Takeda Pharmaceutical (TKPYY) recently announced the launch of three type II diabetes drugs in the US - Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride), and Oseni (alogliptin and pioglitazone).
Nesina, Kazano and Oseni received US Food and Drug Administration (:FDA) approval in Jan 2013. These drugs are to be used along with diet and exercise.
As per the FDA, type II diabetes affects roughly 24 million people, forming 90% of total diabetes patients in the US. The type II diabetes market is currently crowded with drugs like Januvia, Bydureon. Janumet, VIctoza and IDegLira
The FDA had asked for 5 post-marketing studies for Nesina, 2 for Kazano and 1 for Oseni. Kazano carries a boxed warning for lactic acidosis while Oseni carries a boxed warning for heart failure associated with pioglitazone use.
Nesina was launched in Japan in the year 2010. These three drugs are under review in the EU, where it was submitted in the second quarter of 2012. Takeda expects EU decision in the second half of 2013.
In 2005, Takeda acquired development and marketing rights to all dipeptidyl peptidase IV (DPP4) inhibitors from Furiex Pharmaceuticals, Inc. (FURX).
The 2013 financial guidance provided by Takeda in May 2013 includes the effect of this launch. For 2013, Takeda expects Net sales of 1590 billion yen and earnings per share of 120.34 yen.
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