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."
Source: Furiex Pharmaceuticals, Inc.