POZEN Announces Positive Top Line Results for Its PN 400 Phase 3 Trials
PN 400 Demonstrated Statistically Significant Fewer Gastric Ulcers vs. Enteric Coated Naproxen
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec 3, 2008 - POZEN Inc. (NASDAQ: POZN), today announced positive Phase 3 trial results for its PN 400 product candidate (enteric coated naproxen 500 mg and immediate release esomeprazole 20 mg) conducted by POZEN under an agreed Special Protocol Assessment with the FDA.
Both the PN 400-301/302 studies achieved the primary endpoints. Subjects taking PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers on PN 400 compared to subjects receiving enteric coated naproxen during the six-month period. In each of the trials, approximately 400 subjects received either PN 400 or enteric coated naproxen 500 mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months with the primary endpoint as the cumulative incidence of gastric ulcers. The FDA has recently informed POZEN that the appropriateness of this endpoint is the subject of an internal review and an FDA internal meeting is planned in Q1 2009 to discuss this matter.
POZEN and AstraZeneca entered into a co-development agreement for PN 400 in August 2006. PN 400 is an investigational product under clinical development in patients who require chronic non-steroidal anti-inflammation drug (NSAID) treatment for arthritis pain, such as osteoarthritis and who are at risk for developing NSAID-associated gastric ulcers. The NDA submission is planned for mid-2009. Full results of the PN 400 Phase 3 studies will be published in a timely manner.
Osteoarthritis is one of the most frequent causes of physical disability among adults. An estimated 46 million adults in the U.S. have physician diagnosed arthritis, accounting for 21 percent of the U.S. adult population, and two thirds of the people that have doctor-diagnosed arthritis are under the age of 65. Fifty percent of people on chronic NSAID's are at risk for developing NSAID-associated gastric ulcers.
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®, 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.
Bill Hodges, Chief Financial Officer
Fran Barsky, Director, Investor Relations
Posted: December 2008