POZEN Informed Of FDA Internal Review Of Gastric Ulcers As A Primary Endpoint In Clinical Trials

Main Category: GastroIntestinal / Gastroenterology
Article Date: 20 Oct 2008 - 0:00 PDT

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POZEN Inc. (NASDAQ: POZN), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that, as part of the FDA's on-going discussions with the Company and their review of both the Special Protocol Assessment (SPA) for PA32540 and the Statistical Analysis Plan (SAP) for PN 400, the FDA is conducting an internal review on the acceptability of using endoscopic gastric ulcers as a primary endpoint in clinical studies. The Company has been advised by the FDA that an internal meeting could take place on this matter as soon as the FDA can gather all the interested parties together, but it did not expect that to happen until the first quarter of next year.

Dr. Marshall E. Reese, executive vice president, product development said, "It is unclear at this time what impact, if any, the FDA's internal review will have on any previous agreements the Company has with the FDA on POZEN's PN or PA development programs. We will continue to progress our development program for PN 400 since these clinical trials have been operating under an agreed development plan with the FDA. We anticipate top-line data to be available by year end."

In April 2006, POZEN announced it completed an SPA and reached agreement with the FDA on the design of its pivotal trials for PN 200 (omeprazole 20 mg and naproxen 500 mg), which trial protocols specified the primary endpoint as the reduction in gastric ulcers versus enteric coated naproxen. After signing the collaboration agreement with AstraZeneca, the Company confirmed with the FDA that the development program agreed upon for PN 200 also applies to PN 400 (esomeprazole 20 mg and naproxen 500 mg).

In June 2008, POZEN submitted an SPA for the PA32540 pivotal studies, which are designed to demonstrate a reduction in gastric ulcers in subjects taking PA32540 versus subjects taking 325 mg of enteric coated aspirin. Based upon POZEN's recent communications with the FDA, the Company believes that confirmation of using endoscopic gastric ulcers as the primary endpoint is the only remaining open issue in the design of the pivotal trials.

While it is not possible to predict the outcome of the FDA's internal review, in the event that the agency determines that endoscopic gastric ulcers are not acceptable as the primary endpoint for our PN and PA trials, it is possible that POZEN will be required to meet other endpoints which may result in additional trials and associated increased costs and delay NDA approval.

POZEN will hold a webcast on Friday, October 17, 2008 at 8:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.

About POZEN

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 recently approved by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, 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". 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; 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 June 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.

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