|POZEN Announces PN 200 Podium Presentation at Digestive Disease Week|
|CHAPEL HILL, N.C., May 19, 2008 (BUSINESS WIRE) -- POZEN Inc. (NASDAQ:POZN), today announced that Dr. Jay Goldstein,
Professor of Medicine with the Department of Medicine, University of
Illinois at Chicago and lead presenter for a PN 200 concept trial
(immediate release omeprazole 20 mg, and enteric coated naproxen 500
mg), gave a podium presentation on the PN 200 study results at
Digestive Disease Week on May 18, 2008.
PN 200 was a 400 patient concept trial conducted by POZEN. Approximately 200 subjects each received PN 200 or enteric coated naproxen 500 mg, twice a day, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. The primary endpoint was the cumulative incidence of gastric ulcers. The study results indicated significantly fewer endoscopically confirmed gastric ulcers in subjects on PN 200 compared to subjects receiving enteric coated naproxen (8.3% v. 29.4%, pless than0.001) during the six-month period.
POZEN and AstraZeneca entered into a co-development agreement for PN 400 (immediate release esomeprazole 20 mg, and enteric coated naproxen 500 mg) in August 2006. PN 400 is an investigational product under clinical development in patients who require chronic non-steroidal anti-inflammation drugs (NSAIDs) treatment for arthritis pain, such as osteoarthritis and who are at risk for NSAID-associated gastric ulcers. The PN 400 pivotal trials, which are similar in design to the PN 200 study reported above, are now fully enrolled and are expected to be completed by the end of 2008 with an NDA filing anticipated in the first half of 2009.
Dr. John R. Plachetka, chairman, president and chief executive officer stated, "The PN 200 concept trial demonstrated a significant reduction in gastric ulcers over enteric coated naproxen and validates previous findings from our proof-of-concept studies using Lanza scores. We look forward to completion of the PN 400 trials using esomeprazole in the formulation."
Osteoarthritis is one of the most frequent causes of physical disability among adults, affecting an estimated 20 to 30 million people in the United States. Estimates from the National Institutes of Health show that by 2030, 20 percent of Americans--about 70 million people--will have passed their 65th birthday and will be at risk to develop osteoarthritis.
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(TM), which was recently 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; 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 March 31, 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