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Furiex Confirms Takeda's Resubmissions of Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone NDAs to FDA


Furiex Pharmaceuticals (NASDAQ: FURX) confirmed Friday that Takeda Pharmaceutical announced that its wholly-owned subsidiary, Takeda Global Research & Development Center has resubmitted New Drug Applications to the U.S. Food and Drug Administration for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults. Takeda anticipates the applications will be reviewed within the next six months. These NDAs were resubmitted in response to a complete response letter Takeda received from the FDA on April 25, 2012.

These 2012 resubmissions include additional data from three phase III clinical trials involving more than 3,275 patients conducted at 1,384 centers worldwide. When combined with previously submitted phase III clinical data, which included more than 8,000 patients conducted in more than 1,000 centers worldwide, nearly 10,000 patients have been treated with alogliptin in the clinical development programs to date.

Under Furiex's agreement with Takeda, Furiex is eligible to receive a $25 million milestone payment for the approval of the first of these two NDAs, as well as potential royalties and sales-based milestones. Furiex currently receives royalty payments from Takeda for the sale of these alogliptin products in Japan, trade names NESINA® and LIOVEL®.

Posted-In: News FDA After-Hours Center


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