IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Chiesi has also in de pend ently de vel oped Delapride (delapril/indapamide), a com bi na tion of delapril and
the di uretic indapamide. Delapride was launched in It aly for the treat ment of hy per ten sion in 1997. The
com bi na tion acts syn er gis ti cally and is in di cated in pa tients with mod er ate to se vere hy per ten sion. It was
launched in Tu ni sia in 2005 and in Austria in March 2006.
ADVICOR (ni a cin + lovastatin ex tended re lease) is ap proved in the USA for the treat ment of mul ti ple
lipid dis or ders.
Li cens ing: Takeda (through TPNA) signed an agree ment with Kos (now Abbott, USA) in 2003, to co-pro -
mote the prod uct from Jan u ary 2004. An iden ti cal agree ment was signed for Kos’s other cho les terol
prod uct, Niaspan (ni a cin). Both agree ments are due to last three years, but can be ex tended. If the com -
pa nies do not re new the part ner ship, Takeda will be el i gi ble to re ceive de clin ing tail pay ments for a pe riod
of three years fol low ing 2006. Un der the agree ment, TPNA’s 1,000-strong US sales force will co-pro mote
the prod ucts and Takeda will re ceive an un dis closed per cent age of net sales for Kos’s (now Abbott’s) cur -
rent cho les terol franchise above a specific baseline level.
BLOPRESS (candesartan cilexetil), a long-act ing an gio ten sin II an tag o nist (AIIA) for the treat ment of
hy per ten sion, de vel oped by Takeda, was first launched in Ger many in 1997, by Takeda Pharma, which
co-mar kets it with AstraZeneca (UK). It is mainly sold over seas by li censee AstraZeneca, and is now
avail able in over 70 coun tries. In 1999, Takeda launched Blopress in Ja pan where ap proval in heart fail -
ure is still awaited fol low ing a filing in 2002.
In 2005, a safety warn ing was added to the la bel of four AIIAs, in clud ing Blopress, for risk of low blood
sugar lev els fol low ing sev eral re ports in pa tients tak ing the prod ucts. In 2003, use pre cau tions for
Blopress in Ja pan have been mod i fied to in clude state ments on the pos si bil ity of in ter sti tial pneu mo nia, as
well as fe ver, cough, and breath ing dif fi cul ties, and treat ment should be dis con tin ued should these symp -
toms ap pear, says a Min is try of Health, Labor and Welfare’s ADR bulletin.
In 2004, candesartan was ap proved in the EU, ex cept France and ex panded mem ber states, for chronic
heart fail ure (CHF). This al lows its use both for heart fail ure pa tients in ad di tion to stan dard back ground
ther apy in clud ing ACE-in hib i tors, and in pa tients in tol er ant of ACE-in hib i tor ther apy. In 2004,
AstraZeneca and Takeda com pleted the EU’s mu tual rec og ni tion pro ce dure for ap proval of a 32 mg tab let
of candesartan. Candesartan is al ready avail able in 2, 4, 8, and 16 mg doses and the new strength will be
launched on a coun try-by-coun try ba sis. The two new pa tient groups were clearly shown to ben e fit from
the prod uct in the CHARM-Added and CHARM-Al ter na tive stud ies re ported in the 2003 Eu ro pean So ci ety
of Car di ol ogy meet ing. The new la bel will not, how ever, al low candesartan cilexetil’s use in heart fail ure
pa tients with pre served left ven tric u lar func tion. These ac count for around half of all CHF pa tients and al -
though they have better out comes than those with small ejec tion frac tions, they still ex pe ri ence high
rates of mor tal ity and hos pi tal iza tion for heart fail ure. The EU ap proval does not cover France, where as
for the ini tial hy per ten sion in di ca tion, a na tional pro ce dure is being pursued. Also, the drug does not get
approval for the expanded member states.
The FDA granted ap proval of Atacand for heart fail ure in 2005 in the US in pa tients with left ven tric u lar
sys tolic dys func tion, to re duce car dio vas cu lar death and to re duce heart fail ure hos pi tal iza tions. Atacand
had pre vi ously only been avail able in the US for hy per ten sion, and this was based on the CHARM-Al ter na -
tive study re sults. This was fol lowed by FDA ap proval in May 2005 of Atacand in com bi na tion with an ACE
in hib i tor to re duce car dio vas cu lar death and heart fail ure hos pi tal iza tions in heart fail ure pa tients with left
ven tric u lar sys tolic dys func tion (with ejec tion frac tion be low 40%). This lat est ap proval was largely based
on re sults of the CHARM-Added study. Data from the third CHARM-Pre served study in the pop u la tion with
ejec tion frac tion above 40% only showed a trend to wards ben e fit for the pri mary end point, de spite a sig -
nif i cant reduction in the secondary endpoint of heart failure hospitalization.
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