Furiex Pharmaceuticals, Inc. announced that its partner Takeda Pharmaceutical Company Limited (TKPYY) has received approval from the European Commission (EC) for Vipidia (alogliptin), Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone) for the treatment of type II diabetes.
Approval was in-line with expectations as the Committee for Medicinal Products for Human Use had rendered a positive opinion on these drugs on Jul 26, 2013.
The approval will provide Furiex $10 million as a milestone payment under its agreement with Takeda. Furiex will also receive tiered royalties on the sales of these products in the EU and other sales-based milestones.
Approval was granted on the basis of data from the ENDURE study Endure and interim data from the EXAMINE study.
It was observed from the ENDURE study data that a dosage of Vipidia 25 mg plus metformin showed superior durability of glycemic control at two years with lower hypoglycemic events and no negative effect on weight compared to a sulphonylurea (glipizide). The results also showed that the same dosage helped more patients to achieve target hemoglobin A1c (HbA1c) of ≤ 7% compared with a sulphonylurea in combination with metformin.
Meanwhile, results from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes study showed that Vipidia met the primary endpoint of non-inferiority to placebo plus standard of care. No increase in CV risk in a type II diabetes patient population at high-risk for CV events was observed.
Vipidia, Vipdomet and Incresync are already available in the U.S. from Jun 2013 under the brand names Nesina, Kazano and Oseni, respectively.
Furiex carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals (JAZZ - Analyst Report), with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.