Takeda resubmits alogliptin and fixed-dose combination therapy NDAs with FDA

Jul 28 2012

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. has resubmitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) 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®.

"We are pleased Takeda has taken this important step of resubmitting the alogliptin NDA. These resubmissions are significant advancement towards regulatory approval of the alogliptin monotherapy," said Fred Eshelman, Pharm.D., chairman of Furiex.

Added June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, "From the onset we have believed in the potential of alogliptin, if approved, to contribute to improving the health of diabetes patients, and these NDA resubmissions are important steps in expanding these treatment options to a wider patient population."