|POZEN Statement on FDA Gastrointestinal Drugs Advisory Committee Meeting|
CHAPEL HILL, N.C., Nov 05, 2010 (BUSINESS WIRE) --
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that on November 4, 2010 the FDA Gastrointestinal (GI) Drugs Advisory Committee voted in favor (8-4) that endoscopically-diagnosed gastric/duodenal ulcers are an adequate primary efficacy endpoint for evaluating products intended to prevent NSAID-associated upper gastrointestinal (UGI) toxicity.
The Advisory Committee's vote supports the clinical design of the Phase III trial evaluating PA32540, a novel integrated therapy comprised of enteric-coated aspirin (325 mg) and immediate release omeprazole (40 mg), for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. POZEN is developing PA32540 under the Special Protocol Assessment (SPA) agreed to with the FDA. The Advisory Committee's favorable vote, although not binding, will be considered by the FDA in its final review of this matter.
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and a focus on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years - something almost no other small pharmaceutical company has done. Funded by these two milestone/royalty streams, POZEN is now creating a portfolio of cost-effective integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI toxicity. The lead candidate, PA32540, is being investigated for the secondary prevention of cardiovascular disease and has entered Phase III. POZEN is retaining commercial control of the pipeline assets and will launch creatively using a new sales force model and digital communications. 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: http://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 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 Annual 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.
SOURCE: POZEN Inc.