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Furiex Confirms Takeda’s Receipt Of FDA Approval Of NESINA (alogliptin) And Fixed-Dose Combinations OSENI (alogliptin And Pioglitazone) And KAZANO (alogliptin And Metformin HCl) For The Treatment Of Type 2 Diabetes
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Pharmaceutical Company Limited has received approval from the U.S. Food and Drug Administration of three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.
Under its agreement with Takeda, Furiex is entitled to receive a $25 million milestone payment as a result of this approval, as well as royalties on sales in the United States and potential sales-based milestones. Furiex has already been receiving royalty payments from Takeda for the sale of NESINA and LIOVEL in Japan.
“Receiving regulatory approvals for NESINA, OSENI and KAZANO in the U.S. marks an important milestone for Furiex,” said Fred Eshelman, Pharm.D., chairman of Furiex. “These approvals should enable Takeda to build on the success of NESINA in Japan and leverage its more than 20 years of clinical and patient experience in the type 2 diabetes therapeutic area.”
“We are pleased to see these important therapies become available for patients with type 2 diabetes,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “Type 2 diabetes is a complex disease, requiring careful long-term disease management. We believe these new treatments in the U.S. offer patients additional therapeutic options for managing the disease.”
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $471 billion in 2012. By 2030, this number is projected to exceed $595 billion. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. Because of the chronic nature of this disease, combination therapy is often required to maintain diabetic control over many years of therapy.