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POZEN reports net loss of $6.9M for year ended December 31, 2009

October 20, 2017

The NDA for VIMOVO?? was submitted on June 30, 2009 and is under review by the U.S. Food and Drug Administration (FDA). We expect a response from the FDA in second quarter 2010. Pursuant to the collaboration agreement, POZEN received a $10.0 million milestone payment from AstraZeneca in September 2009. Results from the pivotal trials for VIMOVO were presented at the American College of Rheumatology Scientific Session in Philadelphia on October 19, 2009. AstraZeneca submitted a Marketing Authorization Application (MAA) to the European Union via the Decentralized Procedure for VIMOVO in October 2009.

PA Program

POZEN is creating a safer form of aspirin franchise of product candidates ?? the PA product platform. The first candidate, PA32540, is a coordinated-delivery tablet combining immediate-release omeprazole, a PPI, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and is under investigation for use for the secondary prevention of cardiovascular disease. The Company initiated the two Phase 3 pivotal trials for PA32540 in October 2009, in addition to a one year long safety study. The primary endpoint for the pivotal trials is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin.

An estimated 80 million U.S. adults have some form of cardiovascular disease, and the disease remains the #1 cause of death for men and women alike. PA32540 is being developed to deliver the cardio-protective benefits of aspirin while reducing the GI toxicity. If approved, it will offer a new therapeutic option to patients with cardiovascular disease and to doctors who treat them.

The POZEN PA pipeline also includes earlier-stage work evaluating the application of aspirin combinations for pain and pain-related conditions. POZEN is advancing commercialization plans for the PA franchise within the U.S. For markets outside the U.S., the company plans to seek strong global commercial partners.

Financial Guidance

POZEN will earn a $20.0 million milestone payment upon the U.S. Food and Drug Administration (FDA) approval of VIMOVO and will start to earn royalty revenue when AstraZeneca begins commercial sales. We will look to provide financial guidance on the 2010 year when we can determine the timing of these important events.

Source POZEN Inc.,