IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
down hor mone glucagon-like pep tide 1 and its in hi bi tion re sults in in creased GLP-1 lev els which stim u late
pan cre atic in su lin pro duc tion and sup presses glucagon pro duc tion and may help to re store beta is let cell
func tion and lost in su lin pro duc tion. This new class is ex pected to be ther a peu ti cally im por tant due to a
ben e fi cial side ef fect pro file over ex ist ing therapies which result in weight gain and edema.
Li cens ing: In 2003, Syrrx signed an agree ment with PPD (USA) to jointly de velop DPP-IV in hib i tors. In
2005, Takeda ac quired Syrrx (to form Takeda San Diego), gain ing SYR 322 in the pro cess. In July 2005,
Takeda and PPD ter mi nated the pre vi ous col lab o ra tion, and signed an agree ment grant ing Takeda de vel -
op ment and mar ket ing rights to DPP-IV in hib i tors, in clud ing SYR 322. PPD is now the sole pro vider of
phase II/III de vel op ment ser vices to Takeda in the US and Europe.
Clin i cal Data: The ap proval sub mis sion was based on re sults from six phase III tri als in volv ing over
2000 pa tients. Dur ing these stud ies, alogliptin was ad min is tered as a once-daily monotherapy ad junct to
diet and ex er cise and as add-on ther apy to other antidiabetic agents. Re sults showed that
alogliptin-treated pa tients had sta tis ti cally sig nif i cant re duc tions in he mo glo bin A1c (re flect ing av er age
blood glu cose con cen tra tions over the pre vi ous two to three months). The agent was gen er ally well tol er -
ated and weight-neu tral. No in crease in hypoglycemia was observed compared with placebo.
Lifecycle Man age ment: Takeda has been con duct ing phase III tri als of pioglitazone in com bi na tion
with the DPP-4 in hib i tor SYR-322 in the US and Eu rope and in Sep tem ber 2008 filed an NDA for a
fixed-dose com bi na tion drug. Ap proval is ex pected no ear lier than mid-2009. The fil ing was sup ported by
data from two phase III stud ies in volv ing 2,000 pa tients world wide who did not achieve glycemic tar gets
with diet and ex er cise or metformin alone. The com bi na tion was re ported to sig nif i cantly im prove
glycemic con trol as well as pa ram e ters re lated to beta cell func tion/in su lin re sis tance and be gen er ally
well tol er ated. This com bi na tion was un der go ing phase III evaluation in Europe and phase I in Japan in
2009
Com pe ti tion: If ap proved, SYR 322 will be the sec ond DPP-IV in hib i tor af ter Merck & Co’s Januvia
(sitagliptin) which was the first to reach the US mar ket (in Oc to ber 2006) and is now the ‘gold stan dard’
for this class fol low ing a strong ini tial launch; it is now also avail able in the EU and in De cem ber 2007 be -
came the first to be filed for ap proval in Ja pan. In or der for newer DPP-IVs to com pete ef fec tively, they
must as a min i mum be as good as Januvia in terms of ef fi cacy and safety. Ad di tion ally, while it may be
pos si ble to have a sim i lar pro file to Januvia, it will not be easy to dem on strate su pe ri or ity. By the 12
months to Sep tem ber 2008, Januvia had al ready be come the world’s sec ond-ranked oral antidiabetic
(A10B class), ac cord ing to IMS, with 8.7% mar ket share. In first po si tion was Takeda’s glitazone Actos,
with a 28.1% share and 9% sales growth, with GSK’s Avandia down 52% to third place with 8.1% share
af ter a num ber of ques tions over the prod uct’s safety. There is a chance that the safety is sues for Avandia
and other antidiabetics could ben e fit Januvia, as the FDA is likely to re quire large, long-term safety stud -
ies, es pe cially to mon i tor car dio vas cu lar risks, thus pos si bly de lay ing the ar rival of new com pet i tors. An
FDA ad vi sory panel voted in fa vor of such a move in July 2008. In April 2008, both glitazones were linked
to an in creased risk of bone frac tures. While many phy si cians are likely to stick with tried-and-tested
metformin, some may opt to pre scribe Januvia in stead of a glitazone in pa tients who re quire fur ther blood
sugar con trol. Al though Takeda will face stiff com pe ti tion, the prod uct will en force Takeda’s antidiabetic
strong hold with Actos with and with out metformin, acarbose and mitiglinide. An a lysts so far seem to be
of the opin ion that alogliptin only of fers sim i lar safety and ef fi cacy to Januvia, though ac knowl edge that
Takeda does have greater ex pe ri ence in di a be tes, and is also await ing ap proval of a pill com bin ing
alogliptin with its lead ing glitazone, Actos (pioglitazone), expected in the second half of 2009.
Januvia’s main com pet i tor is ex pected to be Novartis’ Galvus (vildagliptin), which was launched in June
2007 in Brazil and Mex ico, and was ap proved in all 27 EU mem ber states as well as Nor way and Ice land in
Sep tem ber 2007. How ever, the EU launch is likely to be de layed un til Novartis has re solved the liver
safety prob lems as so ci ated with high doses of the drug. In No vem ber 2007, Novartis pro vided the Eu ro -
pean reg u la tors with data that showed liver en zyme el e va tions were less fre quent in pa tients tak ing the
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