- POZEN is currently preparing a New Drug Application (NDA) for its investigational products containing enteric-coated (EC) aspirin and immediate release omeprazole, including two dosage forms, PA32540 containing 325 mg of aspirin and PA8140, a low dose formulation containing 81 mg aspirin. POZEN continues to anticipate filing the NDA for both products no later than Q2 2013.
- POZEN announced positive top-line results from two randomized, double-blind, multi-center, pivotal Phase 3 clinical trials of PA32540. Detailed results were presented in the fall at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting and the American Heart Association (AHA) Scientific Sessions 2012.
- In August 2012, POZEN gained clarity from the Medicines Evaluation Board (MEB) in the Netherlands regarding the development program required for the approval in the European Union of PA including a lower dosage form containing 100 mg of aspirin and 40 mg of omeprazole (PA10040). The MEB agreed that no Phase 3 clinical trials for PA10040 to demonstrate the reduction of gastric ulcers vs. EC aspirin 100 mg would be necessary. MEB required 2 additional Phase 1 studies: a pharmacodynamic study demonstrating appropriate gastric pH control with PA10040 as well as a study to demonstrate bioequivalence of PA10040 to a currently marketed EC aspirin 100 mg product using aspirin as the analyte. The MEB also agreed to be the Reference Member State in a decentralized filing procedure for PA32540/PA10040.
- Partnership discussions for PA continue to progress. While there can be no assurances, the Company expects to close a partnership deal in 2013.
- Q4 2012 global net sales of VIMOVO ® (naproxen / esomeprazole magnesium) delayed-release tablets by AstraZeneca, as defined under our agreement, were $18.4 million, up 33% from Q4 2011 and 38% vs. Q3 2012. VIMOVO sales for 2012 were $64.3 million, up 90% over the prior year, led by strong growth outside the U.S. POZEN earned a royalty of $4.8 million in 2012, a 70% increase over 2011. As of the end of Q4 2012, AstraZeneca had filed for regulatory approval of VIMOVO in 80 countries; the product has been approved in 63 countries; and commercially launched in 52 countries.
- The United States Court of Appeals for the Federal Circuit affirmed the August 5, 2011 decision of the United States District Court for the Eastern District of Texas that had issued a favorable verdict in the litigation between POZEN and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the U.S. Food and Drug Administration (FDA) to market generic copies of Treximet ® (sumatriptan / naproxen sodium). Treximet is marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline.
- The United States Patent and Trademark Office has issued U.S. Patent 8,206,741 entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” to POZEN. This patent includes claims to pharmaceutical compositions that contain aspirin and a proton pump inhibitor (PPI) and covers POZEN’s PA drug candidates. The ‘741 patent is the second U.S. patent issued to POZEN for the coordinated delivery of NSAIDs, but the first in which the claims are focused on aspirin-based products.
POZEN Reports Fourth Quarter & Year End 2012 Results
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