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<strong>IMS</strong> COM PANY PRO FILES TAKEDA<br />
zer land) Epogin (epoetin beta) which has been filed for ad di tional do mes tic ap proval in chemotherapy<br />
induced anemia.<br />
TAK 442, an orally ac tive, se lec tive and com pet i tive in hib i tor of ac ti vated fac tor Xa, as a po ten tial ther -<br />
apy for ve nous or ar te rial thromboembolism, such as pul mo nary em bo lism and ce re bral in farc tion.<br />
Takeda ini ti ated a US/Eu ro pean phase II trial of TAK 442 in 2008 and phase I eval u a tion was also re -<br />
ported to be underway in Japan in 2009.<br />
Cardiovascular System Agents<br />
azilsartan + pioglitazone — C9C III<br />
azilsartan medoxomil TAK 491 C9C III<br />
azilsartan TAK 536 C9C II<br />
epa/dha agent TAK 085 C10A9 II<br />
ARB for hypertension TAK 591 C9C I<br />
AZILSARTAN + PIOGLITAZONE, a fixed com bi na tion of pioglitazone, a thiazolidinedione, plus<br />
azilsartan, an an gio ten sin II re cep tor an tag o nist, for the po ten tial treat ment of Type 2 di a be tes as so ci -<br />
ated with hy per ten sion. A US phase III trial pro gram of the prod uct in pa tients with Type 2 di a be tes as so -<br />
ci ated with hy per ten sion began in the USA in 2006.<br />
TAK 491, an an gio ten sin II re cep tor an tag o nist with po ten tial in the treat ment of hy per ten sion was un -<br />
der go ing phase III eval u a tion in Eu rope and the USA in 2009. A ran dom ized, dou ble-blind, pla cebo-con -<br />
trolled phase II trial, be ing con ducted in the USA, Mex ico and Peru, eval u ated the safety, ef fi cacy and<br />
tolerability of treat ment with TAK 491 for eight weeks in ap prox i mately 420 pa tients with hy per ten sion.<br />
The pri mary endpoint was diastolic blood pressure.<br />
TAK 491 is ex pected to have a stron ger antihypertensive ac tion and to dis play a su pe rior pro file in im -<br />
prov ing in su lin re sis tance and de creas ing proteinuria com pared with mar keted an gio ten sin receptor<br />
blockers.<br />
TAK 536 (azilisartan) is an an gio ten sin II re cep tor an tag o nist, in phase II de vel op ment for the treat ment<br />
of hy per ten sion in the USA and Eu rope and also en tered phase II tri als in Ja pan in 2007, all re ported to be<br />
ongoing in 2009.<br />
In July 2006, Takeda be gan a phase III trial pro gram of a fixed com bi na tion of pioglitazone plus TAK 536<br />
for the treat ment of Type 2 di a be tes as so ci ated with hy per ten sion (see sep a rate drug record).<br />
OMACOR (TAK 085), omega-3-acid ethyl es ters, en tered phase II tri als for the treat ment of<br />
hyperlipidemia in Ja pan with Takeda in 2007, on go ing in 2009. In 2005, Takeda li censed the Jap a nese<br />
rights to Omacor (TAK 085) from Pronova.<br />
TAK 591, an an gio ten sin II re cep tor blocker was in phase I tri als for the treat ment of hy per ten sion in<br />
2009.<br />
© 2009 <strong>IMS</strong> Health In cor po rated or its af fil i ates Page 70