Pozen, Inc. Crashes As FDA Rejects Two Forms Of Its Lead Drug Yosprala

December 17, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Pozen, Inc. , a North Carolina-based biopharmaceutical company, announced today that two of its investigational drug candidates have received a second complete response letter from the U.S. Food and Drug Administration. YOSPRALA 81/40 and 325/40 were addressed in the CRLs, which are sent when the FDA has reviewed a file but still has questions prior to the approval of a new drug application.

The most recent CRL reflected the initial one sent to the company approximately seven months ago, which stated that an FDA investigator found deficiencies during an inspection of a foreign manufacturing facility. Before the FDA can approve a new drug application, these deficiencies must be addresses.

There were no clinical or safety issues noted in the letters respect to the drugs, and no other problems were cited.

After the FDA investigator found issues back in April, the supplier created a plan of action to correct the deficiencies in May. There has been no new inspection of the facility, but Pozen has been updating the FDA on its progress and its plan of action.

“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,” said John Plachetka, chairman, president and chief executive officer of Pozen. “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.”

The FDA and Pozen have yet to agree on the draft product labeling for the drugs as well. YOSPRALA 81/40 and 325/40, which each contain an aspirin core, are designed as a form of secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA,” Plachetka said when the first CRL was issued. “The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised. We don’t want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA.”