Takeda's MAA Filing Triggers a $10-Million Milestone

Furiex Pharmaceuticals, Inc. recently confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.

Under Furiex’s agreement with Takeda, this acceptance triggers a $10-million milestone payment to Furiex. Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names NESINA and LIOVEL in Japan, and it will receive royalties on sales in Europe, if approved.

“The acceptance of the MAA submission for alogliptin is an important step in expanding this treatment option to a wider patient population,” said June Almenoff, MD, PhD, President and Chief Medical Officer of Furiex.

“From the onset, we have believed in the value of alogliptin to patients, and we are pleased with this achievement,” added Fred Eshelman, PharmD, Chairman of Furiex,

Alogliptin is a DPP-4 inhibitor being investigated in the US, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA in this market.

Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Its drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates, including two Phase III-ready assets, one compound in Phase III development with a partner, and two products on the market. The company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.