IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Alimentary Tract and Metabolism Agents
drug delivery system, modified release
dexlansoprazole TAK 390MR A2B2 Approved
alogliptin benzoate SYR 322 A10N1 Filed
pioglitazone + metformin extendedrelease
— A10K3 Filed
cetilistat ATL 962 A8A III
ilaprazole IY 81149 A2B2 III
repaglinide — A10B9 III
vedolizumab MLN 0002 A7E III
ddp-iv inhibitor SYR 472 A10N1 II
insulin sensitizer TAK 379 A10X II
insulin sensitizer TAK 875 A10X II
ddp-iv inhibitor TAK 100 A10N1 I
inflammatory disease therapy MLN 0415 A7E, R3X, N7X I
potassium-competitive acid blocker (oral) TAK 438 A2B2 I
Crohn’s disease therapy MLN 3126 A7E Preclinical
TAK 390MR is a mod i fied-re lease for mu la tion of an en an tio mer of the pro ton pump in hib i tor
dexlansoprazole, for the treat ment of gastroenterological acid-re lated dis or ders. In late Jan u ary 2009,
one year af ter fil ing, Takeda an nounced that the FDA ap proved TAK 390MR for the treat ment of acid-re -
lated dis eases and treat ment and main te nance of pa tients with ero sive esophagitis and non-ero sive re -
flux dis ease. Kapidex is po si tioned as a suc ces sor to Prevacid which goes off pat ent in No vem ber 2009.
The TAP jv concluded in May 2008.
The prod uct en tered phase II tri als in Ja pan in 2007 and in May 2008, fa vor able late-stage trial re sults
were re ported show ing that it was more ef fec tive than Prevacid in heal ing in flam ma tion of the esoph a -
gus; these tri als were ongoing in 2009.
Li cens ing: The com pound is li censed to TAP for de vel op ment in North Amer ica and if suc cess ful, could
cush ion the ex pected huge loss to the com pany’s prof its when Prevacid’s pat ent ex pires in 2009. The new
prod uct will com pete with AstraZeneca’s Nexium, the suc ces sor to Prilosec.
Clin i cal Data: The NDA fil ing in Jan u ary 2008 was based on stud ies which eval u ated over 6000 sub jects
in more than 20 coun tries. In Au gust 2005, TAP ini ti ated phase III tri als to eval u ate TAK 390MR in more
than 5,000 pa tients with gastroenterological acid-re lated dis or ders in the USA. The FDA al lowed phase II
tri als to be skipped as the mo lec u lar struc ture of the mol e cules are a mir ror im age (enantiomer) of
Prevacid.
Sales/An a lyst Com ment: An a lysts at Mor gan Stan ley writ ing in Au gust 2008 fore cast sales of Yen21
bil lion in the next fis cal (end ing March 2009) ris ing to Yen210 bil lion by the year end ing March 2013.
SYR 322, an oral dipeptidyl peptidase IV (DPP-IV) in hib i tor was filed for US ap proval in De cem ber 2007
for the treat ment of type II di a be tes, two years af ter en ter ing a global (mainly US and Ja pan) phase III
trial which com menced just four years fol low ing first lab tests; Takeda has not re vealed the ex act in di ca -
tions sought for the prod uct. Alogliptin is ex pected to be come a new main stay for Takeda and US ap -
proval is ex pected in June 2009, a de lay of eight months from the orig i nal date al though no is sues have
been raised and this is due to con straints within the FDA. In Sep tem ber 2008, Takeda filed for ap proval of
alogliptin in Ja pan. Al though no phase III stud ies have been con ducted in Ja pan, the fil ing is based on re -
sults of phase III and ear lier stud ies abroad. Re sults of these over all show that alogliptin sig nif i cantly re -
duces HbA1c safely and with good tolerability. Phase III trials were underway in Europe in 2009.
The agent was gen er ated by Syrxx (now part of Takeda) from a pro gram ini ti ated in 2002, to dis cover
DPP-IV in hib i tors, af ter de ter mi na tion of the struc ture of DPP-IV. DPP-IV is an en zyme which breaks
© 2009 IMS Health In cor po rated or its af fil i ates Page 58