Press Release

Printer Friendly Version View printer-friendly version
<< Back
POZEN'S PA32520 Study Data Demonstrated Better Upper Gastrointestinal Protection
PA32520 May Provide Better Cardiovascular Protection Than 81 mg Enteric Coated Aspirin
CHAPEL HILL, N.C., Nov 11, 2008 (BUSINESS WIRE) -- POZEN Inc.'s (NASDAQ:POZN) PA32520 product candidate (enteric coated aspirin 325 mg with immediate release omeprazole 20 mg) may provide less upper gastrointestinal mucosal damage usually associated with higher doses of aspirin therapy, and may allow for treatment with higher doses of aspirin (up to 325 mg/daily) to maximize cardiovascular protection, according to new data presented today at the American Heart Association's (AHA) Scientific Sessions 2008 in New Orleans, Louisiana. Findings from two similar studies, which included 160 subjects, showed that treatment with enteric coated aspirin alone is associated with a high prevalence of upper gastrointestinal damage. This damage is reduced with PA32520 therapy as referenced in the study abstract.

An estimated 50 million Americans take low-dose aspirin for cardiovascular protection. Upper gastrointestinal tolerability and safety concerns with aspirin have prompted physicians to recommend 81 mg aspirin. However, 81 mg aspirin for secondary cardiovascular prevention may not have equivalent antiplatelet effects to higher dose (325 mg) aspirin. Aspirin 325 mg, in combination with proton pump inhibitors, may provide a reduction in upper gastrointestinal damage and greater thromboxane suppression than 81 mg of aspirin alone. As stated in the AHA scientific abstract, compared to 81 mg of enteric coated aspirin, PA32520 produces superior inhibition of in vivo thromboxane generation and may provide an important option for patients requiring long-term aspirin therapy for cardiovascular protection.

"POZEN's PA32520, a novel combination of aspirin and omeprazole, may provide physicians with an improved therapeutic option for patients who require long-term aspirin therapy for cardiovascular protection. Additional large scale prospective studies will be required to confirm efficacy," said Dr. Paul A. Gurbel, Director, Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, Associate Professor of Medicine, Johns Hopkins University School of Medicine.

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(R), which was approved by the United States Food and Drug Administration for the acute treatment of migraine attacks; 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.

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, such as the current uncertainty regarding primary clinical endpoints for our PN and PA programs; 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, including the potential introduction of competing generic products; 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, 2008. 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.

POZEN Inc. 
Bill Hodges, Chief Financial Officer, 919-913-1030 or 
Fran Barsky, Director, Investor Relations, 919-913-1044

Replication or redistribution of EDGAR Online, Inc. content is expressly prohibited without the prior written consent of EDGAR Online, Inc. EDGAR Online, Inc. shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.