Pozen gains on regulatory update

Pozen Inc. (NASDAQ:POZN) gained $0.42 to $6.72 on Friday after providing an update on its regulatory plans for PA32540 and the lower dose formulation, PA8140, following a meeting with FDA. The company now plans to submit a combined NDA for both products in 1H13 for the secondary prevention of cardiovascular disease in patients at risk for gastric ulcers. Pozen was planning to submit a single application for PA32540 in 3Q12, but in May FDA told the company the application should include the lower dose. PA32540 is a tablet containing 325 mg aspirin surrounded by an immediate-release coating of 40 mg omeprazole, a proton pump inhibitor (PPI). PA8140 contains 81 mg aspirin and 40 mg omeprazole.

The company plans to conduct a pharmacokinetic study of PA8140 to show bioequivalence to enteric-coated (EC) 81 mg aspirin and possibly a Phase I trial. FDA is not requiring a Phase III trial for PA8140. ...