|POZEN Demonstrates Bioequivalence to Enteric Coated Aspirin for PA32540|
Company Announces Filing of Special Protocol Assessment for
CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 9, 2008--POZEN Inc. (NASDAQ:POZN), today announced that is has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for its pivotal Phase 3 trials for PA32540. The company had previously met with the FDA to discuss the overall development program requirements.
As part of the SPA submission, the company has provided data indicating that PA32540 is bioequivalent to 325mg enteric coated aspirin. By demonstrating bioequivalence to enteric coated aspirin, we believe PA32540, if approved, will receive all of aspirin's claims for the secondary prevention of cardiovascular events, such as heart attacks and strokes.
Dr. Marshall E. Reese, executive vice president, product development stated, "All aspects of the PA program are on target, and we expect to be in a position to begin the Phase 3 trials after we finalize the SPA with the FDA, which we anticipate will be during the third quarter of 2008."
PA32540, a patented investigational product containing aspirin 325mg and omeprazole 40mg in a unique dosage form, is designed to deliver the cardiovascular benefits of aspirin with a lower incidence of gastric ulcers than enteric coated aspirin.
About Cardiovascular Disease and Stroke
Nearly 2,400 Americans die of cardiovascular disease each day--an average of one death every 37 seconds. In 2008, an estimated 770,000 Americans will have a new coronary attack, and about 430,000 will have a recurrent attack.
Each year, about 780,000 people experience a new or recurrent stroke.
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.
CONTACT: POZEN Inc. Bill Hodges, Chief Financial Officer, 919-913-1030 or Fran Barsky, Director, Investor Relations, 919-913-1044 SOURCE: POZEN Inc.