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POZEN'S MT 100 Meets Primary Endpoint in Final Phase III Trial

CHAPEL HILL, N.C., Feb. 21 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, announced that the final Phase III clinical trial for MT 100, the company's first-line treatment for migraine, has been successfully completed. According to the MT 100-304 data, MT 100 was statistically superior to both its components for sustained pain relief, the trial's primary endpoint.

"MT-100 has met or exceeded our expectations throughout the entire clinical trials program. We believe we have now satisfied all the Phase III clinical requirements requested by the Food and Drug Administration (FDA) for MT 100," said John R. Plachetka, Pharm. D., POZEN's chairman, president and chief executive officer. "The MT 100-304 data, obtained from over 2,500 patients, confirm results from the MT 100-301 study indicating that the product is more effective than its components. Over the course of four Phase III comparative trials, we have consistently shown that MT 100 provides significant relief versus placebo for migraine headache pain and all the associated symptoms of migraine, including nausea, sensitivity to light and sensitivity to sound."

North Carolina-based POZEN Inc. is a pharmaceutical development company committed to building a portfolio of products with significant commercial potential in select therapeutic areas. The company's initial focus is migraine, where it has built a robust portfolio of four product candidates through a combination of innovation and in-licensing. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN."

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 MT 100 and our other products; costs and delays in the development of MT 100 and our other products; our inability to enter into or maintain, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of our products; 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 our 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 Registration Statement filed on Form S-1 (File No. 333-35930) under "Business" or " Risk Factors." We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

POZEN is on the Internet at SOURCE POZEN, Inc.

Matt Czajkowski
Chief Financial Officer, of POZEN
General Inquiries
Kathy Brunson of FRB Weber Shandwick

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