Last week, POZEN announced that the company had received a complete response letter for its drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets after the FDA after an inspection of one of POZEN’s manufacturing facilities.
The FDA informed the company that an inspection of a 3rd party supplier’s manufacturing facility found inspection deficiencies. The supplier provided the active ingredient for POZEN’s drug candidates, PA8140 and PA32540. Because of the problems at supplier’s manufacturing plant, POZEN’s new drug application was denied. POZEN will have to resolve all issues covered in the letter before its new drug application will be considered again by the FDA.
POZEN has stated that these manufacturing deficiencies can and will be resolved by working with the manufacturer. There were no other serious clinical or safety deficiencies found by the FDA.
John R. Plachetka, chairman, president, and CEO of POZEN, said that the company was disappointed but believed that the issues would ultimately be resolved in a timely manner. “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. 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,” said Plachetka. “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. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8th.”