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POZEN Reports PA65020 Significantly Reduces the Incidence of Upper GI Damage in Healthy Adults
Promising Results in Phase 1 Study

CHAPEL HILL, N.C., May 06, 2010 (BUSINESS WIRE) --POZEN Inc. (NASDAQ: POZN) today announced that results of a Phase 1 Trial of PA65020, a combination of enteric-coated aspirin (EC-ASA) and immediate-release (IR) omeprazole, show PA65020 significantly reduces the incidence of gastrointestinal (GI) mucosal damage compared to EC-ASA (650 mg twice daily) in healthy adults treated for one month. Patients receiving analgesic doses of EC-ASA were five times more likely to experience significant GI mucosal damage than patients receiving PA65020. The study concluded that PA65020 may provide an important therapeutic option for at-risk patients who require analgesic doses of aspirin. Data will be presented on May 7th at the 29th Annual Scientific Meeting of the American Pain Society (APS) in Baltimore, MD, being held May 6-8. Data will also be included in a supplemental issue of the Journal of Pain.

The benefits of aspirin are well-documented and more than five billion units of aspirin in all of its forms are sold in the U.S. each year. But because aspirin is linked with significant GI damage, it may be underutilized for both secondary prevention of cardiovascular disease as well as pain. "We are pleased to report that PA65020 reduces the incidence of upper GI damage compared to aspirin therapy," said Dr. John Fort, Chief Medical Officer, POZEN. "These results are promising for the millions of people who could benefit from analgesic doses of aspirin therapy, but are at risk for upper GI damage from this treatment."

About the Study

The study examined 40 healthy adults with normal gastroduodenal endoscopy, defined as a Grade 0 Lanza score, at baseline. Dosing schedules were as follows: PA65020 (fixed dose combination of EC-ASA 325 mg and IR omeprazole 20 mg, and EC-ASA 325 mg) was administered as two tablets twice daily; EC-ASA 650 mg was administered as two 325 mg tablets twice daily. On day 28 of therapy, 15% of the PA65020 treatment group versus 85% of the EC-ASA treatment group had Grade 3 or 4 Lanza scores (P<0.001), the study's primary endpoint. In addition, 65% of subjects in the PA65020 group had Grade 0 Lanza scores, meaning no visible gastroduodenal lesions, versus 0% of subjects in the EC-ASA group. In addition, no patients in the PA65020 treatment group developed a gastric/duodenal ulcer versus 8 patients (40%) of those in the EC-ASA treatment group (P=0.003) at day 28. No serious adverse events were reported and there were no withdrawals due to adverse events in either treatment arm.

About PA65020

PA65020 is part of the PA franchise under development by POZEN. The PA products utilize a patented technology, developed by POZEN, which allows for sequential release of the active components and protects the stomach in advance of the release of the gastric offending agent. This same proven technology is the basis for VIMOVO(TM), (naproxen and esomeprazole magnesium) delayed-release tablets, approved by the Food and Drug Administration (FDA) on April 30, 2010 for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of gastric ulcers in patients at risk of developing non-steroidal anti-inflammatory drug (NSAID) associated ulcers. VIMOVO is co-developed by POZEN and AstraZeneca. POZEN's safer form of aspirin, the PA franchise, has the potential to expand the use of aspirin by significantly improving the tolerability and reducing the risk of GI toxicity issues associated with aspirin therapy.


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 their 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:

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, and our dependence on AstraZeneca for the sales and marketing of VIMOVO; 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 March 31, 2010. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.


Bill Hodges, Chief Financial Officer

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