- POZEN announced that the U.S. Food and Drug Administration (FDA) accepted for review, the New Drug Application (NDA) for PA8140/PA32540. Both products are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA has assigned a user fee goal date of January 24, 2014. POZEN is seeking approval for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
- Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that PA10040, POZEN’s proprietary combination of aspirin (100 mg) and omeprazole (40 mg), had comparable bioavailability, and is bioequivalent to a European Union (E.U.) reference listed enteric-coated (EC) aspirin (100 mg). The 100 mg dose of aspirin is most commonly used in Europe and in other ex-U.S. regions.
- Data from a post-hoc analysis of diabetic subpopulation results from two POZEN Phase 3 PA32540 (325 mg EC aspirin / 40 mg immediate-release omeprazole) studies were presented at the American Diabetes Association’s 73 rd Scientific Session. Nearly 40% of patients in the Phase 3 studies had diabetes and were on aspirin (325 mg) for secondary prevention of cardiovascular (CV) events. In this subpopulation (n=400), PA32540 was associated with a significantly lower rate of endoscopic gastroduodenal ulcers as compared to taking aspirin alone (2.3% vs. 11.2%, p<0.001). A lower rate of treatment discontinuation was also observed in this subpopulation (1.4% vs. 5.9%, p=0.018).
- On July 26, 2013, the United States Court of Appeals for the Federal Circuit denied a petition by Par Pharmaceuticals Inc. (Par) and Doctor Reddy’s Laboratories (DRL) for a rehearing en banc in connection with its September 2012 decision holding that U.S. Patent 7,332,183 covering the Treximet formulation was valid, enforceable and infringed by their respective Abbreviated New Drug Application (ANDA) products.
- Partnership discussions for PA continue to progress. While there can be no assurances, the Company continues to expect to close a partnership deal in 2013.
- Q2 2013 global net sales of VIMOVO by AstraZeneca, as defined under our agreement, were $23.3 million, up 19% from Q1 2013 and 41% vs. Q2 2012. POZEN earned a royalty of $1.7 million in Q2 2013, a 30% increase over Q2 2012. As discussed in our Q1 Earnings Call, AstraZeneca is discontinuing certain promotional activities in countries where they have not seen a positive effect, including the U.S. and most of the E.U.
POZEN Reports Second Quarter 2013 Results
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