Pozen shares fell more than 10 percent Monday after the Chapel Hill company announced that federal regulators have informed the company that its new drug application cannot be approved in its current form.
The application is for Pozen's drug PA, which is designed to reduce aspirin-induced gastric ulcers and associated internal bleeding. The medication combines coated aspirin and omeprazole.
In its letter to Pozen, the Food and Drug Administration said that inspection deficiencies were found during an inspection of a manufacturing facility that is an active ingredient supplier. Pozen said it believes the deficiencies can be addressed and will be working with the manufacturer to respond to the FDA concerns as soon as possible.
“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,” CEO John Plachetka said in a statement.
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The FDA was scheduled to issue a final ruling on Pozen’s application on Friday.
Pozen has a licensing agreement with Sanofi to commercialize PA that could earn the company as much as $35 million in payments.