POZEN Informed by FDA That Endoscopic Gastric Ulcer Incidence Continues to Be an Acceptable Primary Endpoint
Posted: 01-29-2009 : CHAPEL HILL, N.C.

CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ: POZN) announced today that the U.S. Food and Drug Administration (FDA) has completed its internal discussions and informed the Company that there is no change to previous agreements that gastric ulcer incidence is an acceptable primary endpoint for POZEN’s clinical programs. In October 2008, the FDA had informed POZEN during its review of both the Special Protocol Assessment (SPA) for PA32540 and the Statistical Analysis Plan (SAP) for PN 400 that the FDA was conducting an internal review on the acceptability of gastric ulcers as a primary endpoint in clinical studies.

PN 400, an investigational product under development by POZEN and AstraZeneca, is a fixed dose combination of enteric-coated naproxen with immediate release esomeprazole for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID associated gastric ulcers. The two pivotal ulcer risk reduction studies have been completed and met their primary endpoints. In both studies, patients taking PN 400 experienced significantly fewer endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated naproxen during the six-month treatment period. The NDA submission is planned for mid-2009.

PA32540, a patented investigational product containing aspirin (325 mg) and omeprazole (40 mg) in a unique dosage form under development by POZEN, is designed to deliver the cardiovascular benefits of aspirin with a lower incidence of gastric ulcers than enteric-coated aspirin. POZEN requested an SPA from the FDA for the design of the PA32540 Phase 3 clinical studies. The proposed primary endpoint was the reduction in the incidence of endoscopic gastric ulcers. With the FDA’s determination that endoscopic gastric ulcer incidence continues to be an acceptable endpoint, POZEN will seek to finalize the SPA for PA32540.

About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was recently approved by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The Company’s common stock is traded on The Nasdaq Stock Market under the symbol “POZN”. For detailed company information, including copies of this and other press releases, see POZEN’s website: www.pozen.com.