IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Prevacid. At the time of the an nounce ment in Sep tem ber 2004, un der the deal TAP would pay costs of all
fur ther de vel op ment, test ing, reg u la tory ap proval and mar ket ing of the new for mu la tion. Flamel also
men tioned that it had the po ten tial to earn more than $100 mil lion of mile stones and would re ceive roy al -
ties. The move rep re sented an at tempt by TAP to plug the hem or rhage in sales seen for Prevacid in the
USA.
Clin i cal Data: In 2003, the first head-to-head study of the five cur rently mar keted PPIs was pub lished in
the Amer i can Jour nal of Gastroenterology. Nexium con trolled intragastric acid ity to a greater ex tent than
the other four, de spite all the prod ucts shar ing the same mode of ac tion. In the ran dom ized, open-la bel
cross over trial, pa tients took each prod uct for five days, 30 min utes af ter a stan dard ized break fast. The
study com pared Nexium, Prevacid, Prilosec (omeprazole), Protonix (pantoprazole) and Aciphex
(rabeprazole).
In an open-la bel, US multicenter study, 87 ad o les cent pa tients with symp tom atic GERD were as signed to
re ceive ei ther Prevacid 15 mg or 30 mg once daily. Most pa tients had mild or mod er ate GERD symp toms.
Sixty-four pa tients had nonerosive GERD and were treated with Prevacid 15 mg daily for eight weeks,
while 23 pa tients had ero sive esophagitis and were treated with Prevacid 30 mg daily for eight to twelve
weeks. Prevacid was found to be safe and ef fec tive in treat ing pa tients with ero sive esophagitis and
symp tom atic GERD. Of 22 pa tients with ero sive esophagitis, 95.5% were healed af ter eight weeks of
treat ment, which is sim i lar to heal ing rates in adult studies.
Com pe ti tion: The world PPI mar ket is ex tremely com pet i tive, with many prod ucts fight ing for a mar ket
share. In the 12-month pe riod to the end of Sep tem ber 2008, ac cord ing to IMS, lansoprazole, sold as
Takepron, was the world’s sec ond lead ing antiulcerant with a 14.4% mar ket share and a 3% de cline in
dol lar growth. The num ber one prod uct in this area with 25.5% of the mar ket and 8% dol lar growth is
AstraZeneca’s Nexium, its fol low on prod uct to Losec (omeprazole), sales of which fell by 16% and
hold ing sixth place with 3.6% of the mar ket. Pariet (rabeprazole) took third place with 7.5% share.
Pantozol (pantoprazole) took fourth place 6% share and sales down 2% while Wyeth/Altana’s Protonix
(pantoprazole) took fifth place in the same pe riod with 3.8% of the mar ket, down 54% over the previous
year.
In 2007, the FDA cleared prilosec and Nexium of links to heart prob lems but dis closed a re view of po ten -
tial links for hip frac tures fol low ing a pre vi ous re port from JAMA sug gest ing that long term use of pro ton
pump in hib i tors can in crease hip frac ture risk in adults over 50.
Fol low ing the with drawal of Merck & Co’s Vioxx in 2004, sales of heart burn drugs such as Prevacid or
AstraZeneca’s Prilosec, in com bi na tion with OTC NSAIDS have gone up; re sults of a study re leased 2007
sug gest that this com bi na tion is as ef fec tive as us ing a COX-2 in hib i tors for re duc ing the risk of NSAID
gastropathy.
Procter & Gam ble (USA) launched Prilosec OTC in the USA in 2003. In 2004, Bentley Pharmaceuticals
(USA) was granted ap proval by the Span ish Health Min is try to mar ket a ge neric ver sion of lansoprazole in
Spain and then an nounced a launch in France in 2007. Takeda al ready mar kets its branded ver sion in the
coun try un der var i ous trade marks by a num ber of com pa nies in clud ing Merck & Co.
Sales/An a lyst Com ment: In the year to March 31 2008, ac cord ing to Takeda, do mes tic sales of
Takepron were Yen64.8 bil lion, up 11.8%. To tal global sales were up 8.2% to Yen148.7 bil lion. In the
12-month pe riod to the end of Sep tem ber 2008, lansoprazole (Takepron) was Takeda’s lead ing in ter na -
tional phar ma ceu ti cal prod uct, with 32.1% of cor po rate sales, down 3% (fixed dol lar rate) ac cord ing to
IMS. Mor gan Stan ley an a lysts (Au gust 2008), fore cast peak con sol i dated sales of Yen301.1 bil lion in the
next fis cal (end ing March 2009) and a grad ual de cline there af ter to Yen224 billion in the year to March
2012.
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