Pozen (POZN) shares dropped on news that the FDA has accepted for review the refiling of a NDA for two aspirin candidates, PA8140 and -32540. During an audit of POZEN’s manufacturing facility, FDA discovered problems with production of an active ingredient, which was noted in the Complete Response Letter (CRL) on April 25, 2014. The resubmission of the NDA will be treated as Class 2, with a new user fee goal date of December 30, 2014.
Pozen’s weakness on the news is a result of the 6-month timeline until the PDUFA decision for the omeprazole/aspirin combination, which is standard for a Class 2 resubmission. Many investors had been optimistic about a Class 1 resubmission, which would have put the PDUFA late in the third quarter.
This follows closely on news that Pozen CEO John R. Plachetka sold 33,551 shares of stock on July 8th for an average price of $8.87.
The PA platform is being developed to reduce GI ulcers and other gastrointestinal issues compared to enteric-coated or plain aspirin. PA8140 and -32540 contain 81 and 325 mg delayed release aspirin, respectively, but combined with immediate-release omeprazole (40mg) – a proton pump inhibitor surrounding a pH-sensitive coating of an aspirin.
