- POZEN announced positive top-line results from two randomized, double-blind, multi-center, pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg). Detailed results will be submitted for journal publication and presentation at a future scientific meeting.
- These pivotal studies met their primary endpoint of significant reductions in the cumulative incidence of gastric ulcers following administration of PA32540 vs. 325 mg enteric-coated (EC) aspirin over six months.
- These pivotal studies also met their key secondary endpoints, and reported adverse events were consistent with the trial population and the known adverse event profile of aspirin and omeprazole.
- The Company has recently completed a Phase 1 study to assess the bioequivalence of PA32540 to enteric-coated aspirin 325 mg using acetylsalicylic acid (ASA) as the analyte as requested by the U.S. Food and Drug Administration (FDA) and believes that the results demonstrate bioequivalence between the two dosage forms. The Company will attempt to obtain the FDA's concurrence before the New Drug Application (NDA) submission.
- As previously disclosed in a Current Report on Form 8-K dated April 26, 2012, during a pre-submission meeting for the Company’s NDA for PA32540, the FDA suggested that the Company also seek approval for a lower dose formulation of the product containing 81 mg of enteric-coated aspirin. As a result, the company is assessing the impact on the strategy and timing of the NDA submission for PA32540. Please refer to the Form 8-K for additional information.
- Partnership discussions for PA continue to progress. We believe that we remain on track regarding our goal to secure a partnership by year-end 2012 and have had preliminary discussions with some potential partners about the recent request to make available a lower strength of PA32540.
- Q1 2012 net sales of VIMOVO™ (naproxen / esomeprazole magnesium) delayed-release tablets were $15.9 million, generating a royalty of $1.3 million. VIMOVO has now been approved in 50 countries and launched in 28 countries.
POZEN Reports PA32540 / PA8140 Updates And First Quarter 2012 Financial Results
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