packager/as sem bler, im porter, ex porter, dis - 

trib u tor, pro moter, sales/detailer. Man u fac tures, 

ex ports, dis trib utes for other com pa nies. Prod uct 

ranges in clude: phar ma ceu ti cal prod ucts 

(branded, pre scrip tion, non-pre scrip tion), hos pi - 

tal pharmaceuticals. Es tab lished 1946. 300 

pharmaceutical employees in 2006. 

Rep re sen ta tives/De tail ers (Pharm, Num - 

ber): 51-100 (2006) 

Con tacts (Pharm): Chair man: Ignacio 

Ketelhohn; Com mer cial Op er a tions: Roberto 

Carlucci; Man u fac ture: Dan iel San Juan; Mar ket 

Re search: Ce cilia Bollero; Re search & De vel op - 

ment: Silvia Dominguez; Gen eral Con tact: Cecilia 

Bollero 





5): 50-55% 


95-100% 


LABISTATIN (cho les terol/triglyceride reg u lat ing 

prep a ra tion) 

TAMSUNA (BPH (be nign pros tatic hy per tro phy) 

prod uct) 

ALLOPURINOL-INCA (antigout prep a ra tion) 

VARTALON COMPLEMEN (musculoskeletal prod - 

uct other) 

SOLUTRAT (bile ther apy/cholagogue) 


lipid-reg u lat ing/antiatheroma prep a ra tions 

16% 

musculoskeletal drugs other 13% 


antigout prep a ra tions 8% 



tab lets 38% 


cap sules 20% 

pow ders/gran ules 11% 

liq uids 3% 

AUSTRALIA 

CIBA VI SION 

Full Name: CIBA Vi sion Aus tra lia Pty Ltd 

Postal Ad dress: Pri vate Bag 100, Baulk ham Hills 

Busi ness Cen tre, Baulk ham Hills, NSW 2153 

Street Ad dress: 1/42 Car ring ton Rd, Cas tle Hill, 

NSW 2154 

Tel: +61 2 9680 6655 

Fax: +61 2 9899 9430 

Home Page: www.cibavision.com.au 

De scrip tion: Man u fac turer, packager/as sem - 

bler, im porter, dis trib u tor, pro moter, 

sales/detailer. Prod uct ranges in clude: phar ma - 

ceu ti cal prod ucts (branded, pre scrip tion, 

non-pre scrip tion), oph thal mic prod ucts. Es tab - 



lished 1992. Di vi sions in clude: Contact Lenses; 

Lens Care. 

Con tacts (Pharm): Chair man: Dor o thy 

McDiarmid; Com mer cial Op er a tions: Brian Spiller, 

Ron Baroni; Man u fac ture: Da vid Mackay; Gen eral 

Con tact: Roueen Miller 


Prod ucts (% of Sales by Lead ing 5): 

95-100% 


5): n.a. 

Dose Forms (% of Sales by Lead ing 5): n.a. 


IN A WINK (ar ti fi cial tears/oc u lar lu bri cant) 

AQUIFY (con tact lens prep a ra tion) 

AOSEPT (con tact lens prep a ra tion) 

PAA (ar ti fi cial tears/oc u lar lu bri cant) 

HPMC PAA (ar ti fi cial tears/oc u lar lu bri cant) 


ophthalmologicals 100% 


liq uids 76% 

gels/sols 24% 

HEXAL 

Full Name: Hexal Aus tra lia Pty Ltd 

Street Ad dress: Level 4, Suite 1-6, 100 Har ris 

St, Pyr mont, NSW 2009 

Tel: +61 2 9566 1500 

Fax: +61 2 9566 1458 

Email: askhexal@hexal.com.au 

Home Page: www.hexal.com.au 

De scrip tion: Man u fac turer, im porter, dis trib u - 

tor, sales/detailer. Man u fac tures, dis trib utes, 

sells/de tails for other com pa nies. Prod uct ranges 

in clude: phar ma ceu ti cal prod ucts (pre scrip tion, 

non-pre scrip tion), hos pi tal pharmaceuticals. 

Established 1997. 

Con tacts (Pharm): Chair man: Clem ens Von 

Oswald; Com mer cial Op er a tions: Mike Hobbs; 

Gen eral Con tact: Mimi Louie 

NOVARTIS 

Full Name: Novartis Pharmaceuticals Aus tra lia 

Pty Ltd 

Postal Ad dress: PO Box 101, North Ryde, NSW 

1670 

Street Ad dress: 54 Waterloo Rd, North Ryde, 

NSW 2113 

Tel: +61 2 9805 3555 

Fax: +61 2 9805 1330 

Home Page: www.novartis.com.au 

De scrip tion: Re searcher, im porter, dis trib u tor, 

pro moter, sales/detailer. Prod uct ranges in clude: 

phar ma ceu ti cal prod ucts (branded, pre scrip tion), 

hos pi tal pharmaceuticals, oph thal mic prod ucts. 

Es tab lished 1997. 250 phar ma ceu ti cal em ploy ees 

in 2008. Di vi sions in clude: On col ogy; Trans plan - 

ta tion & Im mu nol ogy; Primary Care; 

Ophthalmics. 


ber): 51-100 (2008) 

Con tacts (Pharm): Chair man: Mar tin Cross; 

Com mer cial Op er a tions: Das Nair, Rob ert 

Huggan, Roger Suttie, Sa rah Boyce; Mar ket Re - 

search: Darren Griffiths, Marion Tan, Ga bri elle 

Wil son; Re search & De vel op ment: Dr Nicol 

Kurstjens; Gen eral Con tact: Sue Cavanagh 





5): 55-60% 


80-85% 


LUCENTIS (oc u lar antineovascularization prod - 

uct) 

GLIVEC (antineoplastic other) 

FAMVIR (an ti vi ral non-HIV) 

NEORAL (immunosuppressive agent) 

ZOMETA (bone cal cium reg u la tor) 



antineoplastics 15% 

immunosuppressive agents 8% 

antivirals sys temic 7% 




vi als 27% 

tab lets 15% 

cap sules 7% 

am poules 5% 

NOVARTIS CON SUMER HEALTH 

Full Name: Novartis Con sumer Health 

Australasia Pty Ltd 

Postal Ad dress: PO Box 4499, Mel bourne, Vic to - 

ria 3170 

Street Ad dress: 327 - 329 Po lice Road, Level 2, 

Mul grave, Mel bourne, Vic to ria 3170 

Tel: +61 3 9701 2711 

Fax: +61 3 9701 2911 



Home Page: www.novartis.com.au 


SANDOZ 

Full Name: Sandoz Aus tra lia Pty Ltd 

Street Ad dress: Level 4, Suite 7-19, 100 Har ris 

St., Pyr mont, NSW 2009 

Tel: +61 2 9566 1500 

Fax: +61 2 9566 1458 




ceu ti cal prod ucts (branded, pre scrip tion), bi o log i - 

cal prod ucts. Es tab lished 2005. 100 

phar ma ceu ti cal employees in 2007. 


ber): 51-100 (2007) 

Con tacts (Pharm): Chair man: John Stokes; 

Gen eral Con tact: Rene Llewellyn 





5): 60-65% 


95-100% 


SIMVAHEXAL (cho les terol/triglyceride reg u lat ing 


PROBITOR (antiulcerant) 

HEXAL METARAMINOL (car diac stim u lant 

non-glycoside) 

RAMIPRIL SANDOZ (ACE in hib i tor plain) 

MEPRAZOL (antiulcerant) 



18% 


ant ac ids/antiflatulents/antiulcerants 13% 

psychoanaleptics 11% 



tab lets 58% 

cap sules 17% 


vi als 7% 

am poules 6% 

AUSTRIA 

HEXAL 

Full Name: Hexal Pharma GmbH 

Street Ad dress: Carlbergergasse 44, A-1235 

Wien 

Tel: +43 1 866 59 9350 

Fax: +43 1 486 96 22-9344 

Email: of fice@hexal.at 

Home Page: www.hexal.at 

De scrip tion: Im porter, dis trib u tor, pro moter, 


ceu ti cal prod ucts (branded, unbranded, pre scrip - 

tion, non-pre scrip tion), hos pi tal pharmaceuticals, 

di ag nos tic prod ucts, oph thal mic prod ucts. Es tab - 

lished 1997. 35 phar ma ceu ti cal employees in 

2008. 


ber): 21-50 (2008) 

Con tacts (Pharm): Chair man: Elgar Schnegg; 

Com mer cial Op er a tions: Guenter Gaspari; Mar ket 

Re search: Elis a beth Zoehling; Re search & De vel - 

op ment: Cornelia Wetton; Gen eral Con tact: Elis a - 

beth Zoehling 

Par ent of: 1A Pharma, Aus tria (100%). 

Sub sid iary of: Sandoz, Aus tria 




5): 65-70% 


95-100% 


OMEC (antiulcerant) 

CARVEDILOL-HEXAL (beta-blocker agent plain) 

SIMVASTATIN-HEXAL (cho les terol/triglyceride 

reg u lat ing prep a ra tion) 

CO-ENAC (ACE in hib i tor com bi na tion) 

AMLODIPIN-HEXAL (cal cium an tag o nist plain) 




beta-block ing agents 10% 



10% 


tab lets 47% 


cap sules 20% 

med i cal dress ings 4% 

liq uids 2% 

NOVARTIS 

Full Name: Novartis Pharma GmbH 



Street Ad dress: Brunnerstrasse 59, A-1235 

Wien 

Tel: +43 1 86 65 70 

Fax: +43 1 86 65 7-575 

Home Page: www.novartispharma.at 

De scrip tion: De vel oper, im porter, dis trib u tor, 




Es tab lished 1997. 2225 phar ma ceu ti cal em ploy - 

ees in 2005. Di vi sions include: Novartis Nutrition. 


ber): 100 (2005) 

Con tacts (Pharm): Chair man: Chris tian 

Seiwald; Com mer cial Op er a tions: 

G.Schroeckenfuchs, H. Irschik-Hadjieff, C. Handl, 

I. Cip, S. Heise-Grubner; Mar ket Re search: Her - 

bert Vorhauer; Re search & De vel op ment: 

Wolfgang Bonitz; Gen eral Con tact: Gabi Kollmann 





5): 45-50% 


80-85% 



CO-DIOVAN (an gio ten sin-II an tag o nist com bi na - 

tion) 


VOLTAREN (antirheumatic non-steroidal; 

antirheumatic top i cal) 

STALEVO (antiparkinson drug) 




vac cines 7% 





cap sules 13% 

vi als 10% 


tab lets 7% 

NOVARTIS CON SUMER HEALTH-GEBRO 

Full Name: Novartis Con sumer Health - Gebro 

GmbH 

Postal Ad dress: Postfach 25, A-6391 

Fieberbrunn 

Street Ad dress: Bahnhofbichl, A-6391 

Fieberbrunn 

Tel: +43 5354 5300 304 

Fax: +43 5354 5300 732 

Email: pharma@gebro.com 

Home Page: www.novartis.at 





non-pre scrip tion), den tal prod ucts, herbal prod - 

ucts. Established 1997. 

Con tacts (Pharm): Chair man: Gerhard Lotsch; 

Com mer cial Op er a tions: Dr Gerhard Loetsch; 

Man u fac ture: Dr G. Hantich; Mar ket Re search: 

Eva Gamerith; Re search & De vel op ment: Dr E. 

Hesse; Gen eral Con tact: Eva Gamerith 




5): 55-60% 


70-75% 


VENORUTON (var i cose ther apy sys temic; var i - 

cose ther apy top i cal) 

FENISTIL (an ti his ta mine sys temic; antipruritic) 

LEMOCIN (throat prep a ra tion) 

VIBROCIL (na sal prep a ra tion top i cal) 

OTRIVIN (na sal prep a ra tion top i cal) 


na sal prep a ra tions 16% 

throat prep a ra tions 15% 

antivaricosis/antihemorrhoidal prep a ra tions 

14% 

wound-heal ing agents 7% 

antidiarrheals, elec tro lyte re plac ers, in tes ti nal 

anti-inflammatorie s 6% 


liq uids 24% 

spe cial solid forms 16% 

cap sules 14% 

tab lets 10% 


SANDOZ 

Full Name: Sandoz GmbH 

Street Ad dress: Brun ner Strasse 59, A-1235 

Wien 

Tel: +43 186 659 750 

Fax: +43 186 659 792 

Home Page: www.sandoz.com 



De scrip tion: Re searcher, de vel oper, man u fac - 

turer, for mu la tor, packager/as sem bler, im porter, 

ex porter, pro moter, sales/detailer. De vel ops, 

man u fac tures, ex ports, sells/de tails for other 

com pa nies. Prod uct ranges in clude: phar ma ceu ti - 

cal prod ucts (branded, unbranded, pre scrip tion), 

hos pi tal pharmaceuticals, in ter me di ates, bio tech - 

nol ogy prod ucts, vet er i nary pharmaceuticals. 


Con tacts (Pharm): Chair man: Chris tian 

Seiwald; Com mer cial Op er a tions: Werner 

Messner; Man u fac ture: Dr Hein rich Scherfler 

Par ent of: Hexal, Aus tria; Lek, Lat via. 





5): 85-90% 


90-95% 


CEFTRIAXON-SANDOZ (cephalosporin) 

CLAVAMOX (pen i cil lin broad spec trum) 

FOSFOMYCIN-SANDOZ (an ti bac te rial other) 

CIPROFLOXACIN-SDZ (fluoroquinolone) 





thy roid ther a pies 6% 






vi als 20% 

tab lets 16% 

liq uids 6% 

BANGLADESH 

NOVARTIS 

Full Name: Novartis (Ban gla desh) Ltd 

Postal Ad dress: PO Box 431, Dhaka 1000 

Street Ad dress: House 50, Road 2A, Dhanmondi 

R.A., Dhaka 1209 

Tel: +880 2 8615302 

Fax: +880 2 8613489 

Email: novartis.bd@novartis.com 

De scrip tion: Man u fac turer, im porter, ex porter, 

dis trib u tor, pro moter, sales/detailer. Prod uct 


(branded, pre scrip tion), di etetic/nu tri tional prod - 

ucts, oph thal mic prod ucts, vet er i nary 

pharmaceuticals. Es tab lished 1997. 588 phar ma - 

ceu ti cal em ploy ees in 2005. Di vi sions in clude: 

Sandoz. Pharma; Sandoz; OTC & MN; Animal 

Health; Ophthalmics. 


ber): 280 (2005) 

Con tacts (Pharm): Chair man: 

Ashfaque-ur-Rahman; Com mer cial Op er a tions: 

M.M. Alam; Man u fac ture: Murshi Siraj Uddin; 

Mar ket Re search: S.A.A. Saher; Gen eral Con tact: 

M.M. Alam 


(group: Novartis, Swit zer land); Ban gla desh 

Chem i cal In dus tries, Ban gla desh (40%) 




5): 80-85% 


95-100% 


VOLTALIN (antirheumatic non-steroidal) 



EXELON (anti-Alz hei mer prod uct) 


a ra tion) 






CNS drugs other 5% 


tab lets 44% 

sup pos i to ries 18% 


cap sules 11% 

am poules 7% 

BELARUS 

NOVARTIS 

Postal Ad dress: 103104 Mos cow, Mos cow Rep - 

re sen ta tive Of fice, 15 B Palashevskiy Pereulok, 

Rus sia 



BELGIUM 

BEXAL 

Full Name: B.V.B.A. Bexal S.P.R.L. 

Street Ad dress: Medialaan 40, bus 1, B-1800 

Vilvoorde 

Tel: +32 2 722 97 97 

Fax: +32 2 722 97 80 

CIBA VI SION 

Full Name: N.V. CIBA Vi sion Ben elux S.A. 

Street Ad dress: Omega Busi ness Park, 

Industrieterrein Mechelen Nord II, 

Wayenborgstraat 22, B-2800 Mechelen 

Tel: +32 1 528 64 00 

Fax: +32 1 528 64 03 

Home Page: www.cibavision.be 


NOVARTIS 

Full Name: Novartis Pharma S.A./N.V. 

Street Ad dress: Medialaan 40, Bus 1, B-1800 

Vilvoorde 

Tel: +32 2 246 16 11 

Fax: +32 2 242 37 59 

Email: brussels.re cep tion@novartis.com 

Home Page: www.novartis.be 

De scrip tion: Dis trib u tor, im porter, pro moter, 



non-pre scrip tion), hos pi tal pharmaceuticals, oph - 

thal mic prod ucts. Es tab lished 1997. 350 phar ma - 

ceu ti cal employees in 2007. 


ber): 101-500 (2007) 

Con tacts (Pharm): Chair man: Tom Rossi; Mar - 

ket Re search: Michel Gravisse; Gen eral Con tact: 

Xa vier Thiriar 





5): 50-55% 


90-95% 



SANDOSTATINE (hor mone hy po tha lamic) 


NEORAL-SANDIMMUN (immunosuppressive 

agent) 


uct) 




hor mones pi tu itary and hy po tha lamic 11% 





vi als 18% 

cap sules 17% 

tab lets 12% 



Street Ad dress: Medialaan 30 bus 5, B-1800 

Vilvoorde 

Tel: +32 2 264 97 00 

Fax: +32 2 264 97 05 

De scrip tion: Dis trib u tor, pro moter, 


ceu ti cal prod ucts (branded, non-pre scrip tion), 

hos pi tal pharmaceuticals. Es tab lished 1923. 61 

phar ma ceu ti cal em ploy ees in 2008. Di vi sions 

include: Self-Medication. 


ber): 20 (2008) 

Con tacts (Pharm): Chair man: Guy Rombouts; 

Com mer cial Op er a tions: Guido Van Hoeck; Mar - 

ket Re search: Bart Wellens; Re search & De vel op - 

ment: Pieter De Pourcq 





5): 85-90% 


85-90% 


VOLTAREN EMULGEL (antirheumatic top i cal) 

OTRIVINE (na sal prep a ra tion top i cal; na sal prep - 

a ra tion sys temic) 

OROFAR (throat prep a ra tion) 



VOLTAPATCH TISSUGE (antirheumatic top i cal) 


anti rheu ma tics top i cal 33% 




14% 





gels/sols 26% 

liq uids 25% 



tab lets 10% 

SANDOZ 

Full Name: N.V. Sandoz S.A. 

Street Ad dress: Medialaan 40, bus 1, B-1800 

Vilvoorde 

Tel: +32 2 722 97 97 

Fax: +32 2 722 97 90 

De scrip tion: Sales/detailer. Prod uct ranges in - 

clude: phar ma ceu ti cal prod ucts (pre scrip tion, 

non-pre scrip tion). 85 phar ma ceu ti cal em ploy ees 

in 2008. 


ber): 63 (2008) 

Con tacts (Pharm): Chair man: Dominique Pe tit; 

Com mer cial Op er a tions: Dominique Pe tit (Sales), 

Vin cent Verschraegen (Mar ket ing) 





5): 65-70% 


95-100% 


OMEPRAZOL SANDOZ (antiulcerant) 

SIMVASTATINE-BXA (cho les terol/triglyceride 


AMOXICLAV SANDOZ (pen i cil lin broad spec trum) 

AMLODIPINE-BXA (cal cium an tag o nist plain) 

CEFAZOLINE SANDOZ (cephalosporin) 





14% 





tab lets 30% 

cap sules 23% 

vi als 6% 

liq uids 3% 

BOSNIA-HERZEGOVINA 

LEK 

Full Name: Lek Predstavnistvo Sarajevo BiH 

Street Ad dress: 71000 Sarajevo, Antuna 

Hangija B.B., Poslovni Centar 

Tel: +387 33 44 03 28 

Fax: +387 33 44 10 81 

Email: lek.bh@bih.net.ba 

De scrip tion: Rep re sen ta tive of fice. Pro moter, 




herbal prod ucts. Es tab lished 1996. 13 phar ma - 



ber): 9 (2006) 

Con tacts (Pharm): Chair man: Dukic Nudzeim; 

Com mer cial Op er a tions: Alma Krilic; Mar ket Re - 

search: Alma Krilic; Gen eral Con tact: Dukic 

Nudzeim, Alma Krilic 

BRAZIL 

HEXAL 

Full Name: Hexal Do Brasil Ltda 

Street Ad dress: Avenida Itaborai 1425, 

04135-001 Bosque da Saude SP 

Tel: +55 11 5591 7600 

Fax: +55 11 3174 8000 

Email: hexal.brasil@hexal.com.br 

Home Page: www.hexal.com.br 




ceu ti cal prod ucts. Es tab lished 1999. 

Con tacts (Pharm): Chair man: R.A. Nordmann; 

Com mer cial Op er a tions: F. Cesar Ayala; Man u - 

fac ture: Wil son Goncalves; Mar ket Re search: 

Eraldo Lustoza; Re search & De vel op ment: Luis 

Rogerio M. da Silda; Gen eral Con tact: Thomas 

Offenhaussen 

NOVARTIS 

Full Name: Novartis Biociencias S.A. 

Postal Ad dress: Caixa Postal 21460, 04706-900 

Sao Paulo SP 

Street Ad dress: Av Prof. Vicente Rao 90, 

04636-000 Sao Paulo SP 

Tel: +55 11 5532 7122 

Fax: +55 11 5532 4175 

Home Page: www.novartis.com.br 





trib u tor, pro moter, sales/detailer. Man u fac tures 

for other com pa nies. Prod uct ranges in clude: 

phar ma ceu ti cal prod ucts (branded, unbranded, 

pre scrip tion, non-pre scrip tion), hos pi tal 

pharmaceuticals, fine chem i cals, raw ma te ri als, 

bio tech nol ogy prod ucts, oph thal mic prod ucts, 

vet er i nary pharmaceuticals. Es tab lished 1997. 

1,438 phar ma ceu ti cal em ploy ees in 2007. 

Divisions include: Novartis Consumer Health. 


ber): 595 (2007) 

Con tacts (Pharm): Chair man: Al ex an der 

Triebnigg; Com mer cial Op er a tions: Marcelo 

Morkoski; Man u fac ture: Valdemar Grober; Mar - 

ket Re search: Camila Finzi; Re search & De vel op - 

ment: An dre Feher; Gen eral Con tact: Celso 

Massatoshi Sato 





5): 65-70% 


95-100% 


DIOVAN HCT (an gio ten sin-II an tag o nist com bi na - 

tion) 


PREXIGE (antirheumatic non-steroidal) 

FORASEQ (B2-stim u lant/corticoid com bi na tion) 










tab lets 24% 

cap sules 17% 

liq uids 4% 


SANDOZ 

Full Name: Sandoz do Brasil In du stria 

Farmaceutica Ltda. 

Street Ad dress: Av. Itaborai, 1425, Bosque da 

Saude, 04135-001 Sao Paulo SP 

Tel: +55 11-5591 7600 

Fax: +55 11-5591 7600 





5): 45-50% 


95-100% 


SINVASTACOR (cho les terol/triglyceride reg u lat - 

ing prep a ra tion) 

SINVASTATINA MG (cho les terol/triglyceride reg - 

u lat ing prep a ra tion) 

CLOPIDOGREL MG (platelet ag gre ga tion in hib i tor) 

AMIDALIN (throat prep a ra tion) 

CLO SIBUTRAMINA MG (antiobesity prep a ra tion 

non-di etetic) 





10% 




tab lets 42% 


cap sules 13% 


liq uids 3% 

BULGARIA 

HEXAL 

Street Ad dress: Et. 1, App. 3, 19, “Tzar Assen” 

Street, 1000 So fia 

De scrip tion: Rep re sen ta tive of fice. Es tab lished 

2000. 

Con tacts (Pharm): Chair man: Dr Ray Masch 

NOVARTIS 

Full Name: Novartis Pharma Ser vices Inc 

Street Ad dress: Busi ness Park So fia, Build ing 

8C, 6th floor, 1766 So fia 

Tel: +359 2 489 9828 

Fax: +359 2 489 9829 


De scrip tion: Rep re sen ta tive of fice. Prod uct 

ranges in clude: phar ma ceu ti cal prod ucts. 45 

phar ma ceu ti cal em ploy ees in 2008. Di vi sions in - 

clude: Novartis Consumer Health. 




ber): 24 (2008) 

Con tacts (Pharm): Chair man: Elena Mitova 




5): 60-65% 


90-95% 




FEMARA (cytostatic hor mone an tag o nist) 


LEPONEX (antipsychotic) 






cytostatic hor mone ther apy 11% 



tab lets 24% 

cap sules 22% 


liq uids 5% 

SANDOZ 

Full Name: Sandoz Pharmaceuticals d.d. 

Street Ad dress: Busi ness Park So fia, Build ing 8, 

floor 6, 1715 So fia 

Tel: +359 2 970 4747 

Fax: +359 2 970 4757 

De scrip tion: Rep re sen ta tive of fice. 




5): 70-75% 


80-85% 


OSPAMOX (pen i cil lin broad spec trum) 

DICLAC (antirheumatic non-steroidal; 


AMOKSIKLAV (pen i cil lin broad spec trum) 

OSPEXIN (cephalosporin) 

LOPEDIUM (mo til ity in hib i tor) 




cough and cold prep a ra tions 7% 

an ti bi ot ics, sulphonamides and antivirals top i cal 

6% 





tab lets 22% 

cap sules 11% 

liq uids 9% 

am poules 7% 

CANADA 

CIBA VI SION 

Full Name: CIBA Vi sion Can ada Inc. 

Street Ad dress: 2150 Torquay Mews, 

Mississauga, On tario, L5N 2M6 

Tel: +1 905 821-4774 

Fax: +1 905 821-8106 

Home Page: www.cibavision.ca 


NOVARTIS 

Full Name: Novartis Pharmaceuticals Can ada Inc 

Street Ad dress: 385 Bouchard Bou le vard, 

Dorval, Que bec, H9S 1A9 

Tel: +1 514 631-6775 

Fax: +1 514 631-1867 

Home Page: www.pharma.ca.novartis.com 

De scrip tion: Re searcher, man u fac turer, 

packager/as sem bler, im porter, ex porter, dis trib - 

u tor, pro moter, sales/detailer. Prod uct ranges in - 

clude: phar ma ceu ti cal prod ucts (branded, 

pre scrip tion), hos pi tal pharmaceuticals, bio tech - 

nol ogy prod ucts. Established 1997. 

Con tacts (Pharm): Chair man: Ian Clark; Com - 

mer cial Op er a tions: Fran cis Bouchard (Sales), 

John Dorsey (Mar ket ing); Man u fac ture: Dr Stan - 

ley Brame; Mar ket Re search: Dr Loic Maurel 

Par ent of: Novartis Con sumer Health, Can ada 

(100%); Novartis Ophthalmics, Can ada (di vi - 

sion). 





5): 60-65% 


90-95% 



GLEEVEC (antineoplastic other) 




tion) 

CLOZARIL (antipsychotic) 

SANDOSTATIN LAR (hor mone hy po tha lamic) 





psycholeptics 8% 




tab lets 19% 

vi als 12% 

cap sules 11% 

liq uids 4% 


Full Name: Novartis Con sumer Health Can ada 

Inc 

Street Ad dress: 2233 Argentia Road, Floor 2, 

Suite 205, West Tower, Mississauga, On tario, L5N 

2X7 

Tel: +1 905 812-4100 

Fax: +1 905 821-4936 

Home Page: www.novartisconsumerhealth.ca 

De scrip tion: De vel oper, man u fac turer, dis trib u - 

tor, pro moter, sales/detailer. Prod uct ranges in - 

clude: phar ma ceu ti cal prod ucts 

(non-pre scrip tion), di ag nos tic prod ucts. Es tab - 


2007. 


ber): 0 (2007) 

Con tacts (Pharm): Chair man: Rick Lloyd; Com - 

mer cial Op er a tions: Craig Miles; Man u fac ture: 

Norma Pirie; Re search & De vel op ment: Don 

Beatty; Gen eral Con tact: Chris Dunsmuir 

Sub sid iary of: Novartis, Can ada (100%) 




5): 75-80% 


85-90% 



BUCKLEYS COUGH MIX (antitussive) 

HABITROL (antismoking prod uct) 

NEO CITRAN (cold prep a ra tion with out anti-in fec - 

tive; antitussive; an ti his ta mine sys temic) 

EX-LAX (lax a tive) 





lax a tives 9% 



liq uids 40% 

tab lets 17% 




NOVARTIS OPHTHALMICS 

Full Name: Novartis Ophthalmics,, A Di vi sion of 

Novartis Pharmaceuticals (Can ada) Inc 

Street Ad dress: 2233 Argentia Road, East 

Tower, Suite 200, Mississauga, On tario, L5N 2X7 

Tel: +1 905 813-6550 

De scrip tion: Dis trib u tor, sales/detailer. Prod uct 

ranges in clude: oph thal mic prod ucts. Es tab lished 

1990. 


ber): 21-50 (2005) 

Con tacts (Pharm): Chair man: John 

Snisarenko; Com mer cial Op er a tions: Deb bie King 

Sub sid iary of: Novartis, Can ada (di vi sion) 

SANDOZ 

Full Name: Sandoz Can ada Inc. 

Street Ad dress: 145 Jules-Leger, Boucherville, 

Que bec, J4B 7K8 

Tel: +1 450 641-4903 

Fax: +1 514 596-1460 

Home Page: www.sandoz.ca 



trib u tor, pro moter, sales/detailer. Man u fac tures, 

dis trib utes, pro motes, sells/de tails for other com - 

pa nies. Prod uct ranges in clude: phar ma ceu ti cal 

prod ucts (branded, unbranded, pre scrip tion, 


thal mic prod ucts. Es tab lished 1980. 570 



ber): 21-50 (2007) 

Con tacts (Pharm): Chair man: Pi erre Frechette; 

Com mer cial Op er a tions: Jacques Bergeron; Man - 

u fac ture: Bruce Levins; Mar ket Re search: Terri 

Power; Re search & De vel op ment: Su zanne 

Levesque; Gen eral Con tact: Pierre Frechette 







5): 40-45% 


85-90% 


SANDOZ-DILTIAZEM T (cal cium an tag o nist plain) 

SANDOZ-BUPROPRION (an ti de pres sant) 

SANDOZ-FELODIPINE (cal cium an tag o nist plain) 

SANDOZ-BISOPROLOL (beta-blocker agent plain) 

SUPEUDOL (an al ge sic nar cotic) 



an al ge sics 10% 



an es thet ics 6% 


vi als 33% 


tab lets 16% 

cap sules 11% 

am poules 8% 

CHILE 

NOVARTIS 

Full Name: Novartis Chile SA 

Postal Ad dress: Casilla Correo 9993, San ti ago 

de Chile 

Street Ad dress: Rosario Norte 615, Piso 9, 

Edificio Mis tral - Las Condes, San ti ago de Chile 

Tel: +56 2 3500200 

Fax: +56 2 2244283 

Email: novartis.chile@pharma.novartis.com 

Home Page: www.novartis.cl 





thal mic prod ucts, vet er i nary pharmaceuticals. Es - 

tab lished 1997. Di vi sions include: Novartis Self 

Med. 

Con tacts (Pharm): Chair man: James Har old; 

Com mer cial Op er a tions: James Har old; Man u fac - 

ture: Jac que line Cas tro; Mar ket Re search: Julio 

Sanhueza; Re search & De vel op ment: Elisa 

Berdichevsky; Gen eral Con tact: Monica Zell K. 





5): 65-70% 


90-95% 


TAREG-D (an gio ten sin-II an tag o nist com bi na - 

tion) 


NEO-SINTROM (vi ta min K an tag o nist) 

CATAFLAM (antirheumatic non-steroidal) 









tab lets 41% 


cap sules 9% 

liq uids 7% 


CHINA 

CHIRON 

Street Ad dress: 14th Floor - IBM Tower, Pa cific 

Cen tury Place, Chaoyang Dis trict, Beijing, 

1000027 

Tel: +86 10 65391262 

Fax: +86 10 65391060 

Email: info@chironvaccines.com 

HEXAL 

Full Name: Tianjin Hexal Phar ma ceu ti cal Co. Ltd 

Street Ad dress: Fujiang Road, Xijiangjing, 

Xiqing Dis trict, Tianjin, 300112 

Tel: +86 22 27539488 

Fax: +86 22 27513010 

Sub sid iary of: Sandoz, Ger many (joint) 

NOVARTIS 

Full Name: Beijing Novartis Pharma Ltd 

Street Ad dress: 14/F, China World Tower 2, No. 

1 Jian Guo Men Wai Ave, Chaoyang Dis trict, 

Beijing, 100004 

Tel: +86 10 65058833 

Fax: +86 10 65057311 

Home Page: www.pharma-novartis.com.cn 


bler, im porter, ex porter, pro moter, sales/detailer. 



Prod uct ranges in clude: phar ma ceu ti cal prod ucts 


tal pharmaceuticals, oph thal mic prod ucts. Es tab - 

lished 1987. Di vi sions include: Novartis Beijing. 

Con tacts (Pharm): Chair man: Dai Hao Sen, 

James Liu; Com mer cial Op er a tions: James Deng; 

Man u fac ture: Jurg Steiner; Mar ket Re search: 

John son Ye; Gen eral Con tact: Hu Ping 





5): 70-75% 


90-95% 



SANDOSTATIN (hor mone hy po tha lamic) 

SANDIMMUN NEORAL (immunosuppressive 

agent) 

MIACALCIC (calcitonin) 






hor mones other 10% 



cap sules 50% 

am poules 26% 



tab lets 5% 

COLOMBIA 

NOVARTIS 

Full Name: Novartis de Co lom bia S.A. 

Postal Ad dress: Apartado Aereo 12323, Bo gota 

Street Ad dress: Calle 11 No. 65-51, Bo gota 

12323 

Tel: +57 1 420 6100/420 6055 

Fax: +57 1 290 2244 

Home Page: www.novartis.com.co 


sales/detailer. Im ports, dis trib utes, pro motes, 


in clude: phar ma ceu ti cal prod ucts (branded, pre - 

scrip tion, non-pre scrip tion), hos pi tal 

pharmaceuticals, oph thal mic prod ucts, op ti cal 

instruments. Established 1997. 

Con tacts (Pharm): Chair man: An dre Brazay; 

Com mer cial Op er a tions: Maria Cristina Alvarez; 

Mar ket Re search: Beatriz Ramirez Montero; Re - 

search & De vel op ment: Maria Cristina Eslava; 

Gen eral Con tact: Beatriz Ramirez Montero 





5): 60-65% 


75-80% 


VOLTAREN (antirheumatic non-steroidal) 

MEBUCAINA (throat prep a ra tion) 


tion) 


GENTEAL (ar ti fi cial tears/oc u lar lu bri cant) 









tab lets 20% 

liq uids 13% 


cap sules 8% 

SANDOZ 

Street Ad dress: Calle 11 No. 65-51, Bo gota 

Tel: +57 1 420 6100/420 6055 

Fax: +57 1 420 8309 

De scrip tion: Packager/as sem bler, ex porter, 

sales/detailer. Man u fac tures, man u fac tures for 

other com pa nies. Prod uct ranges in clude: phar - 

ma ceu ti cal prod ucts (branded, unbranded, pre - 


pharmaceuticals. Established 1996. 

Con tacts (Pharm): Chair man: Nestor Chavez 

Mar ti nez 




5): 85-90% 


85-90% 




BENZETACIL LA (pen i cil lin me dium/nar row spec - 

trum) 

CURAM (pen i cil lin broad spec trum) 

PEN-VEE K (pen i cil lin me dium/nar row spec trum) 

SERVAMOX (pen i cil lin broad spec trum) 

TAMSULOSINA (BPH (be nign pros tatic hy per tro - 

phy) prod uct) 





6% 




tab lets 24% 

vi als 21% 

liq uids 17% 

cap sules 15% 


CROATIA 

LEK 

Full Name: Lek Zagreb d.o.o. 

Street Ad dress: 10000 Zagreb, Maksimirska 

120 

Tel: +385 1 2353 111 

Fax: +385 1 2337 785 

Con tacts (Pharm): Chair man: Alojz Pungarsek; 

Gen eral Con tact: Alojz Pungarsek 





5): 50-55% 


90-95% 


AMLOPIN (cal cium an tag o nist plain) 

TU LIP (cho les terol/triglyceride reg u lat ing prep a - 

ra tion) 

SANVAL (hyp notic/sed a tive) 

OPERIL (na sal prep a ra tion top i cal) 

LEKADOL (an al ge sic non-nar cotic) 




13% 





tab lets 44% 


cap sules 10% 

liq uids 7% 

pres sur ised aero sols 5% 

NOVARTIS 

Full Name: Novartis Pharma d.o.o. 

Street Ad dress: 10000 Zagreb, Zaharova 7b, 

2nd Floor 

Tel: +385 1 6274 220 

Fax: +385 1 6274 255 

Con tacts (Pharm): Gen eral Con tact: Denis 

Vujicic 




5): 80-85% 


95-100% 



a ra tion) 



tion) 



agent) 




22% 





cap sules 44% 


tab lets 20% 

liq uids 2% 


CZECH REPUBLIC 

CHIRON 

Street Ad dress: Hviezdoslavova, 627 00 Brno 

Tel: +420 5 48213610 

Fax: +420 5 48213611 




LEK 

Full Name: Lek Pharma s. r. o. 

Street Ad dress: Jeseniova 30, 130 00 Praha 3 

Tel: +420 2 21421611/21421613 

Fax: +420 2 21421629/21421630 

Email: lekcz@lekpharma.anet.cz 


Con tacts (Pharm): Chair man: Joze Kavticnik; 

Gen eral Con tact: Joze Kavticnik 

NOVARTIS 

Full Name: Novartis s.r.o. 

Street Ad dress: Nagano III., U Nakladoveho 

nadrazi 10, 130 00 Praha 

Tel: +420 2 25775111 

Fax: +420 2 25775222 

Home Page: www.novartis.cz 

De scrip tion: De vel oper, pro moter, 




oph thal mic prod ucts, vet er i nary pharmaceuticals. 

Es tab lished 1996. Di vi sions in clude: Novartis 

Consumer Health. 

Con tacts (Pharm): Chair man: Roger Meij; 

Com mer cial Op er a tions: Pavel Kral; Mar ket Re - 

search: Lenka Rysava; Gen eral Con tact: Iveta 

Kotaskova 





5): 55-60% 


95-100% 




GLYVENOL (var i cose ther apy sys temic) 



agent) 






9% 




cap sules 29% 

tab lets 9% 


liq uids 5% 

SANDOZ 

Full Name: Sandoz s.r.o. 

Street Ad dress: Jeseniova 30, 130 00 Praha 3 

Tel: +420 2 21421611 

Fax: +420 2 21421629 





5): 60-65% 


95-100% 




ra tion) 

GINGIO (ce re bral/pe riph eral vasotherapeutic) 

ACC LONG (ex pec to rant) 

PIRAMIL (ACE in hib i tor plain) 




10% 

ce re bral/pe riph eral vasotherapeutics 9% 





tab lets 29% 

vi als 15% 

cap sules 8% 

am poules 5% 

DENMARK 

HEXAL 

Full Name: Hexal A/S 

Street Ad dress: Kanalholmen 8-12, DK-2650 

Hvidovre 

Tel: +45 38 34 42 42 

Fax: +45 38 34 11 23 

Email: info@hexal.dk 

Home Page: www.hexal.dk 

De scrip tion: De vel oper, man u fac turer, ex - 

porter, dis trib u tor, sales/detailer. Pro motes, 


in clude: phar ma ceu ti cal prod ucts (non-pre scrip - 



tion). Es tab lished 1927. 220 phar ma ceu ti cal 

employees in 2005. 


ber): 1-10 (2005) 

Con tacts (Pharm): Chair man: Karsten H. 

Skaffe, Jeanette Stids-Jonsby; Com mer cial Op er - 

a tions: Birgit Larsen; Gen eral Con tact: Jeanette 

Stids-Jonsby 




5): 75-80% 



METOPROLOLSUCC HEX (beta-blocker agent 

plain) 

CORODIL (ACE in hib i tor plain) 

SIMVASTATIN HEXAL (cho les terol/triglyceride 


AMLODIPIN HEXAL (cal cium an tag o nist plain) 

ORABET (antidiabetic oral) 








tab lets 76% 


cap sules 3% 

am poules - 

NOVARTIS 

Full Name: Novartis Healthcare A/S 

Street Ad dress: Lyngbyvej 172, DK-2100 

Kobenhavn 

Tel: +45 39 16 84 00 

Fax: +45 39 16 84 01 

Email: skriv.til@novartis.com 

Home Page: www.novartis.dk 

De scrip tion: Re searcher, im porter, pro moter, 




di etetic/nu tri tional prod ucts, oph thal mic prod - 

ucts, vet er i nary pharmaceuticals. Es tab lished 

1997. 148 phar ma ceu ti cal em ploy ees in 2007. Di - 

vi sions in clude: Novartis Pharmaceuticals. 

Pharma; Con sumer Health; An i mal Health; 

Sandoz; Medical Nutrition. 


ber): 21-50 (2007) 

Con tacts (Pharm): Chair man: Ja son Smith; 

Com mer cial Op er a tions: Ja son Smith; Mar ket Re - 

search: Thomas Klaening; Re search & De vel op - 

ment: Jan Narvestad; Gen eral Con tact: Thomas 

Klaening 





5): 55-60% 


75-80% 



NICOTINELL MINT (antismoking prod uct) 

RITALIN UNO (psychostimulant) 












cap sules 14% 

liq uids 10% 


SANDOZ 

Full Name: Sandoz A/S 

Street Ad dress: C. F. Tietgens Bou le vard 40, 

DK-5220 Odense S 

Tel: +45 63 95 10 00 

Fax: +45 63 95 10 01 

Email: info.sandoz-dk@sandoz.com 

Home Page: www.sandoz.dk 

De scrip tion: De vel oper, man u fac turer, 


u tor, pro moter, sales/detailer. Prod uct ranges in - 



pharmaceuticals, bi o log i cal prod ucts. Es tab lished 

1982. 120 pharmaceutical employees in 2008. 


ber): 8 (2008) 

Con tacts (Pharm): Chair man: Olof Milveden; 

Com mer cial Op er a tions: Erik Furstrung; Man u - 



fac ture: Niels Hansen; Mar ket Re search: Mogens 

Skov; Gen eral Con tact: Pernille Marhaver 

Par ent of: Sandoz AB, Swe den. 





5): 60-65% 


95-100% 


DICILLIN (pen i cil lin me dium/nar row spec trum) 

NOVYNETTE (hor monal con tra cep tive sys temic) 

ISODUR (ni trite/ni trate) 

LINDYNETTE (hor monal con tra cep tive sys temic) 

MANDOLGIN (an al ge sic non-nar cotic) 



sex hor mones sys temic 18% 






tab lets 30% 

cap sules 27% 

am poules 4% 

vi als 1% 

DOMINICAN REPUBLIC 

NOVARTIS 

Full Name: Novartis Caribe S.A. 

Postal Ad dress: Apartado Postal 736, Santo 

Domingo 

Street Ad dress: Av. 27 de Febrero, No. 18 

Miraflores, Santo Domingo 

Tel: +1 809 686-7676 

Fax: +1 809 687-7972 


sales/detailer. Im ports, dis trib utes for other com - 


prod ucts (branded, pre scrip tion, non-pre scrip - 

tion), hos pi tal pharmaceuticals, vet er i nary 

pharmaceuticals. Es tab lished 1997. Di vi sions 

include: Biochemie. 

Con tacts (Pharm): Chair man: Diego Cuesta; 

Com mer cial Op er a tions: Rob ert O’Sullivan 




5): 80-85% 


90-95% 




tion) 


DIOVAN FCT (an gio ten sin-II an tag o nist plain) 

PANTECTA (antiulcerant) 









tab lets 16% 

cap sules 16% 

liq uids 6% 


SANDOZ 

Street Ad dress: Ho tel Do min i can Fi esta, 

Avenida Anacaona, Los Casicaszgos, Santo 

Domingo 

Tel: +1 809 482-5701 

Fax: +1 809 482-3310 

Email: sandoz@codetel.net.do 

De scrip tion: 18 phar ma ceu ti cal em ploy ees in 

2007. 


ber): 15 (2007) 

Con tacts (Pharm): Chair man: Da vid Thomp - 

son; Com mer cial Op er a tions: Da vid Thomp son; 

Gen eral Con tact: Da vid Thompson 

ECUADOR 

NOVARTIS 

Full Name: Novartis Ec ua dor SA 

Postal Ad dress: Casilla 17-11-06201, Quito 

Street Ad dress: Av Republico de El Sal va dor, 

N34-107 y Suiza, Ed. Brescia Piso 4, Quito 

Tel: +593 2 246-4054 

Fax: +593 2 246-1394 

De scrip tion: Packager/as sem bler, im porter, dis - 

trib u tor, pro moter, sales/detailer. Prod uct ranges 


scrip tion, non-pre scrip tion), oph thal mic prod ucts. 


in 2005. Di vi sions in clude: Novartis Con sumer 



Health. Pharmaceuticals; Con sumer Healthcare; 

Ophthalmics; Optics; Branded Generics. 


ber): 51-100 (2005) 

Con tacts (Pharm): Chair man: Maria Cristina 

Alvarez; Com mer cial Op er a tions: Javier Gabela; 

Mar ket Re search: Mil ton Mo rales; Re search & De - 

vel op ment: Edwin Cabrera; Gen eral Con tact: 

Milton Morales 

Par ent of: Sandoz, Ec ua dor (di vi sion). 





5): 75-80% 


90-95% 




tion) 



PREXIGE (antirheumatic non-steroidal) 









tab lets 21% 

liq uids 14% 

cap sules 5% 

am poules 3% 


Full Name: Novartis Ec ua dor S.A. 


Street Ad dress: Av. Republica del Sal va dor 

N34-107 y Suiza, Edificio Brescia 3, 4, 5 to Piso, 

Quito 

Tel: +593 2 246-4039 

Fax: +593 2 246-1394 


De scrip tion: Packager/as sem bler, ex porter, dis - 

trib u tor. Prod uct ranges in clude: phar ma ceu ti cal 


tion), oph thal mic prod ucts. Es tab lished 1997. 130 



ber): 51-100 (2006) 

Con tacts (Pharm): Chair man: Maria Cristina 

Alvarez; Com mer cial Op er a tions: Javier Gabela; 

Mar ket Re search: Paul Solorzano; Re search & De - 

vel op ment: Edwin Cabrera; Gen eral Con tact: Mil - 

ton Morales 

SANDOZ 


Street Ad dress: Av. Republica del Sal va dor 

N34-107 y Suiza, Edificio Brescia, 3rd Piso Of. 

301, Quito 

Tel: +593 2 246-4422 

Fax: +593 2 225-1952 




hos pi tal pharmaceuticals. Es tab lished 1989. 27 



ber): 20 (2006) 

Con tacts (Pharm): Chair man: Harry Yepez 

Meisner; Com mer cial Op er a tions: Harry Yepez 

Meisner; Mar ket Re search: Marcela Carrillo; Gen - 

eral Con tact: Harry Yepez Meisner 

Sub sid iary of: Novartis, Ec ua dor (di vi sion) 




5): 90-95% 


90-95% 



BINOZYT (macrolide/sim i lar type) 

BENZETACIL (pen i cil lin me dium/nar row spec - 

trum) 

BIODROXIL (cephalosporin) 

SERVAMOX (pen i cil lin broad spec trum) 



antifungals sys temic 4% 






liq uids 26% 

tab lets 15% 

cap sules 13% 

vi als 10% 



EGYPT 

HEXAL 

Full Name: Hexal Egypt S.A.E. 

Street Ad dress: 51 Bei rut Street, Heliopolis, 

Cairo 

Tel: +20 2 6907017 

Fax: +20 2 6907019 

Home Page: www.sandoz.com.eg 

Con tacts (Pharm): Chair man: Sany Issa 

NOVARTIS 

Full Name: Novartis Pharma S.A.E. 

Postal Ad dress: PO Box 1893, Cairo 11511 

Street Ad dress: El Sawah St, Amiria, Cairo 

11511 

Tel: +20 2 2593990 

Fax: +20 2 4505345 



packager/as sem bler, im porter, dis trib u tor, pro - 

moter, sales/detailer. Man u fac tures for other 


cal prod ucts (branded, unbranded, pre scrip tion, 


lished 1997. 367 phar ma ceu ti cal em ploy ees in 

2005. Di vi sions in clude: Novartis Pharma. 

Pharmaceuticals; Con sumer Health; Generics; 

Ciba Vision; Sandoz. 


ber): 101-500 (2005) 

Con tacts (Pharm): Chair man: Hansjuergen 

Beger; Com mer cial Op er a tions: Frederic 

Guerard; Man u fac ture: Alaa Nashaat; Mar ket Re - 

search: Walid Saafan; Re search & De vel op ment: 

S. El Sharkway 





5): 75-80% 


85-90% 






CATAFAST (antirheumatic non-steroidal) 






gynecologicals other 6% 


tab lets 26% 


am poules 19% 

cap sules 14% 



Full Name: Novartis Egypt (Healthcare) S.A.E. 

Street Ad dress: 12 El Rabiee Street, (of Ahmed 

Hosny Street), 1st Zone, Nasr City, Cairo 11511 

Tel: +20 2 4052180 

Fax: +20 2 4052184 

Email: nch.egypt@novartis.com 

Home Page: 

www.consumerhealth.eg.novartis.com 



u tor, pro moter, sales/detailer. Packs/as sem bles, 

im ports, ex ports, dis trib utes for other com pa nies. 


(branded, pre scrip tion, non-pre scrip tion), di - 

etetic/nu tri tional prod ucts, herbal products, 

medical supplies. 

Con tacts (Pharm): Chair man: Ali Ghamraioy 





5): 70-75% 


90-95% 



SPASMO CANULASE D (di ges tive in clud ing en - 

zymes) 

VOLTAREN C.H. (antirheumatic top i cal; 

antirheumatic non-steroidal) 

BRADORAL (throat prep a ra tion) 

FENISTIL (an ti his ta mine sys temic; antipruritic) 



di ges tives in clud ing di ges tive en zymes 16% 





liq uids 29% 


gels/sols 16% 




tab lets 8% 

ESTONIA 

NOVARTIS 

Full Name: Novartis Pharma Ser vices AG 

Street Ad dress: Peterburi tee 47, 11415 Tallinn 

Tel: +372 6 062400 

Fax: +372 6 062409 

De scrip tion: Rep re sen ta tive of fice. Pro moter, 


ceu ti cal prod ucts (branded, pre scrip tion), hos pi tal 

pharmaceuticals, oph thal mic prod ucts. Es tab - 


2007. Di vi sions in clude: Novartis Con sumer 

Health. General Medicines; Oncology. 


ber): 1-10 (2007) 

Con tacts (Pharm): Chair man: Roland Lepik 




5): 75-80% 


95-100% 



agent) 












cap sules 52% 

tab lets 42% 


creams 2% 

am poules 1% 

SANDOZ 


Street Ad dress: Parnustr. 105, 11312 Tallinn 

Tel: +372 6 652400 

Fax: +372 6 652410 

Home Page: www.sandoz.ee 

De scrip tion: Rep re sen ta tive of fice. Pro moter. 


(pre scrip tion, non-pre scrip tion), herbal prod ucts. 

Es tab lished 2002. 14 phar ma ceu ti cal employees 

in 2007. 


ber): 11-20 (2007) 

Con tacts (Pharm): Chair man: Agre Jarvelaid; 

Com mer cial Op er a tions: Tiiu Kalmet; Gen eral 

Con tact: Viivian Taal 




5): 60-65% 


95-100% 


RAMICOR (ACE in hib i tor plain) 

DICLAC (antirheumatic top i cal; antirheumatic 

non-steroidal) 

AMLOCARD (cal cium an tag o nist plain) 

CO-RAMICOR (ACE in hib i tor com bi na tion) 

ACC (ex pec to rant) 





10% 




tab lets 73% 


gels/sols 7% 

cap sules 6% 


FINLAND 

CIBA VI SION 

Full Name: CIBA Vi sion Fin land Oy 

Street Ad dress: Metsanneidonkuja 10, 

FIN-02130 Espoo 

Tel: +358 9 20340004 

Fax: +358 9 20340010 

Home Page: www.cibavision.fi 

HEXAL 

Full Name: Oy Hexal AB 

Street Ad dress: Rajatorpantie 41C, FIN-01640 

Vantaa 

Tel: +358 9 8520 2030 



Fax: +358 9 8520 2034 

Email: firstname.lastname@hexal.fi 

Home Page: www.hexal.fi 

De scrip tion: Pro moter. Prod uct ranges in clude: 

phar ma ceu ti cal prod ucts (branded, unbranded, 





ber): 7 (2005) 

Con tacts (Pharm): Chair man: Timo Nurmi; 

Com mer cial Op er a tions: Marko Sandberg; Gen - 

eral Con tact: Mari Wuori 




5): 70-75% 


95-100% 


LINATIL COMP (ACE in hib i tor com bi na tion) 

LIPCUT (cho les terol/triglyceride reg u lat ing prep a - 

ra tion) 

GEFINA (BPH (be nign pros tatic hy per tro phy) 

prod uct) 

METOHEXAL (beta-blocker agent plain) 

LINATIL (ACE in hib i tor plain) 




14% 



antigout prep a ra tions 8% 


tab lets 53% 


cap sules 4% 


creams 2% 

NOVARTIS 

Full Name: Novartis Fin land Oy 

Street Ad dress: Metsaenneidonkuja 10, 


Tel: +358 96 133 2211 

Fax: +358 98 550 0003 

Home Page: www.novartis.fi 

De scrip tion: Re searcher, im porter, pro moter. 



tal pharmaceuticals, oph thal mic prod ucts, vet er i - 

nary pharmaceuticals. Es tab lished 1997. 125 


clude: Pharmaceuticals; Consumer Health 


ber): 51-100 (2008) 

Con tacts (Pharm): Chair man: Antti Viitanen; 

Com mer cial Op er a tions: Merja 

Lankinen-Liflander, Alexis Burekhardt; Mar ket 

Re search: Jaana-Liisa Aro; Re search & De vel op - 

ment: Maarit Hillila; Gen eral Con tact: Jaana-Liisa 

Aro 





5): 55-60% 


85-90% 




SANDIMMUN (immunosuppressive agent) 


DIOVAN COMP (an gio ten sin-II an tag o nist com bi - 

na tion) 









cap sules 22% 

tab lets 13% 

am poules 7% 

liq uids 7% 


Full Name: Novartis Fin land Oy 

Street Ad dress: Metsanneidonkuja 10, 


Tel: +358 9 6133 2211 

Fax: +358 9 6133 2200 

Home Page: www.novartis.fi 

De scrip tion: Im porter, pro moter, sales/detailer. 


(branded, unbranded, pre scrip tion, non-pre scrip - 

tion), hos pi tal pharmaceuticals, vet er i nary 

pharmaceuticals, oph thal mic prod ucts. Es tab - 




2005. Di vi sions in clude: Pharma; Con sumer 

Health; Sandoz (generics). 

Con tacts (Pharm): Chair man: Torbjorn Sonck; 

Mar ket Re search: Jaana-Loisa Aro; Re search & 

De vel op ment: Mika Makea; Gen eral Con tact: 

Anne Jungell-Nortamo 




5): 90-95% 


95-100% 


NICOTINELL (antismoking prod uct) 

VOLTAREN CON SUMER (antirheumatic top i cal) 

STREPSILS (throat prep a ra tion) 


LAMISIL CON SUMER (dermatological antifungal) 






dermatological antifungals 10% 



gels/sols 26% 

liq uids 16% 


creams 6% 

SANDOZ 

Full Name: Sandoz Oy Ab 

Street Ad dress: Rajatorpantie 41 B, FIN-01640 

Vantaa 

Tel: +358 9 8520 2030 

Fax: +358 9 8520 2034 


De scrip tion: Pro moter, sales/detailer. Prod uct 



tion), hos pi tal pharmaceuticals, bi o log i cal prod - 

ucts, bio tech nol ogy prod ucts, med i cal equip ment, 

med i cal sup plies. Es tab lished 2005. 21 phar ma - 



ber): 12 (2008) 

Con tacts (Pharm): Chair man: Bo Skauen; 

Com mer cial Op er a tions: Karoliina 

Kaijasilta-jarvenpaa; Gen eral Con tact: Anne 

Manninen 




5): 75-80% 


95-100% 


RISPERIDON SANDOZ (antipsychotic) 

CEFUROXIM SANDOZ (cephalosporin) 

ROXITHROMYCIN SAND (macrolide/sim i lar type) 

CEFTRIAXON SANDOZ (cephalosporin) 

SUMATRIPTAN SANDOZ (antimigraine prep a ra - 

tion) 









vi als 21% 

tab lets 16% 

cap sules 13% 


FRANCE 

CIBA VI SION 

Full Name: CIBA Vi sion France S.A.S 

Street Ad dress: Immeuble Platon, Les 

Algorithmes, 17, av e nue Didier Daurat, 31 700 

Blagnac 

Tel: +33 5 34 61 69 00 

Fax: +33 5 34 61 69 89 

De scrip tion: Pro moter, sales/detailer, dis trib u - 

tor. Prod uct ranges in clude: phar ma ceu ti cal prod - 

ucts (branded, pre scrip tion), op ti cal instruments. 


G-GAM 

Full Name: Laboratoires GGAM 

Street Ad dress: Europarc, 33 rue Auguste 

Perret, 94 042 Creteil Cedex 

Tel: +33 1 43 99 47 31 

Fax: +33 1 43 99 06 78 

Email: g-gam@wanadoo.fr 

Home Page: www.g-gam.com 


sales/detailer. Man u fac tures for other com pa nies. 

Prod uct ranges in clude: phar ma ceu ti cal prod ucts, 

hos pi tal pharmaceuticals. Di vi sions in clude: 

Hospital; Retail. 



Con tacts (Pharm): Chair man: Philippe 

Besnard; Com mer cial Op er a tions: Karl Parance; 

Re search & De vel op ment: Pascal Albert 

Sub sid iary of: Sandoz, Ger many (100%) 

NOVARTIS 

Full Name: Novartis Pharma S.A.S. 

Postal Ad dress: BP 356, 92 506 

Rueil-Malmaison Cedex 

Street Ad dress: 2 et 4 rue Lionel Terray, 92 506 


Tel: +33 1 55 47 60 00 

Fax: +33 1 55 47 60 50 

Home Page: www.novartis.fr 


tor, packager/as sem bler, im porter, ex porter, for - 

mu la tor, dis trib u tor, pro moter, sales/detailer. 

De vel ops, man u fac tures, pro motes for other 




thal mic prod ucts, bi o log i cal prod ucts, bio tech nol - 

ogy prod ucts. Es tab lished 1997. 2002 


clude: Novartis Oncologie; Novartis Immunologie 

& Transplantation; Novartis Ophthalmics; General 

Medicine. 


ber): 501-1,000 (2007) 

Con tacts (Pharm): Chair man: Jean Christphe 

Tellier; Man u fac ture: Serge Runser; Re search & 

De vel op ment: Pat rick Trunet; Gen eral Con tact: 

Hugues Joublin 


Phar ma ceu ti cal Sales: US$ 1,600-1,700 mil - 

lion 



5): 60-65% 


90-95% 




uct) 


tion) 











vi als 18% 

cap sules 18% 

tab lets 6% 



Full Name: Novartis Sante Familiale S.A.S. 

Postal Ad dress: BP 440, 92 845 


Street Ad dress: 14, Bou le vard Richelieu, 92 500 


Tel: +33 1 55 47 80 00 

Fax: +33 1 55 47 80 20 

Home Page: www.novartis.fr 



ex porter, dis trib u tor, pro moter, sales/detailer. 

Pro motes for other com pa nies. Prod uct ranges in - 

clude: phar ma ceu ti cal prod ucts (branded, pre - 



Con tacts (Pharm): Chair man: San ti ago Teruel; 

Com mer cial Op er a tions: Marc Thibiant; Man u fac - 

ture: Nicolas Manceau; Mar ket Re search: Bruno 

Geffroy; Re search & De vel op ment: Jacques 

Uhlrich; Gen eral Con tact: Marc Thibiant 





5): 85-90% 


80-85% 


VOLTARENE EMULGEL (antirheumatic top i cal) 

NICOTINELL TTS (antismoking prod uct) 

ZYMADUO (vi ta min A/D plain/com bi na tion) 

IMPORTAL (lax a tive) 

LAMISIL CREME (dermatological antifungal) 




vi ta mins 11% 







liq uids 17% 

gels/sols 17% 


creams 9% 

SANDOZ 

Full Name: Sandoz S.A.S. 

Street Ad dress: 49, av e nue Geor ges Pompidou, 

92 593 Levallois Perret Cedex 

Tel: +33 1 49 64 48 00 

Fax: +33 1 49 64 48 48 

Home Page: www.sandoz.fr 

De scrip tion: De vel oper, for mu la tor, im porter, 

ex porter, pro moter, sales/detailer. De vel ops for 




pharmaceuticals, bio tech nol ogy prod ucts. Es tab - 


2007. 

Con tacts (Pharm): Chair man: Ma rie-Josephe 

Baud 





5): 50-55% 


90-95% 


OMEPRAZOLE SANDOZ (antiulcerant) 

VANCOMYCINE SANDOZ (an ti bac te rial other) 

SIMVASTATINE SANDO (cho les terol/triglyceride 


AMOXI AC CLAV SAND (pen i cil lin broad spec trum) 

PRAVASTATINE SANDO (cho les terol/triglyceride 





10% 






tab lets 26% 

cap sules 21% 


liq uids 4% 

GERMANY 

1A PHARMA 

Full Name: 1 A Pharma GmbH 

Street Ad dress: Keltenring 1 + 3, D-82041 

Oberhaching 

Tel: +49 6138825-0 

Fax: +49 6138825-25 

Email: info@1apharma.de 

Home Page: www.1apharma.de 





5): 50-55% 


95-100% 


OMEPRAZOL-1A PHARM (antiulcerant) 

FENTANYL-1AP.BET.M (an al ge sic nar cotic) 

IBU 1A PHARMA (antirheumatic non-steroidal; 

an al ge sic non-nar cotic) 

SIMVASTATIN-1A PH. (cho les terol/triglyceride 


METOPR.SUCCIN.1APH (beta-blocker agent 

plain) 






di uret ics 7% 


tab lets 42% 


cap sules 17% 


liq uids 4% 

CIBA VI SION 

Full Name: Ciba Vi sion Vertriebs GmbH 

Postal Ad dress: Postfach 10 02 24, D-63702 

Aschaffenburg 

Street Ad dress: Bauhofstrasse 16, D-63762 

Grossostheim 

Tel: +49 6026 941-0 

Fax: +49 6026 941-393 

Email: info@cibavision.de 

Home Page: www.cibavision.de 


ranges in clude: oph thal mic prod ucts. 124 phar - 

ma ceu ti cal em ploy ees in 2005. 




ber): 21-50 (2005) 

Con tacts (Pharm): Chair man: Francesco 

Balestrieri; Gen eral Con tact: F. Balestrieri 


HEXAL 

Full Name: Hexal Aktiengesellschaft 

Postal Ad dress: Postfach 12 63, D-83602 

Holzkirchen 

Street Ad dress: Industriestr. 25, D-83607 

Holzkirchen 

Tel: +49 8024 908 1127 

Fax: +49 8024 908 1242 

Email: ser vice@hexal.de 

Home Page: www.hexal.de 

De scrip tion: Prod uct ranges in clude: phar ma - 

ceu ti cal prod ucts. 

Con tacts (Pharm): Chair man: Hubert Mayr; 

Com mer cial Op er a tions: Beate Bauer, Helmut 

Plutat 


HEXAL GENTECH 

Full Name: HEXAL Gentech Forschungs GmbH 

Street Ad dress: Industriestrasse 25, D-83607 

Holzkirchen 

Tel: +49 8024 9080 

Fax: +49 8024 9081290 

Email: info@greinerbioone.com 

Home Page: www.hexal-gentech.de 


NOVARTIS 

Full Name: Novartis Pharma GmbH 

Postal Ad dress: Postfach, D-90327 Nuernberg 

Street Ad dress: Roonstrasse 25, D-90429 

Nuernberg 

Tel: +49 911 273-0 

Fax: +49 911 273-12653 

Home Page: www.novartispharma.de 

De scrip tion: Re searcher, de vel oper, dis trib u tor, 


phar ma ceu ti cal prod ucts (branded, pre scrip tion, 


thal mic prod ucts. Es tab lished 1997. 1,500 phar - 

ma ceu ti cal em ploy ees in 2005. Di vi sions include: 

Novartis Vaccines. 


ber): 501-1,000 (2005) 

Con tacts (Pharm): Chair man: Em man uel 

Pugimier; Com mer cial Op er a tions: Thomas 

Kordick; Man u fac ture: John Man ning; Mar ket Re - 

search: Roland Suess; Re search & De vel op ment: 

Dr H. Wolf; Gen eral Con tact: Roland Suess 



lion 



5): 60-65% 


85-90% 




uct) 

CODIOVAN (an gio ten sin-II an tag o nist com bi na - 

tion) 


MONO EMBOLEX (hep a rin) 









vi als 17% 

cap sules 10% 


tab lets 7% 


Full Name: Novartis Con sumer Health GmbH 

Street Ad dress: Zielstattstrasse 40, D-81379 

Muenchen 

Tel: +49 89 78 77-0 

Fax: +49 89 78 77-444 

Email: info.muenchen@novartis.com 

Home Page: www.novartis.de 


sales/detailer. Dis trib utes, pro motes, sells/de tails 


phar ma ceu ti cal prod ucts (branded, non-pre scrip - 

tion). Es tab lished 1997. 244 phar ma ceu ti cal 



ber): 51-100 (2007) 

Con tacts (Pharm): Chair man: Ed ward Vlacich; 

Mar ket Re search: Michaela Haertl 







5): 60-65% 


85-90% 


VOLTAREN NV- (antirheumatic top i cal; an al ge sic 

non-nar cotic) 

FENISTIL (antipruritic; an ti his ta mine sys temic) 

OTRIVEN (NVR) (na sal prep a ra tion top i cal) 

LAMISIL NV- (dermatological antifungal) 






antipruritics 6% 



gels/sols 40% 

liq uids 16% 


creams 9% 


SALUTAS 

Full Name: SALUTAS Pharma GmbH 

Street Ad dress: Otto-von-Guericke Allee 1, 

D-39179 Barleben 

Tel: +49 392 03 710 

Fax: +49 392 03 71-77 70 

Home Page: www.salutas.de 

De scrip tion: Man u fac turer, de vel oper, ex porter, 

dis trib u tor, pro moter. Prod uct ranges in clude: 


hos pi tal pharmaceuticals, in ter me di ates. 


Con tacts (Pharm): Com mer cial Op er a tions: Ms 

Schlosner; Re search & De vel op ment: Dr 

Hans-Joachim Runge 

Par ent of: Hexal, In do ne sia (6%). 

Sub sid iary of: Novartis, Swit zer land 

SANDOZ 

Full Name: Sandoz In ter na tional GmbH 

Street Ad dress: Industriestrasse 25, D-83607 

Holzkirchen 

Tel: +49 8024 908-0 

Fax: +49 8024 908-1290 

Email: info.sandoz@sandoz.com 

Home Page: www.sandoz.de 




De vel ops, man u fac tures, dis trib utes, ex ports, 

pro motes, sells/de tails for other com pa nies. Prod - 

uct ranges in clude: phar ma ceu ti cal prod ucts 


tion), hos pi tal pharmaceuticals, fine chem i cals, 

raw ma te ri als, bi o log i cal prod ucts, bio tech nol ogy 

prod ucts, di ag nos tic prod ucts, di etetic/nu tri tional 

prod ucts, herbal prod ucts, oph thal mic products, 

veterinary pharmaceuticals. Established 1986. 

Con tacts (Pharm): Chair man: Dr Andreas 

Struengmann, Dr Thomas Struengmann; Com - 

mer cial Op er a tions: Mr Mayr; Man u fac ture: Dr K. 

Klokkers; Mar ket Re search: Mr Spaeth; Re search 

& De vel op ment: Dr Andreas Struengmann, Dr P. 

Schoetter, Dr Schaefer; Gen eral Con tact: Dr 

Andreas Struengmann, Dr Thomas Struengmann 

Par ent of: Hexal, China (joint); G-Gam, France 

(100%); Novexal, Greece; Hexal, In do ne sia 

(94%); Rowex, Ire land (joint); Hexal, Rus sia 

(100%); Hexal, South Af rica (100%); Bexal, 

Spain; Ilsan Ilac, Tur key (100%). 



lion 



5): 40-45% 


90-95% 


OMEP (antiulcerant) 



FENTANYL-HEX.BET.M (an al ge sic nar cotic; an es - 

thetic gen eral) 

METOHEXAL SUCC (beta-blocker agent plain) 

GINGIUM (ce re bral/pe riph eral vasotherapeutic) 








tab lets 37% 


cap sules 16% 


liq uids 3% 

SANDOZ PHARMA 

Full Name: Sandoz Pharmaceuticals GmbH 



Street Ad dress: Carl Zeiss-Ring 3, D-85737 

Ismaning 

Tel: +49 89 244040 

Fax: +49 89 24404100 

Email: info@sandoz.de 

Home Page: www.sandoz.de 



unbranded, pre scrip tion, non-pre scrip tion), bi o - 

log i cal prod ucts. Es tab lished 2004. 230 phar ma - 



ber): 165 (2007) 

Con tacts (Pharm): Chair man: Hakka Taissel; 

Com mer cial Op er a tions: Stefan Uab, Dominik 

Vauhage; Mar ket Re search: Marco Wolf 





5): 45-50% 


90-95% 



FENTAN.SAND. BET.M (an al ge sic nar cotic) 

SIMVASTATIN SANDOZ (cho les terol/triglyceride 


CAL CIUM D SANDOZ (cal cium prod uct) 

METO-SUCCINAT SDZ (beta-blocker agent plain) 


min eral sup ple ments 12% 






tab lets 44% 


cap sules 15% 


pre-filled sy ringes/pens 4% 

GREECE 

NOVARTIS 

Full Name: Novartis (Hel las) SACI 

Postal Ad dress: PO Box 52001, Meta mor pho sis, 

GR-144 10 Ath ens 

Street Ad dress: Na tional Road No 1 (12th km), 

Meta mor pho sis, GR-144 51 Ath ens 

Tel: +30 21 0281 1712 

Fax: +30 21 0281 2014 

Home Page: www.novartis.gr 





non-pre scrip tion), hos pi tal pharmaceuticals, di - 

etetic/nu tri tional prod ucts, oph thal mic prod ucts. 



Health. Pharmaceuticals; Consumer Health; 

Health Nutrition. 


ber): 222 (2005) 

Con tacts (Pharm): Chair man: A. Wyss; Com - 

mer cial Op er a tions: S. Varthalis; Man u fac ture: E. 

Theodoridou; Mar ket Re search: A. Papachatzis; 

Re search & De vel op ment: P. Pontikis; Gen eral 

Con tact: P. Giachni 

Par ent of: Famar, Greece (3%). 





5): 60-65% 


90-95% 



CO DIOVAN (an gio ten sin-II an tag o nist com bi na - 

tion) 



EXJADE (iron-che lat ing agent) 









cap sules 24% 

liq uids 11% 

tab lets 9% 



Street Ad dress: 30 Vasileos Georgiou and 

Mikras Asias, GR-152 33 Halandri 

Tel: +30 210 689 23 19 

Fax: +30 210 689 26 55 



De scrip tion: Dis trib u tor, pro moter. Prod uct 

ranges in clude: phar ma ceu ti cal products. 

NOVEXAL 

Full Name: NOVEXAL Ellas Ltd. 

Street Ad dress: Ag. Dimitrou 25, GR-174 55 

Alimos 

Tel: +30 10 9828 876 

Fax: +30 10 9827 211 

Email: novexal@otenet.gr 


Con tacts (Pharm): Chair man: Thalia Koukidou; 

Gen eral Con tact: Thalia Koukidou 

Sub sid iary of: Sandoz, Ger many 

GUATEMALA 

NOVARTIS 

Full Name: Novartis Farmaceutica SA (ACC), 

Cen tral Amer ica & The Ca rib bean 

Postal Ad dress: Apartado Postal 1115, 01011 

Gua te mala City 

Street Ad dress: Anillo Periferico 30-31, Zona 11, 

01011 Gua te mala City 

Tel: +502 242-28-400 

Fax: +502 242-28-401 





scrip tion, non-pre scrip tion), oph thal mic prod ucts, 


250 phar ma ceu ti cal em ploy ees in 2006. Di vi sions 

in clude: An i mal Health; Con sumer Health; 

Pharma; Oncology; Ophthalmics; Transplant. 


ber): 101-500 (2006) 

Con tacts (Pharm): Chair man: Pi erre Werren; 

Com mer cial Op er a tions: Luis Roberto Torres; 

Mar ket Re search: Marco An to nio Mar ti nez; Gen - 

eral Con tact: Marco An to nio Martinez 




5): 80-85% 


95-100% 




tion) 


PANTECTA (antiulcerant) 










tab lets 19% 

cap sules 12% 

liq uids 9% 

am poules 5% 

HONDURAS 


Street Ad dress: Colonia Alameda, Casa No 

1104, Tegu ci gal pa 

Tel: +504 232-7337 

Fax: +504 232-4886 




5): 80-85% 


80-85% 


ESPASMO CANULASE (di ges tive in clud ing en - 

zymes) 


LAMISIL TOPIC (dermatological antifungal) 

MEBOCAINA WT (throat prep a ra tion) 

MEBOCAINA (throat prep a ra tion) 


di ges tives in clud ing di ges tive en zymes 20% 






tab lets 26% 

gels/sols 18% 


liq uids 14% 

creams 10% 



HONG KONG 

NOVARTIS 

Full Name: Novartis Pharmaceuticals (HK) Ltd 

Street Ad dress: Room 3703-4 Wind sor House, 

311 Glou ces ter Rd, Cause way Bay 

Tel: +852 2882 5222 

Fax: +852 2577 8003 

Email: info.hk@pharma.novartis.com 

Home Page: www.hk.novartis.com 




non-pre scrip tion), bio tech nol ogy prod ucts, di - 

etetic/nu tri tional prod ucts, oph thal mic prod ucts, 

vet er i nary pharmaceuticals. Es tab lished 1997. 80 


include: Novartis Consumer Health. 


ber): 21-50 (2007) 

Con tacts (Pharm): Chair man: James Hsiao; 

Gen eral Con tact: James Hsiao 





5): 60-65% 


85-90% 




agent) 




tion) 








cap sules 38% 


tab lets 11% 

vi als 7% 


HUNGARY 

NOVARTIS 

Full Name: Novartis Hun gary Healthcare LLC 

Postal Ad dress: H-1537 Bu da pest, PO Box 

453/80 

Street Ad dress: H-1114 Bu da pest, Bartok Haz, 

Bartok Bela ut 43-47 

Tel: +36 1 457-6500 

Fax: +36 1 457-6600 

Home Page: www.novartis.hu 

De scrip tion: Di vi sions in clude: Novartis Sandoz. 

Con tacts (Pharm): Chair man: Altan 

Demirdere; Com mer cial Op er a tions: Beata 

Bordas 





5): 55-60% 


90-95% 




tion) 



a ra tion) 










tab lets 9% 



cap sules 5% 


Full Name: Novartis Hun gary Healthcare LLC 

Postal Ad dress: H-1525 Bu da pest, PO Box 118 

Street Ad dress: H-1114 Bu da pest, Bartok Haz, 

Bartok Bela ut 43-47 

Tel: +36 1 457-6656 

Fax: +36 1 457-6647 

Home Page: www.novartis.hu 



Con tacts (Pharm): Com mer cial Op er a tions: 

Endre Nemeth (Sales), Laszlo Madarasz (Mar ket - 

ing); Gen eral Con tact: Laszlo Madarasz 




5): 75-80% 


80-85% 


NEOCITRAN (cold prep a ra tion with out anti-in fec - 

tive) 





MEBUCAIN (throat prep a ra tion) 




13% 






gels/sols 19% 

liq uids 14% 

tab lets 12% 


SANDOZ 

Full Name: Sandoz Hun gary L.L.C. 

Street Ad dress: H-1034 Bu da pest, Timar ut. 20. 

Tel: +36 1 430-2890 

Fax: +36 1 430-2899 

Home Page: www.sandoz.hu 





5): 45-50% 


90-95% 


OMEPRAZOL HEXAL (antiulcerant) 



CAL CIUM-SANDOZ (cal cium prod uct) 











tab lets 25% 

cap sules 22% 


liq uids 3% 

INDIA 

CHIRON 

Full Name: Chiron Behring Vac cines Pri vate Lim - 

ited 

Street Ad dress: 501 Shree Amba Shanti Cham - 

bers, Andheri Kurla Road, (opp. The Leela), 

Andheri East 400059, Mumbai 

Tel: +91 22 56930812/0810 

Fax: +91 22 56930813 


Home Page: www.novartis.co.in 

CHIRON BEHRING VAC CINES 

Full Name: Chiron Behring Vac cines Pri vate Ltd 

Street Ad dress: 501 Shree Amba Shanti Cham - 

bers, Maharashtra 


NOVARTIS 

Full Name: Novartis In dia Lim ited 

Street Ad dress: Royal In sur ance Build ing, 6th 

Floor, 14, J Tata Road, Mumbai 400020 

Tel: +91 22 22851111 

Fax: +91 22 22853720 






scrip tion), hos pi tal pharmaceuticals, in ter me di - 

ates, den tal prod ucts, di etetic/nu tri tional 

prod ucts, oph thal mic prod ucts. Es tab lished 1997. 

Di vi sions In clude: Pharma; Sandoz; Consumer 

Health; Animal Health. 

Con tacts (Pharm): Chair man: Ranjit Shahani; 

Com mer cial Op er a tions: Anit Matai, Yucal Sikri, 

K.N. Chandrasekaran; Mar ket Re search: Deep 

Ajmani; Gen eral Con tact: Deep Ajmani 







5): 75-80% 


90-95% 


VOVERAN (antirheumatic non-steroidal; 

antirheumatic top i cal; oph thal mic anti-in flam ma - 

tory non-steroidal) 

METHERGIN (la bor in ducer) 

TEGRITAL (antiepileptic) 


CAL CIUM SANDOZ (cal cium prod uct) 









tab lets 20% 

liq uids 18% 

am poules 18% 

gels/sols 5% 

SANDOZ 

Full Name: Sandoz Pri vate Ltd 

Street Ad dress: Plot Nos. D-31 & D-32, MIDC 

TTC In dus trial Area Turbhe, Turbhe, Navi Mumbai 

400705 

Tel: +91 22 55910485 

Fax: +91 22 55910472 






5): 85-90% 


95-100% 


REGESTRONE (pro ges to gen) 

PZA CIBA (antitubercular prod uct) 

RIMACTAZID (antitubercular prod uct) 

FORISTAL (an ti his ta mine sys temic) 



sex hor mones sys temic 29% 


antimycobacterials 24% 


antihypertensives 4% 


tab lets 56% 


vi als 10% 

liq uids 7% 

cap sules 3% 

INDONESIA 

CIBA VI SION 

Full Name: PT. CIBA Vi sion Batam 

Street Ad dress: Jalan Beringin Kav. 204, 

Batamindo In dus trial Park, Mukakuning, Batam 

29433 

Tel: +62 77 0611048 

Fax: +62 77 0611035 

Home Page: www.id.novartis.com 


HEXAL 

Full Name: PT Prima Hexal 

Street Ad dress: Wisma BSG, 5th floor, Jl.Ab dul 

Muis No.40, Ja karta-Pusat 10160 

Tel: +62 21 34834333 

Fax: +62 21 34834334 

Email: prod uct@primas-hexal.co.id 

Home Page: www.prima-hexal.co.id 


tor, packager/as sem bler, im porter, ex porter, pro - 

moter, sales/detailer. Man u fac tures, ex ports for 




pharmaceuticals, di ag nos tic prod ucts, di - 

etetic/nu tri tional prod ucts, herbal prod ucts. Es - 

tab lished 1999. 526 pharmaceutical employees in 

2005. 


ber): 281 (2005) 

Con tacts (Pharm): Chair man: Holger Guenzel; 

Com mer cial Op er a tions: Rohyat Indrawijaya; 

Man u fac ture: Jenny Timotiwu; Re search & De vel - 

op ment: Jin Nurhayati; Gen eral Con tact: Holger 

Guenzel 

Sub sid iary of: Sandoz, Ger many (94%) (group: 

Novartis, Swit zer land); Salutas, Ger many (6%) 

(group: Novartis, Swit zer land) 

NOVARTIS 

Full Name: PT. Novartis In do ne sia 



Postal Ad dress: PO Box 1076, Ja karta 10010 

Street Ad dress: 35th Floor WISMA 46 - KOTA 

BNI, Jl. Jenderal Sudirman Kav. 1, Ja karta 10220 

Tel: +62 21 2513251 

Fax: +62 21 2513252 



tor, packager/as sem bler, im porter, ex porter, pro - 

moter, sales/detailer. Man u fac tures for other 


cal prod ucts (branded, pre scrip tion, non-pre scrip - 

tion), hos pi tal pharmaceuticals, raw materials. 


Con tacts (Pharm): Chair man: Dr Wil liam 

Biantoro Wanandi; Com mer cial Op er a tions: Indra 

Santana; Man u fac ture: Indra Santana 





5): 50-55% 


85-90% 






SYNTOCINON (la bor in ducer) 









tab lets 32% 


cap sules 17% 

liq uids 11% 

am poules 8% 

SANDOZ 

Full Name: PT. Sandoz In do ne sia 

Street Ad dress: Menara Jamsostek, South 

Tower 24th Floor, Jl. Gatot Subroto No. 38, Ja - 

karta 12710 

Tel: +62 21 5290 1777 

Fax: +62 21 5290 1773 





5): 75-80% 


95-100% 



AMDIXAL (cal cium an tag o nist plain) 

RIMSTAR 4 FDC (antitubercular prod uct) 

TONAR (al i men tary tract/me tab o lism prod uct 

other) 

ATORSAN (cho les terol/triglyceride reg u lat ing 






10% 


al i men tary tract and me tab o lism prod ucts other 

7% 



tab lets 35% 

cap sules 15% 

liq uids 4% 

vi als 4% 

IRELAND 

NOVARTIS 

Full Name: Novartis Ire land Ltd 

Street Ad dress: Beech House, Beech Hill Of fice 

Cam pus, Clonskeagh, Dub lin 4 

Tel: +353 1 2601255 

Fax: +353 1 2601263 

Email: info.dub lin@pharma.novartis.com 

Home Page: www.ie.novartis.com 





ag nos tic prod ucts, bio tech nol ogy prod ucts, oph - 

thal mic prod ucts, op ti cal in stru ments, vet er i nary 

pharmaceuticals. Es tab lished 1997. Di vi sions 

include: Novartis Consumer Health. 


Klaus Ribbe; Man u fac ture: F. Sutter; Mar ket Re - 

search: L. Callaghan; Re search & De vel op ment: 

O. Ros 







5): 65-70% 


95-100% 





tion) 

FAMVIR (an ti vi ral non-HIV) 





antivirals sys temic 6% 





tab lets 14% 

cap sules 11% 

am poules 6% 


ROWEX 

Full Name: Rowex Ltd 

Street Ad dress: New town, Bantry Co Cork 

Tel: +353 27 50077/50149 

Fax: +353 27 50417 

Email: rowex@rowa-pharma.ie 

Home Page: www.rowa.ie 

De scrip tion: Packager/as sem bler, dis trib u tor, 

sales/detailer. Pro motes, sells/de tails for other 


cal prod ucts (branded, pre scrip tion), hos pi tal 

pharmaceuticals, herbal prod ucts. Established 

1993. 

Con tacts (Pharm): Chair man: Brigitte Wag - 

ner-Halswick; Com mer cial Op er a tions: Joe 

Keane; Gen eral Con tact: Joe Keane 

Sub sid iary of: Rowa, Ire land (50%); Sandoz, 

Ger many (joint) (group: Novartis, Swit zer land) 




5): 55-60% 


95-100% 


PRAVITIN (cho les terol/triglyceride reg u lat ing 


RAMILO (ACE in hib i tor plain) 

ATECOR (beta-blocker agent plain) 



CLOROM (macrolide/sim i lar type) 




14% 






tab lets 31% 

cap sules 14% 

gels/sols 1% 


ITALY 

CHIRON 

Full Name: Chiron S.r.l. 

Street Ad dress: Via Fiorentina 1, 53100 Siena 

Tel: +39 0577 243111 

Fax: +39 0577 243074 

Home Page: www.chiron.it 


turer, for mu la tor, packager/as sem bler, ex porter, 


ranges in clude: phar ma ceu ti cal prod ucts, bi o log i - 

cal prod ucts, bio tech nol ogy products. Established 

1992. 

CIBA VI SION 

Full Name: CIBA Vi sion S.r.l. 

Street Ad dress: Via Enrico Mattei 11, 30020 

Marcon/VE 

Tel: +39 041 5939400 

Fax: +39 041 4567981 



(branded, unbranded). 

Con tacts (Pharm): Chair man: Andrea 

Guimmole; Gen eral Con tact: Lugiana Fullin 


HEXAL 

Full Name: Hexal S.p.A. 

Street Ad dress: Largo Umberto Boccioni 1, 

21040 Origgio/VA 

Tel: +39 02 96541 



Fax: +39 02 96543496 

Home Page: www.sandoz.it 




5): 55-60% 


90-95% 


LANSOPRAZOLO HEX (antiulcerant) 

CARVEDILOLO HEX (beta-blocker agent plain) 

CEFTRIAXONE HEX (cephalosporin) 

SIMVASTATINA HEX (cho les terol/triglyceride reg - 

u lat ing prep a ra tion) 

GENTAM/BETAM HEX (corticosteroid top i cal com - 

bi na tion) 









tab lets 25% 

cap sules 24% 

liq uids 7% 

creams 5% 

MIPHARM 

Street Ad dress: Via Quaranta 12, 20141 Milano 

Tel: +39 2 535481 

Fax: +39 2 53548020 

Email: info@mipharm.it 

Home Page: www.mipharm.it 


tor, ex porter, packager/as sem bler, pro moter, 

sales/detailer. De vel ops, man u fac tures for other 


cal prod ucts (branded, pre scrip tion, non-pre scrip - 

tion), di etetic/nu tri tional prod ucts. Es tab lished 

1998. 200 pharmaceutical employees in 2008. 


ber): 51-100 (2008) 

Con tacts (Pharm): Chair man: Dr Giuseppe G. 

Miglio; Com mer cial Op er a tions: Dr Boselli Franco, 

Luca Testorelli; Man u fac ture: Luca Grisotti; Re - 

search & De vel op ment: Simonetta Alvino; Gen - 

eral Con tact: Giuseppe Miglio 

NOVARTIS 

Full Name: Novartis Farma SpA 

Postal Ad dress: Casella postale 88, 21047 

Saronno/VA 


21040 Origgio (VA) 

Tel: +39 02 96541 

Fax: +39 02 96542910 

Home Page: www.novartis.it 

Con tacts (Pharm): Chair man: Giacomo di Nepi 





5): 55-60% 


85-90% 




tion) 


agent) 










cap sules 38% 


tab lets 14% 


am poules 4% 


Full Name: Novartis Con sumer Health S.p.A. 

Postal Ad dress: Casella postale 155, 21047 

Saronno/VA 

Street Ad dress: Largo Umberto Boccioni, 1, 

21040 Origgio (VA) 

Tel: +39 02 964791 

Fax: +39 02 96479295 

Home Page: www.novartis.it 


packager/as sem bler, im porter, dis trib u tor, pro - 

moter, sales/detailer. Dis trib utes, sells/de tails for 


ma ceu ti cal prod ucts (branded, pre scrip tion, 


etetic/nu tri tional prod ucts. Es tab lished 1997. 156 




include: OTC (including dietetics). 


ber): 51-100 (2008) 

Con tacts (Pharm): Chair man: Teresio Roberto 

Bertani; Com mer cial Op er a tions: Massimo 

Micheli; Man u fac ture: An to nio Polastri 





5): 80-85% 


85-90% 



GAVISCON AD VANCE (ant acid/antiflatulent/car - 

mi na tive) 



PURSENNID (lax a tive) 

VOLTADOL (antirheumatic top i cal) 







10% 


liq uids 27% 

gels/sols 24% 


tab lets 11% 


NOVARTIS VAC CINES 

Street Ad dress: Bellaria Rosia, 53018 Sovicille 

Tel: +39 577 2436 19 

Fax: +39 577 2786 00 

Home Page: www.novartisvaccines.com 



95-100% 


5): n.a. 



MENJUGATE (vac cine pure) 

AGRIPPAL S1 (vac cine pure) 

FLUAD (vac cine pure) 

ANATETALL (vac cine pure) 

BIOCINE TEST PPD M (di ag nos tic test other) 


vac cines 97% 

di ag nos tic tests 3% 



vi als 30% 

am poules 13% 

liq uids 1% 

SANDOZ 

Full Name: Sandoz S.p.A. 


21040 Origgio/VA 

Tel: +39 02 96 541 

Fax: +39 02 96 543496 

Home Page: www.sandoz.it 


clude: phar ma ceu ti cal prod ucts (unbranded, pre - 

scrip tion), hos pi tal pharmaceuticals. 


ber): 101-500 (2007) 





5): 50-55% 


90-95% 


LANSOPRAZOLO SAN (antiulcerant) 

NICERGOLINA SAN (ce re bral/pe riph eral 

vasotherapeutic) 

AMOX+AC CLAV SAN (pen i cil lin broad spec trum) 


CEFTRIAXONE SAN (cephalosporin) 








tab lets 37% 

cap sules 19% 


liq uids 10% 

vi als 7% 



JAPAN 

CIBA VI SION 

Full Name: CIBA Vi sion K.K. 

Street Ad dress: Tennoz Cen tral Tower 13 F., 

2-2-24 Higashi-shinagawa, Shinagawa-ku, To kyo 

140-0002 

Tel: +81 3 5461 1301 

Fax: +81 3 5461 1396 

Home Page: www.cibavision.jp 


NOVARTIS 

Full Name: Novartis Pharma KK 

Street Ad dress: Nishi-Azabu Mitsui Bldg, 17-30 

Nishi-Azabu 4-chome, Minato-ku, To kyo 

106-8618 

Tel: +81 3 3797 8000 

Fax: +81 3 3797 4496 

Home Page: www.novartis.co.jp 



dis trib u tor, pro moter, sales/detailer. Man u fac - 

tures, dis trib utes, pro motes, sells/de tails for other 


cal prod ucts (branded, pre scrip tion), hos pi tal 

pharmaceuticals, di ag nos tic prod ucts, oph thal mic 

prod ucts. 3,500 pharmaceutical employees in 

2007. 


ber): 1,501-2,000 (2007) 

Con tacts (Pharm): Chair man: H. Mitani; Mar ket 

Re search: M. Saito; Gen eral Con tact: M. Saito 



lion 



5): 65-70% 


85-90% 







LAMISIL NOVARTIS (antifungal sys temic; 

dermatological antifungal) 









tab lets 9% 

cap sules 8% 



JORDAN 

NOVARTIS 


Postal Ad dress: PO Box 851698, Amman, 

11185 

Street Ad dress: Um Outhina, Shat Al-Arab 

Street, op po site to Red Rose ho tel, Mousa Nakho 

Build ing, Amman, 11110 

Tel: +962 6 5544101 

Fax: +962 6 5544406 


Con tacts (Pharm): Gen eral Con tact: Habib 

Ihsan 




5): 75-80% 


95-100% 



tion) 


a ra tion) 









10% 




tab lets 28% 

liq uids 19% 

cap sules 12% 

am poules 4% 



KAZAKHSTAN 

LEK 

Full Name: Lek Pharmaceuticals d.d., Rep re sen - 

ta tive Of fice Almaty 

Street Ad dress: 050051 Almaty, Luganskogo 

str. 54 Cot tage 9 

Tel: +7 3272 581 291 

Fax: +7 3272 506 463 

Email: lek@lek.kz 

De scrip tion: Rep re sen ta tive of fice. 38 phar ma - 

ceu ti cal em ploy ees in 2005. 


ber): 29 (2005) 

Con tacts (Pharm): Chair man: Dr Daniyar 

Segizbayer; Com mer cial Op er a tions: Dr Anar 

Dosmambetora; Mar ket Re search: Dr Anar 

Dosmambetora; Gen eral Con tact: Dr Daniyar 

Segizbayer 

NOVARTIS 

Full Name: Novartis Pharma Ser vices AG, Almaty 

Rep re sen ta tion Of fice Medeu re gion 

Street Ad dress: 050010 Almaty, pos. Koktube, 

Suyunbay str., h.34 

Tel: +7 3272 581 046 

Fax: +7 3272 581 048 


KENYA 

NOVARTIS 

Full Name: Novartis Pharma Ser vices AG, Rep.& 

Re gional Of fice East/Cen tral Af rica 

Postal Ad dress: PO Box 46057, Nai robi, 

00100-GPO 

Street Ad dress: Af rica Re Cen tre, 4th floor, Hos - 

pi tal Road, Up per Hill, Nai robi, 00100 

Tel: +254 20 2737771 

Fax: +254 20 2737775 





pharmaceuticals, herbal prod ucts, oph thal mic 

prod ucts. Established 1997. 

Con tacts (Pharm): Chair man: Dr Wellington 

Muiruri; Gen eral Con tact: Dr Wellington Muiruri 

LATVIA 

HEXAL 

Full Name: Hexal AG, Rep re sen ta tive Of fice Lat - 

via 

Street Ad dress: Meza iela 4, LV-1048 Riga 

Tel: +371 7 892 006 

Fax: +371 7 892 007 

Email: hexal@hexal.lv 

Home Page: www.hexal.lv 





5): 55-60% 


95-100% 






SIMVACOR (cho les terol/triglyceride reg u lat ing 


ACIC (vi ral in fec tion prod uct top i cal; an ti vi ral 

non-HIV) 





10% 




tab lets 54% 


gels/sols 7% 


creams 5% 

LEK 

Full Name: Lek Pharmaceuticals d.d. Rep re sen - 

ta tive Of fice Riga 

Street Ad dress: Rupniecibas 19-11, LV-1010 

Riga 

Tel: +371 7 326 210 

Fax: +371 7 326 040 




tion), hos pi tal pharmaceuticals. 

Con tacts (Pharm): Chair man: Normundos 

Pless 



Sub sid iary of: Sandoz, Aus tria 




5): 85-90% 


95-100% 


LINEX (antidiarrheal mi cro-or gan ism) 

AMOKSIKLAV 2X (pen i cil lin broad spec trum) 

BRONCHO MUNAL (vac cine other) 

FERRUM LEK (iron plain/com bi na tion) 

EDICIN (an ti bac te rial other) 





vac cines 8% 

antianemic prep a ra tions 8% 



cap sules 49% 

tab lets 23% 


liq uids 7% 


NOVARTIS 

Full Name: Novartis Pharma Ser vices AG, Rep re - 

sen ta tive & Re gional Of fice 

Street Ad dress: Brivibas gatve 214b, 302 kab., 

LV-1039 Riga 

Tel: +371 6 788 7070 

Fax: +371 6 788 7077 





5): 65-70% 


90-95% 







agent) 








tab lets 45% 


vi als 13% 

cap sules 11% 



Full Name: Novartis Con sumer Health Ser vices 

SA 

Street Ad dress: Kleistu 24, LV-1067 Riga 

Tel: +371 6 744 1300 

Fax: +371 6 744 1301 



(branded, non-pre scrip tion), med i cal equip ment. 

Es tab lished 1997. 7 phar ma ceu ti cal employees in 

2008. 


ber): 1-10 (2008) 

Con tacts (Pharm): Chair man: Bjarne 

Pedersen; Gen eral Con tact: Atvars Kurats 




5): 85-90% 


90-95% 


THERAFLU NON-DROWS (cold prep a ra tion with - 

out anti-in fec tive) 

TAVEGYL (an ti his ta mine sys temic) 

THERAFLU NIGHT TIM (cold prep a ra tion with out 

anti-in fec tive) 









9% 



liq uids 27% 

tab lets 13% 

gels/sols 10% 

creams 8% 



LEBANON 

NOVARTIS 

Full Name: Novartis Pharma Ser vices AG, Bei rut 

Rep re sen ta tive Of fice 

Postal Ad dress: PO Box 11-3448, Bei rut 

Street Ad dress: Weav ers Cen ter, 7th Floor, 

Clemenceau Street, Bei rut 

Tel: +961 1 363260 

Fax: +961 1 371567 





5): 60-65% 


90-95% 



tion) 



a ra tion) 






10% 






tab lets 31% 

cap sules 20% 

liq uids 10% 


SANDOZ 

Full Name: Sandoz GmbH, Bei rut Rep re sen ta tive 

Of fice 

Postal Ad dress: PO Box 90-1599, Bei rut 

Street Ad dress: Horsh Kfoury, Badaro, 

Noueihed Bldg. 6th floor, Bei rut 

Tel: +961 1 382 490 

Fax: +961 1 382 492 

Email: sandoz@sandoz-lb.com 

Home Page: sandoz-lb.com 



(branded, pre scrip tion, non-pre scrip tion). Es tab - 


2008. 


ber): 12 (2008) 

Con tacts (Pharm): Chair man: Abir Alaeddine; 

Com mer cial Op er a tions: Reina Tannous, Hisham 

Joudieh; Gen eral Con tact: Chantal Ghawi 




5): 95-100% 


95-100% 





BIODROXIL (cephalosporin) 

SUPPLIN (amebicide) 



antiparasitics 7% 


5% 





tab lets 30% 

liq uids 17% 

cap sules 12% 

oint ments 4% 

LITHUANIA 

HEXAL 

Full Name: Hexal AG, Co op er a tion Part ner/Rep - 

re sen ta tive Of fice Lith u a nia 

Street Ad dress: Zemaitijos g. 3-16, LT-01134 

Vilnius 

Tel: +370 52 61 31 06/30 63 

Fax: +370 52 61 30 66 

Email: hexal@takas.lt 

Home Page: www.hexal.lt 





med i cal equip ment, oph thal mic prod ucts. 


Con tacts (Pharm): Gen eral Con tact: Tauras 

Endriukaitis 






5): 55-60% 


90-95% 



MOXONIDIN HEXAL (antihypertensive non-herbal 

plain) 




non-HIV) 

RAMICOR (ACE in hib i tor plain) 








tab lets 46% 


cap sules 8% 


creams 4% 

LEK 

Full Name: Lek Pharmaceuticals d.d., Rep re sen - 

ta tive Of fice Vilnius 

Street Ad dress: Seimyniskiu g. 3A, LT-09312 

Vilnius 

Tel: +370 52 63 60 37 

Fax: +370 52 62 54 31 


Con tacts (Pharm): Chair man: Iztok Segula; 

Gen eral Con tact: Iztok Segula 

NOVARTIS 


sen ta tive Of fice 

Street Ad dress: Konstitucijos pr. 7, LT-09308 

Vilnius 

Tel: +370 52 69 16 50 

Fax: +370 52 49 63 38 




Es tab lished 1996. 24 phar ma ceu ti cal employees 

in 2008. 


ber): 11-20 (2008) 


Dovydas Snaideris; Mar ket Re search: Vita 

Kukiene; Gen eral Con tact: Kristina Zaveckiene 

Sub sid iary of: Novartis, Swit zer land 




5): 65-70% 


95-100% 




agent) 











tab lets 46% 

cap sules 24% 


vi als 7% 

creams 3% 



S.A. Rep re sen ta tive Of fice Lith u a nia 

Street Ad dress: Gostauto 40B, LT-01112 Vilnius 

Tel: +370 52 52 65 00 

Fax: +370 52 52 65 61 




5): 85-90% 


95-100% 


THERAFLU NON-DROWS (cold prep a ra tion with - 

out anti-in fec tive) 


THERAFLU NIGHT TIM (cold prep a ra tion with out 

anti-in fec tive) 


OTRIVIN MEN THOL (na sal prep a ra tion top i cal) 







7% 




liq uids 35% 


tab lets 12% 

gels/sols 11% 


SANDOZ 

Full Name: Sandoz Pharmaceuticals d.d., Rep re - 

sen ta tive Of fice Lith u a nia 

Street Ad dress: Seimyniskiu Str. 3A, LT-09312 

Vilnius 

Tel: +370 52 63 60 37 

Fax: +370 52 63 60 36 

Email: info.lith u a nia@gx.novartis.com 

Home Page: www.sandoz.lt 




tion), hos pi tal pharmaceuticals. 26 phar ma ceu ti - 

cal employees in 2005. 


ber): 17 (2005) 

Con tacts (Pharm): Mar ket Re search: Aurimas 

Sumskis; Gen eral Con tact: Evaldas Navickas 




5): 75-80% 


75-80% 



BANEOCIN (an ti bi otic/sulphonamide top i cal) 



KETONAL (antirheumatic non-steroidal; 





8% 







cap sules 18% 

vi als 11% 

tab lets 11% 

am poules 8% 

MACEDONIA 

NOVARTIS 



Street Ad dress: 1000 Skopje, ul. Pero Nakov 

b.b. 

Tel: +389 2 255 0151 

Fax: +389 2 255 0152 


MALAYSIA 

NOVARTIS 

Full Name: Novartis Cor po ra tion (Ma lay sia) Sdn. 

Bhd. 

Postal Ad dress: PO Box 1005, 46860 Petaling 

Jaya/Selangor Darul Ehs 

Street Ad dress: Level 15, The Crest, 3 Two 

Square, No.2, Jalan 19/1, 46300 Petaling 

Jaya/Selangor Darul Ehs 

Tel: +60 3 51926666 

Fax: +60 3 51916514 




in clude: phar ma ceu ti cal prod ucts (branded, 

unbranded, pre scrip tion, non-pre scrip tion). 






5): 65-70% 


90-95% 



tion) 




CAFERGOT (antimigraine prep a ra tion) 











tab lets 23% 

liq uids 10% 

cap sules 9% 

am poules 5% 

MEXICO 

GERBER 

Full Name: Productos Gerber, S.A. de C.V. 

Postal Ad dress: Apartado Postal 98, Queretaro, 

76000 

Street Ad dress: Epigmenio Gon za lez No.59, 

Colonia San Pablo, Queretaro, 76159 

Tel: +52 442 211 83 00 

Fax: +52 442 217 15 62 

HEXAL 

Full Name: Lab o ra to ries Hexal S.A. de C.V. 

Street Ad dress: Calle Candelaria 186, Colonia 

Atlantida, Delegacion Coyoacan, 04370 Mex ico 

DF 

Tel: +52 55 549 37 40 

Fax: +52 55 544 05 81 

Email: ser vice@hexal.com.mx 

Home Page: www.hexal.com.mx 

De scrip tion: Man u fac turer, dis trib u tor. Prod uct 

ranges in clude: phar ma ceu ti cal prod ucts. Es tab - 

lished 1998. 

Con tacts (Pharm): Chair man: Jorge Alberto 

Santos Quinonez 

NOVARTIS 

Full Name: Novartis Corporativo, S.A. de C.V. 

Street Ad dress: Calzada Tlalpan No. 1779, Col. 

San Diego Churubusco, Delegacion Coyoacan, 

Mex ico DF, 04120 

Tel: +52 55 542 087 00 

Fax: +52 55 554 417 20 

Email: con.tacto@pharma.novartis.com 

Home Page: www.novartis.com.mx 

De scrip tion: Dis trib utes, sells/de tails for other 

com pa nies. Es tab lished 1996. Di vi sions in clude: 

Novartis OTC. 

Con tacts (Pharm): Com mer cial Op er a tions: Dr 

Rolf Immler; Gen eral Con tact: Lic Je sus Origel 





5): 65-70% 


90-95% 



tion) 

VOLTAREN (antirheumatic non-steroidal; oph - 

thal mic anti-in flam ma tory non-steroidal) 


CATAFLAM (antirheumatic non-steroidal; 











tab lets 29% 

liq uids 10% 

cap sules 6% 

am poules 3% 

NOVARTIS GENERICS 

Full Name: Novartis Farmaceutica, S.A. de C.V. 

Street Ad dress: Augusto Ro din No.128, Col. San 

Juan Mixcoac, Delegacion Benito Juarez, Mex ico 

DF, 03730 

Tel: +52 55 548 23 400 

Fax: +52 55 561 53 797 

Home Page: www.novartis.com.mx 





5): 70-75% 


95-100% 


BENZETACIL AP (pen i cil lin me dium/nar row spec - 

trum) 

MEGION (cephalosporin) 

AVAPENA (an ti his ta mine sys temic) 

LOPRESOR (beta-blocker agent plain) 

AMLIBON (cal cium an tag o nist plain) 










vi als 32% 

tab lets 30% 


am poules 6% 

cap sules 6% 

MOROCCO 

NOVARTIS 

Full Name: Novartis Pharma Maroc SA 

Postal Ad dress: BP 7545, 20003 Ca sa blanca 

Street Ad dress: 82 blvd Chefchaouni, Quartier 

Industriel d’Ain Sebaa, 20250 Ca sa blanca 

Tel: +212 22 34 92 92 

Fax: +212 22 35 93 11 



sales/detailer. Man u fac tures, im ports, dis trib utes 




lished 1997. 158 pharmaceutical employees in 

2008. 


ber): 51-100 (2008) 

Con tacts (Pharm): Chair man: Roger Bassoul; 

Com mer cial Op er a tions: Annette Ake; Man u fac - 

ture: Mohsen Farouk; Mar ket Re search: Dr 

Ahmed Nour Elalaoui; Gen eral Con tact: Dr Ahmed 

Nour Elalaoui 





5): 80-85% 


95-100% 


VOLTARENE (antirheumatic non-steroidal) 




CO-TAREG (an gio ten sin-II an tag o nist com bi na - 

tion) 









tab lets 18% 


cap sules 4% 

am poules 4% 


Full Name: Novartis Pharma Maroc SA, Con - 

sumer Health 

Postal Ad dress: BP 7545, 20003 Ca sa blanca 

Street Ad dress: 82 blvd Chefchaouni, Quartier 

Industriel d’Ain Sebaa, 20250 Ca sa blanca 

Tel: +212 22 35 93 14 

Fax: +212 22 35 93 11 

NETHERLANDS 

CHIRON 

Postal Ad dress: Postbus 23023, 1100 DM Am - 

ster dam 

Street Ad dress: Hullenbergweg 83-85, 1101 CL 

Am ster dam 

Tel: +31 20 564 05 64 

Fax: +31 20 564 03 87 

HEXAL 

Full Name: Hexal B.V. 

Postal Ad dress: Postbus 251, 2180 AG Hillegom 

Street Ad dress: Pastoorslaan 28, 2180 BX 

Hillegom 

Tel: +31 252 53 23 66 

Fax: +31 252 52 39 93 

Email: sales@hexal.nl 

Home Page: www.hexal.nl 


tor, sales/detailer. Man u fac tures, im ports, dis trib - 

utes for other com pa nies. Prod uct ranges in clude: 

phar ma ceu ti cal prod ucts (non-pre scrip tion), hos - 

pi tal pharmaceuticals. Established 1996. 

Con tacts (Pharm): Chair man: Mar cel van 

Koningsbrugge; Com mer cial Op er a tions: N. 

Lampe; Mar ket Re search: N. Lampe; Gen eral 

Con tact: Mar cel van Koningsbrugge 

NOVARTIS 

Full Name: Novartis Pharma B.V. 

Postal Ad dress: Postbus 241, 6800 LZ Arnhem 

Street Ad dress: Raapopseweg 1, 6824 DP 

Arnhem 



Tel: +31 26 378 21 00 

Fax: +31 26 364 05 67 

Home Page: www.novartis.nl 

De scrip tion: De vel oper, im porter, pro moter, 

sales/detailer. Sells/de tails for other com pa nies. 



tal pharmaceuticals. Es tab lished 1997. 25 phar - 

ma ceu ti cal em ploy ees in 2005. Di vi sions include: 

Pharmaceutical; OTC. 


ber): 11-20 (2005) 





5): 70-75% 


90-95% 




SANDOSTATINE (hor mone hy po tha lamic) 


tion) 










vi als 10% 

cap sules 7% 


tab lets 6% 


Full Name: Novartis Con sumer Health B.V. 

Postal Ad dress: Postbus 2014, 4800 CA Breda 

Street Ad dress: Clau dius Prinsenlaan 142, 4818 

CP Breda 

Tel: +31 76 533 00 00 

Fax: +31 76 533 00 44 

Home Page: www.novartisconsumerhealth.nl 



(branded, pre scrip tion, non-pre scrip tion). 13 



ber): 3 (2007) 

Con tacts (Pharm): Chair man: Jalmar Wesslink; 

Com mer cial Op er a tions: Bas Vorste Veld; Mar ket 

Re search: Rieny Fokker; Gen eral Con tact: Rieny 

Fokker 


SANDOZ 

Postal Ad dress: Postbus 10332, 1301 AH 

Almere 

Street Ad dress: Veluwezoom 22, 1327 AH 

Almere 

Tel: +31 36 524 16 00 

Fax: +31 36 537 33 22 

Home Page: www.sandoz.nl 





unbranded, pre scrip tion, non-pre scrip tion), hos - 

pi tal pharmaceuticals. Es tab lished 1963. 57 phar - 

ma ceu ti cal employees in 2005. 


ber): 7 (2005) 

Con tacts (Pharm): Chair man: E. Gorka; Com - 

mer cial Op er a tions: H. Mol; Gen eral Con tact: 

Denise Heuberger 





5): 45-50% 


95-100% 


METOPROLOL-SDZ (beta-blocker agent plain) 

OMEPRAZOL-SDZ (antiulcerant) 

NIFEDIPINE-SDZ (cal cium an tag o nist plain) 

SIMVASTATINE-SDZ (cho les terol/triglyceride 


PRAVASTATIN.NA-SDZ (cho les terol/triglyceride 









tab lets 61% 




cap sules 12% 

liq uids 3% 


NEW ZEALAND 

CIBA VI SION 

Full Name: CIBA Vi sion Aus tra lia Pty Lim ited 

Street Ad dress: 6-8 MacKelvie Street, Grey 

Lynn 1002, Auckland 

Tel: +64 9 820-3728 

Fax: +64 9 820-3775 

Home Page: www.cibavision.com.au 

NOVARTIS 

Full Name: Novartis New Zea land Ltd 

Postal Ad dress: Pri vate Bag 47909, Ponsonby, 

1034 

Street Ad dress: 6-8 MacKelvie Street, Grey 

Lynn 1002, Auckland 

Tel: +64 9 361-8100 

Fax: +64 9 361-8181 

De scrip tion: Re searcher, im porter, ex porter, 




tal pharmaceuticals, di etetic/nu tri tional prod ucts, 

oph thal mic prod ucts, vet er i nary pharmaceuticals. 



Health. Pharmaceuticals; Con sumer Health; 

Animal Health; Ciba Vision New Zealand. 


ber): 11-20 (2008) 

Con tacts (Pharm): Chair man: Nuchanard 

Pinyapong; Mar ket Re search: Adam Gaskill; Gen - 

eral Con tact: Adam Gaskill 





5): 75-80% 


90-95% 



SANDIMMUN (immunosuppressive agent) 











cap sules 51% 

tab lets 17% 



am poules 3% 

NIGERIA 

NOVARTIS 


Postal Ad dress: PO Box 4310, Lagos 

Street Ad dress: 387 Agege Mo tor Road, Mushin, 

Lagos 

Tel: +234 1 4528535 

Fax: +234 1 4523500 


sales/detailer. De vel ops, pro motes, sells/de tails 


phar ma ceu ti cal prod ucts (pre scrip tion), oph thal - 

mic prod ucts. 25 phar ma ceu ti cal employees in 

2008. 


ber): 16 (2008) 

Con tacts (Pharm): Chair man: Chris Ufomadu; 

Com mer cial Op er a tions: Olusegun Omolambe 

NORWAY 

CIBA VI SION 

Full Name: Ciba Vi sion Norge A/S 

Postal Ad dress: Postboks 24, N-3602 

Kongsberg 

Street Ad dress: Dyrmyrgaten 47, N-3611 

Kongsberg 

Tel: +47 32 77 11 22 

Fax: +47 32 77 11 55 

Home Page: www.cibavision.no 




5): n.a. 



SPERSADEX M/KLORAM (ophthalmological 

anti-in flam ma tory/anti-in fec tive com bi na tion) 



SPERSALLERG (oc u lar anti-al ler gic/de con ges - 

tant/an ti sep tic) 

VISCOTEARS (ar ti fi cial tears/oc u lar lu bri cant) 

SPERSADEX (ophthalmological corticosteroid) 

OCULAC (ar ti fi cial tears/oc u lar lu bri cant) 




liq uids 73% 

gels/sols 16% 

vi als 9% 

oint ments 2% 

HEXAL 

Full Name: Hexal A/S 

Street Ad dress: Jernbaneveien 4, N-1400 Ski 

Tel: +47 64 91 30 00 

Fax: +47 64 85 09 30 

Email: post@hexal.no 

Home Page: www.hexal.no 

Con tacts (Pharm): Chair man: Bo Skauen; 

Com mer cial Op er a tions: Rolf Sveen; Gen eral 

Con tact: Tor Solheim 




5): 75-80% 


95-100% 


CLOZAPIN HEXAL (antipsychotic) 

CARVEDILOL HEXAL (beta-blocker agent plain) 

CIPROFLOXACIN HEX (fluoroquinolone) 

LORATADIN GEA (an ti his ta mine sys temic) 

CETIRIZIN HEXAL (an ti his ta mine sys temic) 








tab lets 71% 


cap sules 5% 

liq uids - 

creams - 

NOVARTIS 

Full Name: Novartis Norge AS 

Postal Ad dress: Postboks 237, N-0510 Oslo 

Street Ad dress: Brynsalleen 4, N-0667 Oslo 

Tel: +47 23 05 20 00 

Fax: +47 23 05 20 01 

Email: medisinsk.informasjon@novartis.com 

Home Page: www.novartis.no 

De scrip tion: Re searcher, pro moter, 



non-pre scrip tion), hos pi tal pharmaceuticals, vet - 

er i nary pharmaceuticals, oph thal mic prod ucts. 


in 2008. Di vi sions in clude: Sandoz (Generics); 

Pharma; OTC; Animal Health. 


ber): 21-50 (2008) 

Con tacts (Pharm): Chair man: Kees Roks; 

Com mer cial Op er a tions: Kees Roks; Mar ket Re - 

search: Petter Foss; Re search & De vel op ment: 

Tove Karlsrud 





5): 60-65% 


80-85% 




agent) 












tab lets 18% 

liq uids 18% 

cap sules 17% 

am poules 8% 

SANDOZ 

Full Name: Sandoz Pharma AS 

Street Ad dress: Jernbaneveien 4, N-1400 Ski 

Tel: +47 64 91 30 00 

Fax: +47 64 85 09 30 

Home Page: www.sandoz.no 






5): 90-95% 



METOPROLOL SANDOZ (beta-blocker agent 

plain) 

RISPERIDON SDZ (antipsychotic) 


PRAVASTATIN SANDOZ (cho les terol/triglyceride 


LORATADIN SANDOZ (an ti his ta mine sys temic) 








tab lets 83% 


cap sules - 

PAKISTAN 

NOVARTIS 

Full Name: Novartis Pharma Pa ki stan Ltd 

Street Ad dress: 15 West Wharf, Karachi 74000 

Tel: +92 21 2313386-90 

Fax: +92 21 2310072/2311009 







pharmaceuticals, bio tech nol ogy prod ucts, di - 

etetic/nu tri tional prod ucts, oph thal mic prod ucts. 


in 2007. Di vi sions in clude: Pharma; Consumer 

Health; Sandoz (Generic). 


ber): 230 (2007) 

Con tacts (Pharm): Chair man: Dr Farid Khan; 

Com mer cial Op er a tions: Farhaw Malik, M. Aslam, 

Shamsul Is lam, Sabir Khan Afridi, Rehmat Ullaha; 

Man u fac ture: Khalid Yousuf; Gen eral Con tact: Dr 

Farid Khan 





5): 55-60% 


95-100% 


VOLTRAL (antirheumatic non-steroidal) 

TEGRAL (antiepileptic) 

CAFLAM (antirheumatic non-steroidal) 

SYNTOCINON (la bor in ducer) 

MEPRESOR (beta-blocker agent plain) 





ap pe tite stim u lants 8% 



tab lets 38% 


am poules 11% 

liq uids 10% 

cap sules 8% 


Postal Ad dress: PO Box 100, Karachi 74000 

Street Ad dress: 15 West Wharf, Karachi 74000 

Tel: +92 21 2313386/87/88/89/90 

Fax: +92 21 2310027 

Home Page: www.pk.novartis.com 


porter, dis trib u tor, pro moter, sales/detailer. Prod - 


(branded, pre scrip tion). Es tab lished 2001. 280 



ber): 51-100 (2005) 

Con tacts (Pharm): Chair man: Malik 

Farhanbedar; Com mer cial Op er a tions: Naseer Zia 




5): 85-90% 


95-100% 


CAC 1000 (cal cium prod uct) 

SANCOS CO (antitussive) 

OPTALIDON (an al ge sic non-nar cotic) 

CAC 1000 PLUS (cal cium prod uct) 

TANDEGYL (an ti his ta mine sys temic) 








func tional gas tro-in tes ti nal dis or der drugs 4% 


tab lets 66% 

liq uids 24% 

am poules 5% 

gels/sols 3% 


PANAMA 

NOVARTIS 

Full Name: Novartis Pharma (Lo gis tics), Inc. 

Postal Ad dress: Apartado 0830-00659, Pan ama 

9 

Street Ad dress: Busi ness park, Torre Oeste 1 

Piso, Parque de Oficinas Costa del Este, Pan ama 

Tel: +507 301-44-84 

Fax: +507 300-23-85 

De scrip tion: Im porter, ex porter, pro moter, 



non-pre scrip tion). Es tab lished 1995. 

Con tacts (Pharm): Chair man: Diego Cuesta; 

Com mer cial Op er a tions: Marco Tay lor 


PERU 

CIFARMA 

Full Name: Cifarma S.A. 

Postal Ad dress: Apartado Postal 43-047, Lima 

Street Ad dress: Km 3.0 Carretera Cen tral 

No.1315, Santa Anita, Lima 43 

Tel: +51 1 618 62 00 

Fax: +51 1 628 62 01 

Email: cifarma@quimicasuiza.com 

Home Page: www.cifarma.com.pe 


tor, packager/as sem bler, im porter, ex porter. De - 

vel ops, for mu lates, man u fac tures, im ports, 

ex ports for other com pa nies. Prod uct ranges in - 


unbranded, pre scrip tion, non-pre scrip tion), di - 

etetic/nu tri tional prod ucts, raw ma te ri als, den tal 

prod ucts, herbal prod ucts, vet er i nary 

pharmaceuticals. Es tab lished 1992. 135 



ber): 0 (2008) 

Con tacts (Pharm): Chair man: Carlos 

Willstatter; Gen eral Con tact: Carlos Willstatter 

Sub sid iary of: Quimica Suiza, Peru (100%) 

NOVARTIS 

Full Name: Novartis Bio sci ences Peru SA 

Street Ad dress: Carretera Cen tral No. 1315, 

Km. 3.0, Santa Anita, Lima 43 

Tel: +51 1 494 27 88 

Fax: +51 1 494 26 73 

De scrip tion: Re searcher, packager/as sem bler, 

im porter, pro moter, sales/detailer. Pro motes, 



scrip tion, non-pre scrip tion), oph thal mic prod ucts. 



Health. Pharmaceuticals; Consumer Health. 


ber): 43 (2007) 

Con tacts (Pharm): Chair man: Jorge Contieras; 

Com mer cial Op er a tions: Carolina Lopez; Mar ket 

Re search: Fiorela Mansilla; Re search & De vel op - 

ment: Ricardo Avila 




5): 75-80% 


90-95% 


TONOPAN (antimigraine prep a ra tion) 



tion) 











tab lets 28% 

liq uids 10% 

am poules 8% 

cap sules 7% 



PHILIPPINES 

HEXAL 

Full Name: Hexal Phil ip pines, Inc. 

Street Ad dress: Unit 1105 Pearl Bank Cen tre, 

146 Valero St., Salcedo Vil lage, Makati City, Ma - 

nila 1227 

Tel: +63 2 840-04-11 

Fax: +63 2 830-22-52 

De scrip tion: Im porter, pro moter. Prod uct 


(branded, pre scrip tion). Es tab lished 2002. 89 

phar ma ceu ti cal em ploy ees in 2005. 


ber): 51-100 (2005) 

Con tacts (Pharm): Chair man: Allan Cruz 

NOVARTIS 

Full Name: Novartis Healthcare Phil ip pines, Inc. 

Postal Ad dress: PO Box 8721, Makati, 1200 

Street Ad dress: 5/F Asian Re in sur ance Bldg., 

Salcedo & Gamboa Streets, Legaspi Vil lage, 

Makati City, Ma nila 1229 

Tel: +63 2 815-93-71/815-93-85 

Fax: +63 2 816-41-91/816-64-39 


De scrip tion: Packager/as sem bler, im porter, 

pro moter, sales/detailer. Packs/as sem bles, im - 

ports, pro motes, sells/de tails for other com pa - 

nies. Prod uct ranges in clude: phar ma ceu ti cal 


tion), hos pi tal pharmaceuticals, oph thal mic prod - 

ucts. Es tab lished 1997. 500 phar ma ceu ti cal 

em ploy ees in 2007. Divisions include: Sandoz. 


ber): 101-500 (2007) 

Con tacts (Pharm): Chair man: Pe ter 

Goldschmidt; Com mer cial Op er a tions: Amal 

Kelshikar; Man u fac ture: An to nio Mar ti nez 

Marroquin; Mar ket Re search: Emmie Castillo; Re - 

search & De vel op ment: Fran cis Domingo; Gen - 

eral Con tact: Alicia Petines 





5): 55-60% 


90-95% 



tion) 

DIOVAN (an gio ten sin-II an tag o nist plain; an gio - 

ten sin-II an tag o nist com bi na tion) 

MOSEGOR VITA (ap pe tite stim u lant) 


RABIPUR (vac cine pure) 









tab lets 17% 

cap sules 16% 

liq uids 11% 

vi als 7% 

NOVARTIS AN I MAL HEALTH 

Full Name: Novartis Healthcare Phil ip pines, Inc. 

Street Ad dress: 3/F, Asian Re in sur ance Bldg., 

Salcedo & Gamboa Streets, Legaspi Vil lage, Ma - 

nila 

Tel: +63 2 815-93-71 

Fax: +63 2 810-40-16 

POLAND 

ALIMA-GERBER 

Full Name: Alima-Gerber S.A. 

Street Ad dress: ul. Cybernetyki 7, 02-677 War - 

saw 

Tel: +48 22 607 3030 

Email: kontakterber.pl 

Home Page: www.gerber.pl 

BIOCHEMIE 

Full Name: Biochemie Po land Sp. z o.o. 

Street Ad dress: ul. Piekna 13, Woj. 

Kujawsko-pomorskie, Pow. Bydgoski, 85-303 

Bydgoszcz 

Tel: +48 52 373 4218 

Fax: +48 52 373 4218 




5): n.a. 


95-100% 







BANEOCIN (an ti bi otic/sulphonamide top i cal) 

THIOPENTAL (an es thetic gen eral) 




13% 





liq uids 15% 

oint ments 13% 

vi als 13% 

cap sules 6% 

CIBA VI SION 

Street Ad dress: Bokserska 66, 02-690 Warsawa 

Tel: +48 22 455 7585 

Fax: +48 22 455 7580 

Email: info.cvplwa@cibavision.novartis.com 

Home Page: www.cibavision.pl 


clude: oph thal mic prod ucts. Es tab lished 1998. 

Sub sid iary of: Novartis, Po land (100%) 



95-100% 


5): n.a. 



VITREOLENT (anticataract prep a ra tion) 

MIOCHOL E (miotic/antiglaucoma prep a ra tion) 

VITACIC (ophthalmological other) 




liq uids 100% 

am poules - 

HEXAL 

Full Name: HEXAL POLSKA Sp. z.o.o. 

Street Ad dress: Ul. Domaniewska 50C, 02-672 

War saw 

Tel: +48 22 549 1500 

Fax: +48 22 549 1501 

Email: hexal@hexal.com.pl 

Home Page: www.hexal.com.pl 


tor, pro moter, sales/detailer. Prod uct ranges in - 



pharmaceuticals, oph thal mic prod ucts. 


Con tacts (Pharm): Chair man: Andrzej 

Trzeciakowski; Com mer cial Op er a tions: Er nest 

Bartosik; Man u fac ture: Krzysztof Jagielski; Re - 

search & De vel op ment: Dr Wojciech Nielubowicz; 

Gen eral Con tact: Anna Zych 




5): 75-80% 


95-100% 




PENTOHEXAL (ce re bral/pe riph eral 

vasotherapeutic) 

DICLAC (antirheumatic non-steroidal) 


LISIHEXAL (ACE in hib i tor plain) 




18% 





tab lets 66% 


am poules 4% 



LEK 

Full Name: Lek Polska Sp.z.o.o. 

Street Ad dress: ul. Podlipie 16, 95-010 Strykow 

Tel: +48 42 710 6100 

Fax: +48 42 710 6160 

Home Page: www.lek.com.pl 


tor, pro moter, sales/detailer. Im ports, dis trib utes, 




tal pharmaceuticals, herbal prod ucts, vet er i nary 


Con tacts (Pharm): Chair man: Marko Dolzan; 

Com mer cial Op er a tions: Ryszard Morawski; Man - 

u fac ture: Agnieszka Szworcer; Gen eral Con tact: 

Ryszard Morawski 







5): 60-65% 


85-90% 




ORTANOL (antiulcerant) 



ra tion) 







11% 




tab lets 20% 

cap sules 20% 

gels/sols 7% 

am poules 4% 

NOVARTIS 

Full Name: Novartis Po land Sp.z.o.o. 

Street Ad dress: Al. Witosa 31, 00-710 War saw 

Tel: +48 22 550 8888 

Fax: +48 22 550 8700 

Home Page: www.novartis.pl 

Con tacts (Pharm): Chair man: Jyrki Tapani Sura 

Par ent of: Ciba Vi sion, Po land (100%). 





5): 65-70% 


90-95% 







agent) 









cap sules 29% 

tab lets 14% 

vi als 8% 

liq uids 3% 


Full Name: Novartis Po land Sp. z o.o. 

Street Ad dress: ul. Bokserska 66, 02-690 War - 

saw 

Tel: +48 22 375 7575 

Fax: +48 22 375 7577 

Home Page: www.novartis.pl 




5): 75-80% 


80-85% 



VOLTAREN (antirheumatic top i cal) 



OROFAR (throat prep a ra tion) 

PROCTO GLYVENOL (antihemorrhoidal top i cal) 




18% 





liq uids 31% 

gels/sols 23% 

tab lets 13% 


creams 7% 

SANDOZ 

Full Name: Biochemie GmbH Oddzial w 

Warszawie 

Street Ad dress: ul.Marconich 9 m 6, 02-954 

War saw 

Tel: +48 22 642 5610/840 8276 

Fax: +48 22 642 1526 






5): 90-95% 



XORIMAX (cephalosporin) 

PIRAMIL (ACE in hib i tor plain) 

OMNITROPE (hor mone growth) 

SUMIGRA (antimigraine prep a ra tion) 

CILON (an ti de pres sant) 









tab lets 28% 

vi als 16% 

PORTUGAL 

BEXAL 

Full Name: Bexal-Produtos Farmaceuticos, S.A. 

Street Ad dress: Alameda da Beloura, Ed. EE1 - 

2.andar, Escritorio 15, Quinta da Beloura, 

P-2710-693 Sintra 

Tel: +351 21 924 19 11 

Fax: +351 21 924 98 04 



ceu ti cal products. 

Con tacts (Pharm): Chair man: Raul Oliveira; 

Com mer cial Op er a tions: Josue Cachulo; Gen eral 

Con tact: Ana Agostinho 

NOVARTIS 

Full Name: Novartis Farma - Produtos 

Farmaceuticos SA 

Postal Ad dress: Apartado 200, P-2711-901 

Sintra 

Street Ad dress: Rua do Centro Empresarial, Ed. 

8, Quinta da Beloura, P-2710-444 Sintra 

Tel: +351 21 000 86 00 

Fax: +351 21 000 86 06 




non-pre scrip tion), hos pi tal pharmaceuticals, bi o - 

log i cal prod ucts, bio tech nol ogy prod ucts, oph thal - 

mic prod ucts, vet er i nary pharmaceuticals. Es tab - 

lished 1997. Di vi sions in clude: Ciba Vi sion 

(ophtalmological products); Animal Health. 

Con tacts (Pharm): Chair man: Al ex an der 

Triebnigg; Com mer cial Op er a tions: Jose Al bu - 

quer que; Mar ket Re search: Maria E. Pinto; Re - 

search & De vel op ment: Rui Marques; Gen eral 

Con tact: Maria Joao Dias 





5): 70-75% 


95-100% 



tion) 




a ra tion) 






antiparkinson drugs 6% 




tab lets 19% 

cap sules 11% 

liq uids 3% 



Street Ad dress: Avenida Jose Malhoa No. 16B, 

1., 1.2, P-1099-092 Lisboa 

Tel: +351 21 781 10 00 

Fax: +351 21 781 10 80 

Email: nch.por tu gal@ch.novartis.com 





oph thal mic prod ucts. Es tab lished 1997. 68 phar - 



ber): 32 (2008) 

Con tacts (Pharm): Chair man: Maria Do Ceu 

Correia; Com mer cial Op er a tions: Faustino 



Moreira (Sales), Rosario Jorge (Mar ket ing); Man - 

u fac ture: Miguel Caldas (Lo gis tics); Mar ket Re - 

search: Rosario Jorge; Re search & De vel op ment: 

Rita Munes; Gen eral Con tact: Carlos Simoes 





5): 70-75% 


85-90% 




MEBOCAINA (throat prep a ra tion) 

FENISTIL (antipruritic) 

PURSENNIDE (lax a tive) 







6% 


gels/sols 48% 

liq uids 20% 



tab lets 4% 

SANDOZ 

Full Name: Sandoz Farmaceutica Lda. 

Street Ad dress: Alameda da Beloura, Edificio EE 

1, 2do andar - Escritorio 15, Quinta da Beloura, 

P-2710-444 Sintra 

Tel: +351 21 924 19 11 

Fax: +351 21 924 98 04 




5): 65-70% 


95-100% 


SINVASTATIN MG SDZ (cho les terol/triglyceride 


OMEPRAZOL MG SDZ (antiulcerant) 

CAL CIUM D SANDOZ (cal cium prod uct) 

AMOX.A.CLAV.MG SDZ (pen i cil lin broad spec - 

trum) 

SERTRALINA MG SDZ (an ti de pres sant) 



18% 







tab lets 28% 

cap sules 21% 

gels/sols 2% 


PUERTO RICO 

CIBA VI SION 

Full Name: CIBA Vi sion Puerto Rico, Inc. 

Postal Ad dress: PO Box 1360, Cidra, 00739 

Street Ad dress: El Jibaro In dus trial Park, Lots 

No. 1 & 2, Cidra, 00739 

Tel: +1 787 434-7200 

Fax: +1 787 739-1440 


GERBER 

Full Name: Gerber Prod ucts Com pany of Puerto 

Rico, Inc. 

Postal Ad dress: PO Box 1769, Carolina, 

00984-1769 

Street Ad dress: URB In dus trial Julio N. Matos, 

Carr 887, K.M.O., HM7, Lote 26, Carolina, 00987 

Tel: +1 787 769-7745 

Fax: +1 787 762-1945 

Home Page: www.novartisnutrition.com 

ROMANIA 

HEXAL 

Full Name: Hexal Ro ma nia s.r.l. 

Street Ad dress: Cal. Plevnei, No. 141, Bl. 3, Apt. 

33, Sec tor 6, 74325 Bu cha rest 

Tel: +40 21 315 15 00 

Fax: +40 21 316 37 03 


sales/detailer. Es tab lished 1998. 

Con tacts (Pharm): Chair man: Dr Dinu 

Stanculeanu 




5): 80-85% 




95-100% 


NICERIUM (ce re bral/pe riph eral vasotherapeutic) 

AMLOHEXAL (cal cium an tag o nist plain) 



ACC 200 (ex pec to rant) 








11% 



cap sules 39% 


tab lets 15% 

gels/sols 8% 

liq uids 4% 

LEK 

Full Name: Lek PharmaTech S.R.L., Targu-Mures 

Street Ad dress: Str. Livezeni nr. 7A, 540472 

Targu-Mures 

Tel: +40 26 520 81 23 

Fax: +40 26 520 47 67 


Con tacts (Pharm): Chair man: Tomislav Cuk; 

Gen eral Con tact: Tomislav Cuk 




5): 85-90% 


90-95% 




AMOKSIKLAV 2 (pen i cil lin broad spec trum) 

AXYCEF (cephalosporin) 

LEKOKLAR (macrolide/sim i lar type) 

AZITROMICINA (macrolide/sim i lar type) 








tab lets 39% 


liq uids 11% 

cap sules 10% 

gels/sols 4% 

NOVARTIS 



Street Ad dress: Bu cha rest Busi ness Park, en - 

trance B, parter (ground floor), 1A, Sos. Bucuresti 

- Ploiesti, 013681 Bu cha rest 

Tel: +40 21 312 99 01 

Fax: +40 21 312 99 07 




5): 70-75% 


95-100% 










antiparkinson drugs 11% 




cap sules 50% 



tab lets 8% 

am poules 3% 



SA, Rep re sen ta tive Of fice Ro ma nia 

Street Ad dress: 133-137 Calea Floreasca, 1st 

floor, sec tor 1, Bu cha rest 

Tel: +40 21 231 63 44 

Fax: +40 21 231 63 43 

PHARMATECH 

Full Name: Lek Pharmatech srl. 

Street Ad dress: Str. Argesului 25, 4300 Tirgu 

Mures 

Tel: +40 26 521 52 97 



Fax: +40 26 521 05 64 


bler, ex porter, pro moter, sales/detailer. De vel - 

ops, man u fac tures, im ports, ex ports, pro motes, 



unbranded, pre scrip tion). Established 2001. 

Con tacts (Pharm): Chair man: Tomislav Cuk; 

Com mer cial Op er a tions: Alexandru Dinu; Man u - 

fac ture: Bogdan Antonela; Gen eral Con tact: 

Tomislav Cuk 

Sub sid iary of: Lek, Slovenia (100%) 




5): n.a. 



AMOXICILLIN (pen i cil lin broad spec trum) 

CECLODYNE (cephalosporin) 

AMPICILLIN (pen i cil lin broad spec trum) 

CEXYL (cephalosporin) 

OXACILIN (pen i cil lin me dium/nar row spec trum) 




cap sules 65% 

liq uids 34% 


tab lets - 

RUSSIA 

CHIRON VAC CINES 

Street Ad dress: 119002 Mos cow, Glazovskiy 

lane, 7 of fice 9 

Tel: +7 495 933 5909 

Fax: +7 495 933 5903 


Home Page: www.novartis.ru 

HEXAL 

Full Name: Hexal AG 

Street Ad dress: 119002 Mos cow, B. 

Palashevskiy per., 15, str. 1,2 

Tel: +7 95 787 8590 

Fax: +7 95 787 8592 

Email: hexal@hexal.ru 




tion), hos pi tal pharmaceuticals, herbal prod ucts, 




ber): 70 (2006) 

Con tacts (Pharm): Chair man: Stefan Marks; 

Mar ket Re search: Olga Lvovna Levitskaya; Gen - 

eral Con tact: Ma rina Lushbina 





5): 85-90% 


90-95% 





AMBROHEXAL (ex pec to rant) 








4% 




tab lets 49% 


liq uids 8% 

gels/sols 6% 


LEK 

Full Name: Lek Pharmaceuticals d.d. 

Street Ad dress: 123104 Mos cow, Bolshoy 

Palashevskiy per, 15 

Tel: +7 95 258 8484 

Fax: +7 95 258 8485 


Con tacts (Pharm): Chair man: Metod Dragonja; 

Gen eral Con tact: Vladislav Veresov 





5): 70-75% 


90-95% 








PERSEN (hyp notic/sed a tive) 

IMMUNAL (ther a peu tic prod uct other) 







ther a peu tic prod ucts other 7% 


cap sules 42% 

tab lets 22% 


liq uids 10% 

am poules 6% 

NOVARTIS 

Full Name: ZAO Novartis En ter prise AG 

Street Ad dress: 123104 Mos cow, B. 

Palaschweskij Pereulok 15/A 

Tel: +7 95 967 1270 

Fax: +7 95 973 1268 

Email: pharma@novartis.ru 


De scrip tion: Rep re sen ta tive of fice. Re searcher, 



hos pi tal pharmaceuticals. Established 1997. 

Con tacts (Pharm): Chair man: Ger ald Schuh; 

Com mer cial Op er a tions: Anton Pronin, Natalia 

Lobodenko; Gen eral Con tact: Ger ald Schuh 





5): 50-55% 


85-90% 



ADELPHAN ESIDREX (antihypertensive 

non-herbal with di uretic) 



LAMISIL (antifungal sys temic) 








tab lets 31% 

cap sules 18% 

am poules 16% 


liq uids 11% 


Street Ad dress: 123317 Mos cow, 

Naberezhnaya Tower Busi ness Cen ter, 14th Floor, 

Krasnopresnenskaya nab., 18 

Tel: +7 95 969 2165 

Fax: +7 95 969 2166 






5): 85-90% 


95-100% 


TERAFLU (cold prep a ra tion with out anti-in fec tive) 


LAMISIL (dermatological antifungal) 

DLIANOS (na sal prep a ra tion top i cal) 

VOLTAREN (antirheumatic top i cal) 








liq uids 37% 


gels/sols 14% 

creams 9% 

tab lets 6% 

SAUDI ARABIA 

NOVARTIS 


Postal Ad dress: PO Box 16032, Ri yadh 11464 

Street Ad dress: Prince Mo ham med Bin 

Abdulaziz Street, Tahlia St, Suleymania, Ri yadh 

11464 



Tel: +966 1 465 8882 

Fax: +966 1 464 8127 




oph thal mic prod ucts. c.100 phar ma ceu ti cal em - 

ploy ees in 2008. Di vi sions in clude: Novartis Con - 

sumer Health. Pharma; Con sumer Health; 

Ophthalmic. 


ber): 101-500 (2008) 

Con tacts (Pharm): Chair man: Phil Rush; Com - 

mer cial Op er a tions: Mohamed Metwally; Mar ket 

Re search: Syed Mahmood Razvi; Gen eral Con - 

tact: Phil Rush 




5): 60-65% 


85-90% 




tion) 

MOSEGOR (ap pe tite stim u lant) 











tab lets 26% 

cap sules 13% 

liq uids 11% 

am poules 9% 

SERBIA 

NOVARTIS 

Full Name: Novartis Pharma Ser vices Inc. 

Street Ad dress: 11070 Bel grade, Bul. AVNOJ-a 

71/VI/18 

Tel: +381 11 313 1126 

Fax: +381 11 313 0164 





thal mic prod ucts. 18 phar ma ceu ti cal employees 

in 2007. 


ber): 10 (2007) 

Con tacts (Pharm): Chair man: Branislav 

Diordjevic 

SANDOZ 


Street Ad dress: 11000 Bel grade, Resavska 29 

Tel: +381 11 323 1275 




tion), hos pi tal pharmaceuticals. 

Con tacts (Pharm): Chair man: Ljubisa Kukuric; 

Gen eral Con tact: Ljubisa Kukuric 

SINGAPORE 

CIBA VI SION 

Full Name: CIBA Vi sion (Sin ga pore) Pte Ltd 

Street Ad dress: 491B River Val ley Road, 

03-02/03 Val ley Point, Sin ga pore 248373 

Tel: +65 6 7221288 

Fax: +65 6 7371937 



Full Name: Novartis Con sumer Health Sin ga pore 

P/L 

Street Ad dress: 491B River Val ley Road 13-02 

Val ley Point, Sin ga pore 248373 

Tel: +65 6 7370338 

Fax: +65 6 8380818 


NOVARTIS ITD 

Full Name: Novartis In sti tute for Trop i cal Dis - 

eases Pte Ltd 

Street Ad dress: 10 Biopolis Road, No. 05-01 

Chromos, Sin ga pore 138670 

Tel: +65 6 7222900 

Fax: +65 6 7222910 


NOVARTIS PHARMACEUTICALS 

Full Name: Novartis (Sin ga pore) Pte Ltd 

Street Ad dress: 10 Hoe Chiang Road, No. 

09-05/06 Kep pel Tow ers, Sin ga pore 089315 

Tel: +65 6 7226010 

Fax: +65 6 3234335 



De scrip tion: Re searcher, im porter, ex porter, 



non-pre scrip tion), hos pi tal pharmaceuticals, bi o - 

log i cal prod ucts, bio tech nol ogy prod ucts, oph thal - 

mic prod ucts. Es tab lished 1997. 53 


clude: Pharmaceuticals; Re gional Phar ma ceu ti cal 

Asia Pa cific Of fice; An i mal Health; Novartis In sti - 

tute for Trop i cal Dis eases; Con sumer Health; 

Medical Nutrition; Cibavision; Regional Auditing. 


ber): 11-20 (2006) 

Con tacts (Pharm): Chair man: Linda Seah; 

Com mer cial Op er a tions: Tan Siew Siew, Poh 

Hwee Tee 




5): 70-75% 


90-95% 



agent) 













cap sules 20% 


tab lets 12% 

liq uids 5% 

SANDOZ 

Street Ad dress: 5 Pereira Road No. 04-03, 

Asiawide In dus trial Build ing, Sin ga pore 368025 

Tel: +65 6 2848189 

Fax: +65 6 2802561 




5): 95-100% 


95-100% 



CEFAZOLIN (cephalosporin) 


PEN I CIL LIN G SOD (pen i cil lin me dium/nar row 

spec trum) 

LISDENE (ACE in hib i tor plain) 





2% 





vi als 12% 

cap sules 3% 

tab lets 3% 

liq uids 2% 

SLOVAK REPUBLIC 


Full Name: Novartis Con sumer Health Inc. 

Street Ad dress: Trencianska 47, 821 09 

Bratislava 2 

Tel: +421 2 5542 4931 

Fax: +421 2 5556 1386 




5): 70-75% 


85-90% 



THERAFLU (cold prep a ra tion with out anti-in fec - 

tive) 








15% 







liq uids 28% 

gels/sols 24% 


cap sules 10% 

creams 7% 

SANDOZ 

Full Name: Sandoz d.d., Rep re sen ta tive Of fice 

Street Ad dress: Ruzinovska 42, 821 03 

Bratislava 

Tel: +421 2 4820 0600 

Fax: +421 2 4820 0650 

Home Page: www.sandoz.sk 


Pro motes, sells/de tails for other com pa nies. Prod - 


(branded, pre scrip tion), hos pi tal 

pharmaceuticals, bio tech nol ogy prod ucts, herbal 

products. 

Con tacts (Pharm): Chair man: Chris tian Wieser; 

Gen eral Con tact: Chris tian Wieser 

Sub sid iary of: Lek, Slovenia 




5): 60-65% 


85-90% 




ra tion) 


EDICIN (an ti bac te rial other) 





11% 






tab lets 28% 

vi als 10% 

cap sules 9% 

liq uids 6% 

SLOVENIA 

LEK 

Full Name: Lek Pharmaceuticals d.d. 

Street Ad dress: 1526 Ljubljana, Verovskova 57 

Tel: +386 1 580 2111 

Fax: +386 1 568 3517 

Email: info@lek.si 

Home Page: www.lek.si/eng 


turer, im porter, ex porter, dis trib u tor, pro moter. 

Man u fac tures, dis trib utes for other com pa nies. 



tion), hos pi tal pharmaceuticals, fine chem i cals, 

in ter me di ates, raw ma te ri als, di ag nos tic prod - 

ucts, vet er i nary pharmaceuticals. Es tab lished 

1946. Di vi sions in clude: Pharmaceuticals; Ac tive 

Phar ma ceu ti cal Ingredients; OTC; Animal Health; 

Cosmetics; Medical. 

Con tacts (Pharm): Chair man: Janja Bratos; 

Man u fac ture: Bojan Dolenc; Mar ket Re search: 

Bojan Videtic; Gen eral Con tact: Ales Koce 

Par ent of: Lek, Mac e do nia; Pharmatech, Ro ma - 

nia (100%); Sandoz, Slo vak Re pub lic; 

Sanofi-Synthelabo Lek, Slovenia (49%). 





5): 60-65% 


85-90% 



ra tion) 

LEKADOL (an al ge sic non-nar cotic) 

OLIVIN (ACE in hib i tor plain) 

ORTANOL (antiulcerant) 

AMOKSIKLAV 2 (pen i cil lin broad spec trum) 




12% 





tab lets 46% 


cap sules 11% 

am poules 6% 



liq uids 6% 

NOVARTIS 

Full Name: Novartis Pharma Ser vices Inc. 

Street Ad dress: 1000 Ljubljana, Tivolska c. 30 

Tel: +386 1 300 7550 

Fax: +386 1 300 7595 







ber): 20 (2006) 

Con tacts (Pharm): Chair man: Niklas Karlberg; 

Gen eral Con tact: Pe ter Pirs 




5): 50-55% 


90-95% 




tion) 

LESCOL XL (cho les terol/triglyceride reg u lat ing 




agent) 





10% 





tab lets 19% 

cap sules 17% 

vi als 10% 

creams 4% 

SOUTH AFRICA 

CIBA VI SION 

Postal Ad dress: PO Box 144, Kemp ton Park 

1600, Gauteng 

Street Ad dress: 72 Steel Road, Kemp ton Park 

1619, Gauteng 

Tel: +27 11 975-1445 

Fax: +27 11 394-8860 

Sub sid iary of: Novartis, South Af rica (100%) 

HEXAL 

Full Name: Hexal Pharma (SA) (Pty) Ltd 

Postal Ad dress: PO Box 15420, West mead 

3608, Pinetown 

Street Ad dress: 46 Ma hog any Road, Ma hog any 

Ridge, West mead, Pinetown 3610, Durban 

Tel: +27 31 700-6801 

Fax: +27 31 700-6809 

Email: hexalsa@iafrica.com 

De scrip tion: De vel oper, im porter, ex porter, dis - 

trib u tor, pro moter, sales/detailer. Ex ports, dis - 

trib utes, pro motes, sells/de tails for other 



non-pre scrip tion), hos pi tal pharmaceuticals, den - 

tal prod ucts, herbal prod ucts. Es tab lished 1992. 

Di vi sions in clude: Den tal Di vi sion; Spe ci al ity Di vi - 

sion; Generic Division; Detail Division. 

Con tacts (Pharm): Chair man: Lyn ton Lomas; 

Com mer cial Op er a tions: Nic Shelver, Daryll 

Marescia; Man u fac ture: Malcolm Blane; Mar ket 

Re search: Nic Shelver; Re search & De vel op ment: 

Lynton Lomas 


NOVARTIS 

Full Name: Novartis South Af rica (Pty) Ltd, 

Pharma Di vi sion 

Postal Ad dress: PO Box 92, Isando 1600, 

Kemp ton Park, Gauteng 

Street Ad dress: 72 Steel Rd, Spar tan, Kemp ton 

Park 1619 

Tel: +27 11 929-9111 

Fax: +27 11 929-2424 

Email: info@novartis.co.za 



bler, im porter, ex porter, dis trib u tor, pro moter, 



pharmaceuticals, bi o log i cal prod ucts, oph thal mic 

prod ucts, vet er i nary pharmaceuticals. Es tab - 

lished 1996. 261 pharmaceutical employees in 

2007. 


ber): 51-100 (2007) 

Con tacts (Pharm): Chair man: Noel Guliwe; 

Com mer cial Op er a tions: M. Howell, S. Burns; 

Mar ket Re search: P. Howe, K. Ngakatau; Re - 



search & De vel op ment: Dr Abofele Khoele; Gen - 

eral Con tact: Pa tri cia Howe 

Par ent of: Ciba Vi sion, South Af rica (100%); 

Novartis An i mal Health, South Af rica (100%); 

Novartis Con sumer Health, South Af rica (100%). 





5): 55-60% 


90-95% 




RITALIN (psychostimulant) 


tion) 










tab lets 25% 

cap sules 14% 

am poules 7% 


NOVARTIS AN I MAL HEALTH 

Postal Ad dress: PO Box 92, Kemp ton Park 

1600, Gauteng 



Full Name: Novartis South Af rica (Pty) Ltd 

Postal Ad dress: Pri vate Bag 92, Kemp ton Park, 

Gauteng 1600 

Street Ad dress: 72 Steel Road, Spar tan, Kemp - 

ton Park 1619, Gauteng 

Tel: +27 11 929-9111 

Fax: +27 11 929-2063 








oph thal mic prod ucts, op ti cal in stru ments, vet er i - 

nary pharmaceuticals. Es tab lished 1997. 35 phar - 

ma ceu ti cal em ploy ees in 2005. Di vi sions in clude: 

Pharmaceuticals; OTC; Ciba Vision; Animal 

Health; Sandoz Generics. 


ber): 18 (2005) 

Con tacts (Pharm): Chair man: Hilton Loring; 

Com mer cial Op er a tions: Rob ert Lee (Sales), 

Michelle Wat son (Mar ket ing); Man u fac ture: 

Tanya Aboo; Mar ket Re search: Michelle Wat son; 

Re search & De vel op ment: Luvuyo Ngoma; Gen - 

eral Con tact: Lindie Gerber 





5): 70-75% 


90-95% 



LAMISIL TOP I CAL (dermatological antifungal) 


DEGORAN PLUS (cold prep a ra tion with out anti-in - 

fec tive) 









liq uids 24% 

gels/sols 23% 


tab lets 15% 

creams 11% 

SANDOZ 

Postal Ad dress: PO Box 154, Isando, Kemp ton 

Park, Gauteng 1600 

Street Ad dress: 72 Steel Road, Spar tan, Kemp - 

ton Park 1619, Gauteng 

Tel: +27 11 929-9000 

Fax: +27 11 929-9015 

Home Page: www.sandoz.co.za 





5): 45-50% 




90-95% 


SANDOZ CO-AMOXYCLA (pen i cil lin broad spec - 

trum) 


SANDOZ LEVOFLOXACI (fluoroquinolone) 

FLUZOL (antifungal sys temic) 

DOBUTREX (car diac stim u lant non-glycoside) 





car diac ther a pies 6% 




tab lets 34% 

cap sules 13% 

vi als 9% 


SOUTH KOREA 

CIBA VI SION 

Full Name: CIBA Vi sion (Ko rea) Ltd. 

Street Ad dress: 6fl. Se oul City Tower Bldg., 581, 

Namdaemunro 5ga, Joong-gu, Se oul 100-803 

Tel: +82 2 768-9000 

Fax: +82 2 768-9299 

Home Page: www.cibavision.co.kr 

De scrip tion: Packager/as sem bler, im porter, ex - 

porter, dis trib u tor, pro moter, sales/detailer. Prod - 

uct ranges in clude: oph thal mic prod ucts, op ti cal 

in stru ments. Es tab lished 1997. 30 phar ma ceu ti - 

cal employees in 2006. 


ber): 13 (2006) 

Con tacts (Pharm): Chair man: Ohn Jong-Seok 

NOVARTIS 

Full Name: Novartis Ko rea Ltd 

Street Ad dress: 7fl. Se oul City Tower Bldg., 581, 

Namdaemunro 5ga, Joong-gu, Se oul 100-803 

Tel: +82 2 768-9000 

Fax: +82 2 785-1939 

Home Page: www.novartis.co.kr 


sales/detailer. Im ports, dis trib utes, sells/de tails 




etetic/nu tri tional prod ucts, oph thal mic prod ucts, 


Di vi sions include: General; Special. 

Con tacts (Pharm): Chair man: Frank Bobe, Pe - 

ter Maag; Com mer cial Op er a tions: Will Charles; 

Mar ket Re search: K.R. Song; Re search & De vel - 

op ment: J.W. Ko; Gen eral Con tact: Seung-Hye 

Ha 


(group: Novartis, Swit zer land); Dong Wha, South 

Ko rea (1%) 




5): 70-75% 


90-95% 





tion) 


agent) 


tion) 









cap sules 10% 

tab lets 6% 


liq uids 3% 

SPAIN 

BEXAL 

Full Name: Bexal Farmaceutica S.A. 

Street Ad dress: Centro Empresarial Osa Mayor, 

Av/Osa Mayor no 4, Area B, Aravaca, 28023 Ma - 

drid 

Tel: +34 91 548 84 04 

Fax: +34 91 548 84 05 

Email: bexal@bexal.es 

Home Page: www.bexal.es 


pro moter, sales/detailer. Im ports for other com - 




prod ucts (branded, unbranded, pre scrip tion, 

non-pre scrip tion). Es tab lished 1999. 120 phar - 



ber): 51-100 (2007) 


An gel Luis Ro dri guez De La Cuerda; Mar ket Re - 

search: Elena Blanco Andreu 

Sub sid iary of: Sandoz, Ger many 




5): 55-60% 


95-100% 


OMEPRAZOL BEX EFG (antiulcerant) 

SIMVASTATINA BEXAL (cho les terol/triglyceride 


ACETILCISTEINA BEX (ex pec to rant) 

CITALOPRAM BEXAL (an ti de pres sant) 

AMLODIPINO BEXAL (cal cium an tag o nist plain) 



13% 






tab lets 48% 


cap sules 22% 


liq uids 2% 

CIBA VI SION 

Full Name: CIBA Vi sion S.A. 

Street Ad dress: C/ Ma rina, 206-208, 08013 

Bar ce lona 

Tel: +34 93 306 47 00 

Fax: +34 93 245 63 44 

Home Page: www.cibavision.es 


NOVARTIS 

Full Name: Novartis Farmaceutica SA 

Postal Ad dress: Apartado 708, 08080 Bar ce lona 

Street Ad dress: Gran Via de les Corts, Catalanes 

764, 08013 Bar ce lona 

Tel: +34 93 306 42 00 

Fax: +34 93 306 44 12 

Home Page: www.novartis.es 


turer, packager/as sem bler, pro moter, 



pharmaceuticals, oph thal mic prod ucts. 


Con tacts (Pharm): Chair man: Je sus Acetillo; 

Com mer cial Op er a tions: Juan Bigorra 


Phar ma ceu ti cal Sales: US$ 950-1,000 mil lion 



5): 50-55% 


85-90% 




tion) 












tab lets 15% 

vi als 8% 

cap sules 8% 

liq uids 7% 


Full Name: Novartis Con sumer Health SA 

Street Ad dress: Calle de la Ma rina, 206, 08013 

Bar ce lona 

Tel: +34 93 306 47 00 

Fax: +34 93 306 47 01 

Home Page: www.novartisconsumerhealth.es 

De scrip tion: De vel oper, dis trib u tor, pro moter, 



non-pre scrip tion). 158 phar ma ceu ti cal em ploy - 

ees in 2008. Di vi sions include: OTC - BU. 


ber): 84 (2008) 

Con tacts (Pharm): Chair man: Mick Clay ton; 

Mar ket Re search: Bernat Subira; Re search & De - 



vel op ment: Joaquin Palacio; Gen eral Con tact: 

Ma rina Asarsa 





5): 75-80% 


85-90% 




CAL CIUM SANDOZ D (cal cium prod uct) 

IDALPREM (tran quil izer) 

EMPORTAL (lax a tive) 




28% 







tab lets 33% 

oint ments 7% 



SANDOZ 

Full Name: Sandoz Farmaceutica S.A. 

Street Ad dress: Centro Empresarial Osa Mayor, 

Av/Osa Mayor no 4, Area B, 28023 Aravaca / Ma - 

drid 

Tel: +34 93 548 95 71 

Fax: +34 93 306 46 29 

Email: sandoz.es@gx.novartis.com 

Home Page: www.es.sandoz.com 





5): 60-65% 


95-100% 


METFORMINA SANDOZ (antidiabetic oral) 

AMOXI CLAV SAN EFG (pen i cil lin broad spec trum) 

OMEPRAZOL SAND EFG (antiulcerant) 

AMOXICILINA SANDOZ (pen i cil lin broad spec - 

trum) 

SIMVASTATINA SANDO (cho les terol/triglyceride 




drugs used in di a be tes 15% 





tab lets 36% 


cap sules 14% 

vi als 7% 

liq uids 4% 

SWEDEN 

CIBA VI SION 

Full Name: CIBA Vi sion Nordic AB 

Street Ad dress: Datavagen 24, S-436 32 Askim 

/ Goteborg 

Tel: +46 31 72 26 600 

Fax: +46 31 28 68 43 

Home Page: www.cvnordic.com 


NOVARTIS 

Full Name: Novartis Sverige AB 

Postal Ad dress: Box 1150, S-183 11 Taby / 

Stock holm 

Street Ad dress: Kemistvagen 1 B, S-183 34 

Taby/Stock holm 

Tel: +46 8 732 32 00 

Fax: +46 8 732 32 01 

Home Page: www.novartis.se 



(branded, pre scrip tion, non-pre scrip tion), di - 

etetic/nu tri tional prod ucts, vet er i nary 



Novartis Con sumer Health. Con sumer Health; 

Animal Health; Pharmaceuticals. 


ber): 21-50 (2007) 

Con tacts (Pharm): Chair man: Dagmar Rosa 

Bjorkesson; Com mer cial Op er a tions: Dagmar 

Rosa Bjorkesson; Mar ket Re search: Karin Bulow; 

Gen eral Con tact: An ders Karnell 







5): 60-65% 


75-80% 



NICOTINELL MINT (antismoking prod uct) 



NICOTINELL FRUIT (antismoking prod uct) 










tab lets 11% 

vi als 10% 

liq uids 9% 

SANDOZ 

Street Ad dress: Berga Alle 1E, S-254 52 

Helsingborg 

Tel: +46 42 15 20 65 

Fax: +46 42 15 41 01 

Home Page: www.sandoz.se 




5): 85-90% 


95-100% 


ENALAPRIL SANDOZ (ACE in hib i tor plain) 

CEFADROXIL SANDOZ (cephalosporin) 

CEFTAZIDIM SANDOZ (cephalosporin) 

ENALAPRIL COMP SAN (ACE in hib i tor com bi na - 

tion) 

CEFOTAXIM SANDOZ (cephalosporin) 








tab lets 40% 


vi als 19% 

cap sules 7% 

liq uids 2% 

SANDOZ AB 

Street Ad dress: Berga Alle 1E, S-254 52 

Helsingborg 

Tel: +46 42 15 20 65 

Fax: +46 42 15 41 01 

Home Page: www.sandoz.se 





bi o log i cal prod ucts. Es tab lished 2006. 15 phar - 



ber): 3 (2008) 

Con tacts (Pharm): Chair man: Hakan 

Josephsson; Com mer cial Op er a tions: Al ex an der 

Brising; Mar ket Re search: Al ex an der Brising; 

Gen eral Con tact: Hakan Josephsson 

Sub sid iary of: Sandoz, Den mark 




5): 85-90% 


95-100% 


METOPROLOL SANDOZ (beta-blocker agent 

plain) 


SIMVASTATIN SAND A (cho les terol/triglyceride 


CEFUROXIM SANDOZ (cephalosporin) 

ZOLPIDEM SANDOZ (hyp notic/sed a tive) 





11% 




tab lets 58% 


cap sules 16% 

vi als 5% 

creams 1% 



SWITZERLAND 

CIBA VI SION 

Full Name: Ciba Vi sion AG 

Street Ad dress: Hardhofstrasse 15, CH-8424 

Embrach 

Tel: +41 1 866 41 00 

Fax: +41 1 866 42 00 

Home Page: www.cibavision.ch 




Man u fac tures for other com pa nies. Prod uct 



tal pharmaceuticals, di ag nos tic prod ucts, oph - 

thal mic prod ucts. Es tab lished 1964. 267 



ber): 1-10 (2005) 

Con tacts (Pharm): Chair man: Luzi von Bid der; 

Com mer cial Op er a tions: Julian Trimmimg; Man u - 

fac ture: Fritz Glaser; Re search & De vel op ment: 

An thony Ellery 


NOVARTIS 

Full Name: Novartis In ter na tional AG 

Postal Ad dress: Postfach, CH-4002 Basel 

Street Ad dress: Fo rum 1, Novartis Cam pus, 

CH-4056 Basel 

Tel: +41 61 324 11 11 

Fax: +41 61 324 80 01 

Home Page: www.novartis.ch 

De scrip tion: Es tab lished 1996. Di vi sions in - 

clude: Healthcare; Nu tri tion; Ag ri busi ness. 

Con tacts (Pharm): Chair man: Dan iel Vasella, 

Ulrich Lehner, Hans-Joerg Rudloff; Com mer cial 

Op er a tions: Thomas Wellauer, Ann Bailey; Mar ket 

Re search: Paul Herrling; Gen eral Con tact: 

Thomas Werlen 

Par ent of: Novartis, Ar gen tina (100%); Sandoz, 

Ar gen tina (100%); Novartis, Aus tra lia (100%); 

Novartis Con sumer Health, Aus tra lia (100%); 

Sandoz, Aus tra lia (100%); Novartis, Aus tria 

(100%); Sandoz, Aus tria (100%); Novartis, Ban - 

gla desh (60%); Ciba Vi sion, Bel gium (100%); 

Novartis, Bel gium (100%); Novartis Con sumer 

Health, Bel gium (100%); Sandoz, Bel gium 

(100%); Novartis, Brazil (100%); Sandoz, Brazil 

(100%); Ciba Vi sion, Can ada (100%); Novartis, 

Can ada (100%); Sandoz, Can ada (100%); 

Novartis, Chile (100%); Novartis, China (100%); 

Novartis, Co lom bia (100%); Lek, Croatia 

(100%); Novartis, Czech Re pub lic (100%); 

Sandoz, Czech Re pub lic (100%); Novartis, Den - 

mark (100%); Sandoz, Den mark (100%); 

Novartis, Ec ua dor (100%); Novartis, Egypt 

(99%); Novartis Con sumer Health, Egypt (96%); 

Novartis, Fin land (100%); Ciba Vi sion, France 

(100%); Novartis, France (100%); Novartis Con - 

sumer Health, France (100%); Sandoz, France 

(100%); 1A Pharma, Ger many (100%); Ciba Vi - 

sion, Ger many (100%); Hexal, Ger many 

(100%); Novartis, Ger many (100%); Novartis 

Con sumer Health, Ger many (100%); Salutas, 

Ger many; Sandoz, Ger many (100%); Sandoz 

Pharma, Ger many (100%); Novartis, Greece 

(100%); Novartis, Hong Kong (100%); Novartis, 

Hun gary (100%); Sandoz, Hun gary (100%); 

Novartis, In dia (51%); Sandoz, In dia (100%); 

Ciba Vi sion, In do ne sia (100%); Novartis, In do ne - 

sia (100%); Novartis, Ire land (100%); Ciba Vi - 

sion, It aly (100%); Novartis, It aly (100%); 

Novartis Con sumer Health, It aly (100%); 

Sandoz, It aly (100%); Ciba Vi sion, Ja pan 

(100%); Novartis, Ja pan (100%); Novartis, Lith - 

u a nia; Novartis, Ma lay sia (100%); Novartis, Mex - 

ico (100%); Novartis, Mo rocco (100%); Novartis, 

Neth er lands (100%); Novartis Con sumer Health, 

Neth er lands (100%); Sandoz, Neth er lands 

(100%); Novartis, New Zea land (100%); 

Novartis, Nor way (100%); Novartis, Pa ki stan 

(98%); Novartis, Pan ama (100%); Novartis, Phil - 

ip pines (100%); Lek, Po land (100%); Novartis, 

Po land (100%); Novartis, Por tu gal (100%); 

Novartis Con sumer Health, Por tu gal (100%); 

Ciba Vi sion, Puerto Rico (100%); Ex Lax, Puerto 

Rico (100%); Lek, Rus sia (100%); Novartis, Rus - 

sia (100%); Novartis Con sumer Health, Rus sia 

(100%); Ciba Vi sion, Sin ga pore (100%); Novartis 

ITD, Sin ga pore (100%); Lek, Slovenia (100%); 

Novartis, South Af rica (100%); Sandoz, South Af - 

rica (100%); Novartis, South Ko rea (99%); Ciba 

Vi sion, Spain (100%); Novartis, Spain (100%); 

Novartis Con sumer Health, Spain (100%); 

Sandoz, Spain (100%); Ciba Vi sion, Swe den 

(100%); Novartis, Swe den (100%); Ciba Vi sion, 

Swit zer land (100%); Novartis Con sumer Health, 

Swit zer land (100%); Novartis Hold ing, Swit zer - 

land (100%); Novartis Pharmaceuticals, Swit zer - 

land (100%); Roche, Swit zer land (33.2%); 

Sandoz, Swit zer land (100%); Speedel, Swit zer - 

land; Novartis, Tai wan (100%); Novartis, Thai - 

land (100%); Novartis, Tur key (100%); Sandoz, 



Tur key (100%); Ciba Vi sion, UK (100%); NeuTec, 

UK; Novartis Con sumer Health, UK (100%); 

Novartis Pharmaceuticals, UK (100%); Sandoz, 

UK (100%); SkyePharma, UK (2%); Vericore, UK 

(100%); Alcon, USA (25%); Ciba Vi sion, USA 

(100%); Eon Labs, USA (100%); Idenix, USA 

(56%); Lek, USA (100%); Novartis Con sumer 

Health, USA (100%); Novartis Pharmaceuticals, 

USA (100%); Novartis Vaccines, USA (100%); 

Protez, USA (100%) (acquired 2008); Sandoz, 

USA (100%); Novartis, Venezuela (100%). 


Full Name: Novartis Con sumer Health Schweiz 

AG 

Postal Ad dress: Postfach, CH-3001 Bern 

Street Ad dress: Monbijoustrasse 118, CH-3007 

Bern 

Tel: +41 31 377 61 11 

Fax: +41 31 377 61 00 

Email: info@novartis-con sumer-health.ch 

Home Page: www.con sumer-health.ch 



ceu ti cal prod ucts (branded, non-pre scrip tion), 

herbal prod ucts. Es tab lished 1998. 114 phar ma - 


OTC; Medical Nutrition. 


ber): 30 (2007) 

Con tacts (Pharm): Chair man: Mick Clay ton; 

Com mer cial Op er a tions: Dominique Giulini; Man - 

u fac ture: Adil Naamar; Mar ket Re search: 

Benjamin Brechbuhler; Re search & De vel op ment: 

Markus Unkauf; Gen eral Con tact: Mick Clayton 





5): 50-55% 


75-80% 


NEO CITRAN (cold prep a ra tion with out anti-in fec - 

tive) 

MEBUCAINE F (throat prep a ra tion) 











liq uids 24% 

gels/sols 16% 



tab lets 11% 


Full Name: Novartis Pharma Schweiz AG 

Postal Ad dress: Postfach, CH-3001 Bern 

Street Ad dress: Monbijoustrasse 118, CH-3001 

Bern 

Tel: +41 31 377 51 11 

Fax: +41 31 377 52 11 

Home Page: www.novartispharma.ch 

De scrip tion: De vel oper, dis trib u tor, pro moter, 

sales/detailer. Dis trib utes for other com pa nies. 



pharmaceuticals, bio tech nol ogy prod ucts. Es tab - 


2005. 


ber): 51-100 (2005) 

Con tacts (Pharm): Chair man: Theodor Sproll; 

Gen eral Con tact: Federica Castellano 





5): 55-60% 


85-90% 



uct) 



tion) 



agent) 











am poules 16% 

tab lets 12% 

cap sules 10% 


SANDOZ 

Full Name: Sandoz Pharmaceuticals AG 

Postal Ad dress: Postfach 5051, CH-6330 Cham 

2 

Street Ad dress: Hinterbergstrasse 24, CH-6330 

Cham 

Tel: +41 61 324 11 11 

Fax: +41 61 324 80 01 





5): 55-60% 


90-95% 


OMEPRAZOL SDZ ECO (antiulcerant) 

SIMCORA (cho les terol/triglyceride reg u lat ing 


CITALOPRAM ECOSOL (an ti de pres sant) 

ECOFENAC (antirheumatic non-steroidal; 


TORASIS (di uretic) 





12% 





tab lets 32% 

cap sules 15% 

gels/sols 2% 


SYRIA 

NOVARTIS 


Postal Ad dress: PO Box 3551, Da mas cus 

Street Ad dress: Abou Roumaneh, Ab dul Al 

Malek Ibn Marwan str., Sabbagh & Tarabishi 

Bldg., 1st floor, Da mas cus 

Tel: +963 11 334 0115 

Fax: +963 11 334 0046 

TAIWAN 

CIBA VI SION 

Full Name: CIBA Vi sion Tai wan Co., Ltd. 

Street Ad dress: 10F, No.131, ASec.3, 

Min-Sheng Est. Road, Tai pei 105 

Tel: +886 2 3518-5678 

Fax: +886 2 2715-2358 

Home Page: www.cibavision.com.tw 

NOVARTIS 

Full Name: Novartis (Tai wan) Co., Ltd. 

Street Ad dress: 11Fl. No.99, Sec.2, Jen-Ai 

Road, Tai pei 100 

Tel: +886 e 2341-6580 

Fax: +886 2 2343-2096 

Home Page: www.tw.novartis.com 

De scrip tion: Re searcher, im porter, pro moter, 




etetic/nu tri tional prod ucts, med i cal equip ment, 


ma ceu ti cal em ploy ees in 2007. Di vi sions in clude: 

Phar ma ceu ti cal division; Consumer Health 

division. 


ber): 101-500 (2007) 

Con tacts (Pharm): Chair man: Alex Chang; 

Com mer cial Op er a tions: Satina Lin, Sid Lin; Mar - 

ket Re search: Nick Wang; Re search & De vel op - 

ment: J.C. Wu; Gen eral Con tact: Linda Liu 





5): 65-70% 


90-95% 





tion) 

LESCOL XL (cho les terol/triglyceride reg u lat ing 



agent) 











cap sules 14% 

tab lets 7% 


liq uids 4% 


Full Name: Novartis (Tai wan) Co., Ltd. 

Street Ad dress: 11Fl. No.99, Sec.2, Jen-Ai 

Road, Tai pei 100 

THAILAND 

CIBA VI SION 

Full Name: CIBA Vi sion (Thai land) Lim ited 

Street Ad dress: 622 Em po rium Tower, 15th/1-8 

Fl., Sukhumvit Road, Kwaeng Klongton, Khet 

Klongtoey, Bang kok 10110 

Tel: +66 2 685 0999 

Fax: +66 2 685 0966 

Email: cvision@ksc.th.com 

Home Page: www.cibavision.com 



ceu ti cal prod ucts (branded, pre scrip tion), oph - 

thal mic prod ucts, op ti cal in stru ments. Established 

1991. 

Con tacts (Pharm): Chair man: Orawan 

Santanaporn; Com mer cial Op er a tions: 

Chattaporn Suwattanakuldee 

NOVARTIS 

Full Name: Novartis (Thai land) Lim ited 

Street Ad dress: 622 Em po rium Tower, 15th 

Floor, Sukhumvit Road, Kwaeng Klongton, Khet 

Klongtoey, Bang kok 10110 

Tel: +66 2 685 0999 

Fax: +66 2 685 0770 

E m a i l : 

webmaster.phthbk@pharma.novartis.com 

Home Page: www.th.novartis.com 



(branded), hos pi tal pharmaceuticals, bi o log i cal 

prod ucts, bio tech nol ogy prod ucts, med i cal sup - 

plies, oph thal mic prod ucts. Es tab lished 1997. Di - 

vi sions in clude: Sandoz. Pri mary Care & Ma ture 

Prod uct; On col ogy; Ophthalmics; Tranplantation. 

Con tacts (Pharm): Chair man: Pe ter Jager; 

Com mer cial Op er a tions: Pattanapong 

Jaroonpipatkul, Nuchanard Pinyapong; Re search 

& De vel op ment: Siriporn Thaithumyanon 





5): 50-55% 


90-95% 















tab lets 14% 

liq uids 14% 

cap sules 9% 


TURKEY 

ILSAN ILAC 

Street Ad dress: Gebze Plastikciler Or ga nize 

Sanayi, Bolgesi Ataturk Bulvan 9., Cadde, No. 1, 

41400 Gebze Kocaeli 

Tel: +90 262 751 31 01 

Fax: +90 262 751 30 36/37 

Email: info@ilsan.com.tr 

Home Page: www.ilsan.com.tr 

De scrip tion: Man u fac turer, re searcher, de vel - 

oper, im porter, ex porter, dis trib u tor, 

sales/detailer. Man u fac tures, im ports, dis trib utes, 



scrip tion, non-pre scrip tion), raw ma te ri als, herbal 

products. Established 1964. 

Con tacts (Pharm): Chair man: Dr Bedri Toker; 

Com mer cial Op er a tions: Celalettin Ercan; Man u - 

fac ture: Dogan Guzel; Mar ket Re search: Asuman 



Akgun; Re search & De vel op ment: Serap 

Tutumluer 


NOVARTIS 

Full Name: Novartis Saglik, Gida ve Tarim 

Urunleri Sanayi ve Ticaret A.S. 

Street Ad dress: Barbaros Bulvari No 83, 

Besiktas, 34353 Is tan bul 

Tel: +90 212 326 91 00 

Fax: +90 212 236 78 43 

Email: novartis.tr@pharma.novartis.com 

Home Page: www.novartis.com.tr 



u tor, pro moter, sales/detailer. Man u fac tures, ex - 

ports for other com pa nies. Prod uct ranges 



pharmaceuticals, bi o log i cal prod ucts, di etetic/nu - 

tri tional prod ucts, op ti cal in stru ments, oph thal mic 

prod ucts, vet er i nary pharmaceuticals. Es tab - 


2005. Di vi sions include: Pharma; Consumer 

Health; Ciba Vision; Nutrition. 


ber): 420 (2005) 

Con tacts (Pharm): Chair man: Altan Demirdere; 

Com mer cial Op er a tions: Guldem Berkman (PC & 

MP), Tolay Tdroz (CPH), Dilek Boke (Onc), Emre 

Eran (Tx); Man u fac ture: John Paul Man ning; Mar - 

ket Re search: Gamze Alatan; Re search & De vel - 

op ment: Ugur Ozkutlu; Gen eral Con tact: Kurt 

Gamze Alatan 





5): 50-55% 


90-95% 




tion) 

FORADIL COMBI (B2-stim u lant/corticoid com bi - 

na tion) 


antirheumatic top i cal; oph thal mic anti-in flam ma - 

tory non-steroidal) 










cap sules 19% 

liq uids 9% 

tab lets 7% 



Full Name: Novartis Saglik, Gida ve Tarim 

Urunleri Sanayi ve Ticaret A.S. 

Street Ad dress: Is Kuleleri Kule-2 Kat:4, 4. 

Levent, 34330 Is tan bul 

Tel: +90 212 339 28 00 

Fax: +90 212 279 21 44 

Home Page: www.novartis.com.tr 




5): 85-90% 


85-90% 


OTRIVINE (na sal prep a ra tion top i cal) 

SINECOD (antitussive) 

VENORUTON (var i cose ther apy sys temic) 


tive) 

FENISTIL (antipruritic) 





20% 




liq uids 40% 


tab lets 16% 

gels/sols 8% 

creams 7% 

SANDOZ 

Full Name: Sandoz Ilac Sanayi ve Ticaret A.S. 

Street Ad dress: GEPOSB Ataturk Bulvari 9. 

Cadde No. 1, 41400 Gebze - Kocaeli 

Tel: +90 216 458 33 00 

Fax: +90 262 751 30 36 



Home Page: www.sandoz.com.tr 





5): 75-80% 


95-100% 


PANTO (antiulcerant) 

LANSAZOL (antiulcerant) 

AMOKSILAV (pen i cil lin broad spec trum) 

VERMIDON (an al ge sic non-nar cotic) 

GLUKOFEN (antidiabetic oral) 






drugs used in di a be tes 6% 



liq uids 16% 

cap sules 16% 

tab lets 15% 

am poules 2% 

UK 

CIBA VI SION 

Full Name: CV Man u fac tur ing and Sup ply (UK) 

Lim ited 

Street Ad dress: Guild ford Road Trad ing Es tate, 

Farn ham, Sur rey GU9 9PZ 

Tel: +44 1252 712222 

Fax: +44 1252 733207 

Home Page: www.cibavision.co.uk 


LAGAP 

Full Name: Lagap Pharmaceuticals Ltd 

Street Ad dress: Woolmer Way, Unit 37, Bordon, 

Hamp shire GU35 9QE 

Tel: +44 1420 478301 

Fax: +44 1420 474427 

De scrip tion: De vel oper, for mu la tor, im porter, 


Dis trib utes, sells/de tails for other com pa nies. 



tion), hos pi tal pharmaceuticals. Established 1983. 

Con tacts (Pharm): Chair man: Da vid G. 

Stubbins; Com mer cial Op er a tions: A. Clarke; Re - 

search & De vel op ment: S. Ashworth 


Full Name: Novartis Con sumer Health UK Ltd 

Street Ad dress: Wimblehurst Road, Horsham, 

West Sus sex RH12 5AB 

Tel: +44 1403 210211 

Fax: +44 1403 323939 

Home Page: www.novartis.co.uk 


porter, pro moter, sales/detailer. Prod uct ranges 


scrip tion), di etetic/nu tri tional prod ucts, herbal 

prod ucts. Es tab lished 1996. 250 phar ma ceu ti cal 






5): 65-70% 


90-95% 



OTRIVINE (na sal prep a ra tion top i cal) 

SAVLON (an ti sep tic/dis in fec tant) 

VOLTAROL P (antirheumatic top i cal; 

antirheumatic non-steroidal) 

EURAX (antipruritic) 






an ti sep tics and dis in fec tants 8% 


liq uids 27% 


creams 17% 


gels/sols 10% 


Full Name: Novartis Pharmaceuticals UK Lim ited 

Street Ad dress: Frimley Busi ness Park, 

Camberley, Sur rey GU16 7SR 

Tel: +44 1276 692255 

Fax: +44 1276 692508 

Home Page: www.novartis.co.uk 







(branded, pre scrip tion), bio tech nol ogy products. 


Con tacts (Pharm): Chair man: Bill Fullagar; 

Com mer cial Op er a tions: Justin Van Gennep; 

Man u fac ture: Mike Benzie; Mar ket Re search: Da - 

vid Hor ton; Re search & De vel op ment: Lester 

Whitbread 





5): 60-65% 


80-85% 





uct) 











cap sules 24% 

tab lets 11% 

vi als 10% 


SANDOZ 

Full Name: Sandoz Ltd 

Street Ad dress: Unit 37, Woolmer Way, Bordon, 

Hamp shire GU35 9QE 

Tel: +44 1420 478301 

Fax: +44 1420 474427 

Home Page: www.uk.sandoz.com 





5): 55-60% 


90-95% 


GABAPENTIN SANDOZ (antiepileptic) 

CLINDAMYCIN SANDOZ (macrolide/sim i lar type) 

BEDRANOL (beta-blocker agent plain) 

FENTANYL SANDOZ (an al ge sic nar cotic) 









cap sules 50% 


tab lets 10% 


liq uids 6% 

TILLOMED 

Full Name: Tillomed Lab o ra to ries Lim ited 

Street Ad dress: 3 Howard Road, Eaton Socon, 

St Neots, Cam bridge shire PE19 3ET 

Tel: +44 1480 402400 

Fax: +44 1480 402402 

Email: en qui ries@tillomed.co.uk 

Home Page: www.tillomed.com 

De scrip tion: Prod uct ranges in clude: phar ma - 

ceu ti cal prod ucts (branded, unbranded). Es tab - 

lished 1991. 

Con tacts (Pharm): Chair man: Musharraf Ginai; 

Gen eral Con tact: Musharraf Ginai 

UKRAINE 

HEXAL 

Full Name: Hexal AG 

Street Ad dress: 145 Borschagivska str., 03056 

Kiev 




5): 75-80% 


85-90% 






ACC HOT DRINK (ex pec to rant) 


non-HIV) 









6% 


tab lets 27% 

gels/sols 24% 



cap sules 8% 

NOVARTIS 


Street Ad dress: 29, Bereznyakovskaya St., 

02098 Kiev 

Tel: +380 44 490 53 38 

Fax: +380 44 490 53 39 


Con tacts (Pharm): Chair man: Irina Karakai; 

Gen eral Con tact: Irina Karakai 



SA 

Street Ad dress: Beriaznyakovskaya St. 29, 7th 

floor, 02098 Kiev 

Tel: +380 44 496 09 50 

Fax: +380 44 496 09 51 




5): 90-95% 


90-95% 



TERAFLU (cold prep a ra tion with out anti-in fec tive) 

LAMISIL (dermatological antifungal) 










liq uids 40% 


gels/sols 14% 

creams 10% 


SANDOZ 

Full Name: Sandoz Rep re sen ta tive Of fice 

Ukraine 

Street Ad dress: Polevaya Street, 4 fl. 24d, 

03056 Kiev 

Tel: +380 44 495 28 66/29 41 

Fax: +380 44 495 29 43 





tion), hos pi tal pharmaceuticals, raw ma te ri als, bi - 

o log i cal prod ucts, bio tech nol ogy prod ucts, 

di etetic/nu tri tional prod ucts, herbal prod ucts, 


c.300 pharmaceutical employees in 2008. 


ber): 180 (2008) 

Con tacts (Pharm): Chair man: Dr Ray Masch; 

Gen eral Con tact: Dr Ray Masch 




5): 65-70% 


80-85% 



PERSEN (hyp notic/sed a tive) 


BRONCHO MUNAL (vac cine other) 

AMOKSIKLAV 2X (pen i cil lin broad spec trum) 






vac cines 8% 



cap sules 35% 


tab lets 8% 

liq uids 7% 

am poules 6% 

UNITED ARAB EMIRATES 

NOVARTIS 




Postal Ad dress: PO Box 23510, Dubai 

Street Ad dress: Twin Tow ers, Suite Nr.1401, 

Beniyas Road, Deira, Dubai 

Tel: +971 4 227 8005 

Fax: +971 4 223 5369 




pharmaceuticals, oph thal mic products. 




5): 75-80% 


90-95% 





tion) 


LAMISIL NP (antifungal sys temic) 









tab lets 27% 

liq uids 9% 

cap sules 7% 

am poules 4% 

URUGUAY 

NOVARTIS 

Full Name: Novartis Uru guay S.A. 

Street Ad dress: Casilla Correo 605, 11200 Mon - 

te vi deo 

Tel: +598 2 4133694 

Fax: +598 2 4033245 


tor, pro moter, sales/detailer. Im ports, dis trib utes, 





bio tech nol ogy prod ucts, oph thal mic products. 


Con tacts (Pharm): Chair man: Cesar Casal; 

Com mer cial Op er a tions: Julio Godin; Mar ket Re - 

search: Arnoldo Giganda, Luis Ro dri guez 

USA 

CHIRON 

Full Name: Chiron Cor po ra tion 

Street Ad dress: 4560 Hor ton Street, Emeryville, 

Cal i for nia 94608-2916 

Tel: +1 510 655 8730 

Fax: +1 510 655 9910 

Email: com mu ni ca tions@chiron.com 

Home Page: www.chiron.com 


oper. Prod uct ranges in clude: phar ma ceu ti cal 

prod ucts (branded, unbranded). Es tab lished 

1981. 

Con tacts (Pharm): Chair man: Howard Pien, 

Sean P. Lance, Dr Jack Goldstein; Com mer cial 

Op er a tions: Bryan Walser; Re search & De vel op - 

ment: Rino Rappuoli 

Par ent of: Chiron Vac cines, UK (100%); Biocine, 

USA (di vi sion); Lynx Ther a peu tics, USA (13%); 

Ma trix, USA (100%). 

CIBA VI SION 

Full Name: CIBA Vi sion Cor po ra tion 

Street Ad dress: 11460 Johns Creek Park way, 

Du luth, Geor gia 30097 

Tel: +1 770 476 3937 

Fax: +1 770 418 4256 

Home Page: www.cibavision.com 


oper, im porter, dis trib u tor, pro moter. Prod uct 



tal pharmaceuticals, di ag nos tic products. 






5): n.a. 


95-100% 


VISUDYNE (oc u lar antineovascularization prod - 

uct) 

AOSEPT CLEAR CARE (con tact lens prep a ra tion) 

AQUIFY MPS (con tact lens prep a ra tion) 

LENSEPT (con tact lens prep a ra tion) 



AOSEPT (con tact lens prep a ra tion) 



non-ther a peu tics other 1% 


vi als 58% 

liq uids 41% 

med i cal aids 1% 

tab lets 1% 

in fu sions - 

EON LABS 

Full Name: Eon Labs, Inc 

Street Ad dress: 1999 Marcus Av e nue, Lake 

Suc cess, New York 11042 

Tel: +1 516 478 9700 

Fax: +1 516 478 9810 

Home Page: www.eonlabs.com 


sales/detailer. Man u fac tures, dis trib utes, 


in clude: phar ma ceu ti cal prod ucts (unbranded, 

pre scrip tion). Established 1992. 

Con tacts (Pharm): Chair man: Dr Bernhard 

Hampl; Com mer cial Op er a tions: Frank J. Della 

Fera; Man u fac ture: Wil liam Eversgerd 


GERBER 

Full Name: Gerber Prod ucts Com pany, Fremont 

Site 

Street Ad dress: 445 State Street, Fremont, 

Mich i gan 49413 

Tel: +1 231 928 2000 

Fax: +1 231 928 2723 

Home Page: www.gerber.com 

LEK 

Full Name: Lek Pharmaceuticals, Inc. 

Street Ad dress: 115 North Third Street, Suite 

301, Wilmington, North Carolina 28401 

Tel: +1 910 362 0021 

Fax: +1 910 362 0021 


clude: phar ma ceu ti cal prod ucts (unbranded, pre - 

scrip tion), fine chem i cals. 

Con tacts (Pharm): Chair man: Paul Kleutghen; 

Com mer cial Op er a tions: J.B. Davies; Mar ket Re - 

search: J.B. Davies; Gen eral Con tact: J.B. Davis 



Full Name: Novartis Con sumer Health, Inc. 

Street Ad dress: 200 Kimball Drive, Parsippany, 

New Jer sey 07054-0622 

Tel: +1 973 503 8000 

Fax: +1 973 503 8400 

Home Page: www.us.novartis.com 


tor, packager/as sem bler, im porter, dis trib u tor, 



non-pre scrip tion), hos pi tal pharmaceuticals, vet - 

er i nary pharmaceuticals. Established 1997. 


Lisa Gon za lez, Tom McGuire; Man u fac ture: Tom 

Berry; Re search & De vel op ment: Dr Mark Gelbert 





5): 65-70% 


85-90% 


EXCEDRIN EX STR (an al ge sic non-nar cotic) 

EXCEDRIN MI GRAINE (antimigraine prep a ra tion) 

TRANSDERM-SCOP (antiemetic/antinauseant) 

NIC O TINE (antismoking prod uct) 

DENAVIR (vi ral in fec tion prod uct top i cal) 




antiemetics/antinauseants 9% 





tab lets 18% 

liq uids 16% 


creams 9% 

NOVARTIS NU TRI TION 

Full Name: Novartis Nu tri tion Corp. 

Street Ad dress: 5320 West 23rd Street, St Louis 

Park, Min ne sota 55416 

Tel: +1 952 848 6000 

Fax: +1 952 848 6050 


Full Name: Novartis Pharmaceuticals Corp 

Street Ad dress: One Health Plaza, East 

Hanover, New Jer sey 07936-1080 

Tel: +1 862 778 8300 

Fax: +1 973 781 8265 



Home Page: www.pharma.us.novartis.com 


oper, im porter, ex porter, dis trib u tor, pro moter. 


(branded, pre scrip tion, non-pre scrip tion). 


Con tacts (Pharm): Chair man: Burt Rosen, 

Paulo Costa; Com mer cial Op er a tions: Burt Rosen; 

Mar ket Re search: J. Ziemers; Re search & De vel - 

op ment: D. Hauser, R. Calipre, Paul Sekhri 

Par ent of: Novogyne, USA (51%). 



lion 



5): 65-70% 


90-95% 




tion) 











tab lets 44% 


cap sules 12% 


liq uids 5% 

NOVARTIS VAC CINES 

Full Name: Novartis Vac cines & Di ag nos tics 

Head quar ters 

Street Ad dress: 4560 Hor ton Street, Emeryville, 

Cal i for nia 94608-2916 

Tel: +1 510 655 8730 

Fax: +1 510 655 9910 

Home Page: www.novartisvaccines.com 




95-100% 


5): n.a. 



FLUVIRIN (vac cine pure) 

RABAVERT (vac cine pure) 


vac cines 100% 


vi als 93% 


SANDOZ 

Full Name: Sandoz, Inc. 

Street Ad dress: 506 Car ne gie Cen ter, Suite 

400, Prince ton, New Jer sey 08540 

Tel: +1 609 627 8500 

Fax: +1 609 627 8659 

Home Page: www.us.sandoz.com 


tor, dis trib u tor, sales/detailer. Dis trib utes, pro - 

motes, sells/de tails for other com pa nies. Prod uct 


(unbranded, pre scrip tion), hos pi tal 

pharmaceuticals. Es tab lished 1946. 1,250 phar - 



ber): 1-10 (2007) 

Con tacts (Pharm): Chair man: Bernhard 

Hampl; Com mer cial Op er a tions: Frank Della Fera; 

Mar ket Re search: Barbara Purcell; Gen eral Con - 

tact: Frank Della Fera 



lion 



5): 60-65% 


85-90% 


METOPROLOL SUCCIN (beta-blocker agent plain) 

AMLODIP BES/BENAZ (ACE in hib i tor com bi na - 

tion) 

FENTANYL (an al ge sic nar cotic) 

AMOX TR/POT CLAVUL (pen i cil lin broad spec - 

trum) 

CEFDINIR (cephalosporin) 










cap sules 26% 


tab lets 22% 

liq uids 11% 


UZBEKISTAN 

LEK 

Full Name: Lek d.d., Rep re sen ta tive Of fice. 

Street Ad dress: 700000 Tashkent, 3, L. To lstoy 

street, ap. 14-15 

Tel: +998 71 137 00 38 

Fax: +998 71 137 06 92 

Email: lektash@globalnet.uz 

De scrip tion: Rep re sen ta tive of fice. Re searcher, 

pro moter. Prod uct ranges in clude: phar ma ceu ti - 


non-pre scrip tion), hos pi tal pharmaceuticals. 


Con tacts (Pharm): Chair man: Alisher 

Iskhakov; Gen eral Con tact: Alisher Iskhakov 

VENEZUELA 

NOVARTIS 

Full Name: Novartis de Ven e zuela S.A. 

Postal Ad dress: Apartado 68097, Ca ra cas 

1062-A 

Street Ad dress: 3ra. Transversal de Los Ruices, 

Edificio Novartis, Urb. Los Ruices, Ca ra cas 1071 

Tel: +58 212 239-40-11 

Fax: +58 212 239-10-68 

Home Page: www.novartis.com.ve 


de vel oper, sales/detailer. Im ports, dis trib utes, 

pro motes for other com pa nies. Prod uct ranges in - 


unbranded, pre scrip tion, non-pre scrip tion), hos - 

pi tal pharmaceuticals, oph thal mic prod ucts. Es - 

tab lished 1997. 362 phar ma ceu ti cal em ploy ees in 

2007. Di vi sions in clude: Pharma; Sandoz; OTC; 

Ciba Vision. 


ber): 220 (2007) 

Con tacts (Pharm): Chair man: Cesar Casal; 

Com mer cial Op er a tions: Luis Marsicano; Man u - 

fac ture: Al ex an der Altamar; Re search & 

De vel op ment: Gustavo Rivas 





5): 80-85% 


90-95% 




tion) 












cap sules 15% 

liq uids 13% 

tab lets 11% 


NOVARTIS NU TRI TION 

Full Name: Novartis Nu tri tion de Ven e zuela, S.A. 

Postal Ad dress: Apartado 80532, Ca ra cas 

1080A 

Street Ad dress: Calle del Arenal, Edf.Palacio, 

Piso 2, Zona La Trin i dad, Mun.Baruta, 

Edo.Miranda 1081, Ca ra cas 1081 

Tel: +58 212 949-00-00 

Fax: +58 212 949-00-59 


Con tacts (Pharm): Gen eral Con tact: Chris tine 

John son 




5): 90-95% 


75-80% 


VOLTAREN TOPICO (antirheumatic top i cal) 

LAMISIL TOPICO (dermatological antifungal) 

PARSEL (antimigraine prep a ra tion) 




tive) 

PROCTO GLYVENOL (antihemorrhoidal top i cal) 







9% 


gels/sols 23% 


creams 15% 

liq uids 14% 


VIETNAM 

HEXAL 

Full Name: Hexal AG, Rep re sen ta tive Of fice Viet - 

nam 

Street Ad dress: Rm. 301B, 649 Kim Ma, 

V-Tower, Ba Dinh Dis trict, Ha noi 

Tel: +84 4 766 4572 

Fax: +84 4 766 4573 

Email: hexalvn@hn.vnn.vn 


Con tacts (Pharm): Chair man: Dang Thi Minh 

Phuong 

SANDOZ 

Full Name: Sandoz GmbH, Ho Chi Minh City 

Street Ad dress: Phoe nix Build ing, 12-13 bis Ky 

Dong Street, 8th Floor, Dis trict 3, Ho Chi Minh City 

Tel: +84 8 526 0685 

Fax: +84 8 290 5086 


IMS COM PANY PRO FILES APPENDIX - CURRENT COMPANY PROFILES 

Appendix - Current Company Profiles 

AMER ICAS 

Apotex Can ada 

Biovail Can ada 

Abbott USA 

Allergan USA 

Amgen USA 

Barr USA 

Bausch & Lomb USA 

Baxter In ter na tional USA 

Biogen IDEC USA 

Bris tol-Myers Squibb USA 

Cephalon USA 

Eli Lilly USA 

Endo Pharmaceuticals USA 

For est Lab o ra tories USA 

Genentech USA 

Genzyme USA 

Gilead USA 

Hu man Ge nome Sci ences USA 

Isis USA 

John son & John son USA 

King USA 

Merck & Co USA 

Mil len nium USA 

Mylan USA 

Par Pharmaceuticals USA 

Pfizer USA 

Procter & Gam ble USA 

Schering-Plough USA 

Sepracor USA 

Valeant USA 

Wat son USA 

Wyeth USA 

ASIA 

Dr Reddy's India 

Ranbaxy India 

Astellas Japan 

Chugai Ja pan 

Daiichi Sankyo Ja pan 

Dainippon Sumitomo Japan 

Eisai Ja pan 

Kowa Japan 

Kyowa Hakko Japan 

Meiji Seika Japan 

Mitsubishi Tanabe Japan 

Ono Japan 

Otsuka Ja pan 

Shionogi Ja pan 

Taisho Ja pan 

Takeda Ja pan 

EU ROPE 

Sol vay Bel gium 

UCB Bel gium 

Zentiva Czech Republic 

LEO Pharma Den mark 

Lundbeck Den mark 

Novo Nordisk Den mark 

Ipsen France 

Pi erre Fabre France 

sanofi-aventis France 

Servier France 

Bayer Ger many 

Boehringer Ingelheim Ger many 

Gruenenthal Ger many 

Fresenius Germany 

Merck KGaA Ger many 

ratiopharm Germany 

Stada Germany 

Gedeon Rich ter Hun gary 

Actavis Iceland 

Elan Ire land 

Teva Is rael 

Chiesi It aly 

Menarini It aly 

Recordati It aly 

Sigma-Tau It aly 

Almirall Spain 

Esteve Spain 

Ferring Switzerland 

Mundipharma Switzerland 

Nes tle Swit zer land 

Novartis Swit zer land 

Roche Swit zer land 

Nycomed Pharma Switzerland 

Acambis UK 

AstraZeneca UK 

GlaxoSmithKline UK 

Shire UK 

SkyePharma UK 

Vernalis UK

IMS Company Profiles - Report Buyer

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?