Two forms of Pozen’s experimental heart drug, PA8140 and PA32540, were rejected for the second time by FDA. The drugs are indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
In its latest complete response letter, the agency cited deficiencies during an inspection of the foreign manufacturing plant of an active ingredient supplier on April 25. Pozen stated that no clinical or safety deficiencies were reported about PA8140 and PA32540, to be marketed as Yosprala.
FDA regulations allow the company to request a meeting to discuss the next steps required to gain approval. John R. Plachetka, Pozen’s president and CEO, said he intends to request that meeting as soon as possible.
“Based on inspections at the site by an expert consultant we retained and our review of all relevant documents and communications with the supplier’s personnel, we believe that the FDA issues raised during the April inspection have been adequately addressed. So, our goal continues to be to do everything we can to assist the FDA compliance division with their review and to encourage them to move to completion of their review as soon as possible since this remains the only outstanding issue,” said Plachetka.
News of the rejection had Pozen's shares down 15% to $7.63 by press time.
The FDA snub comes two weeks after Sanofi terminated its partnership with Pozen on commercializing PA8140 and PA32540. The deal, inked in 2013, was worth up to $35 million.