POZEN Plans to Submit Response to Approvable Letter For Trexima™
Posted: 10-05-2007 : CHAPEL HILL, N.C.

CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ: POZN) announced  that it plans to submit a response to the Approvable letter for Trexima received on August 1, 2007, within the next ten days. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter.

POZEN believes the submission will constitute a full response. The submission will include clarifying non-clinical information to further address the agency’s concern regarding the genotoxic potential of Trexima and, as required by FDA, a routine clinical safety update. The FDA may take up to six months to review this submission, although POZEN will request an expedited review. 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 the proposed product candidate Trexima™ combining sumatriptan, formulated with RT Technology™, and naproxen sodium in a single tablet which is currently under review by the United States Food and Drug Administration for the acute treatment of migraine, and with AstraZeneca for a proprietary fixed dose combination 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.