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Press Release

POZEN Announces Start of Enrollment For PA32540 Phase 3 Program

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Nov. 20, 2009-- POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.

“We believe that PA32540 could address the needs of certain patients with cardiovascular disease,” said John Fort, MD, Chief Medical Officer, POZEN. “We look forward to progressing the development of PA32540 through Phase 3 studies, enabling us to bring this potentially important advancement to those who need it.”

About the Studies

POZEN is conducting two pivotal phase 3 studies and one long-term safety study. The two Phase 3 pivotal trials will be conducted under a Special Protocol Assessment agreed with the Food and Drug Administration. These studies will involve over 100 sites, enrolling approximately 500 patients per study. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin.

The long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.


POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st Century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to our customers. The company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For more detailed company information, including copies of this and other press releases, please visit: www.POZEN.com.

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2009. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Source: POZEN Inc.

Bill Hodges, 919-913-1030
Chief Financial Officer