06 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Sanofi and Pozen signed an exclusive license agreement for the commercialization of Pozen's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated aspirin in a single tablet (PA), PA8140 and PA32540.
Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the US. Pozen will receive an upfront payment of $15 million and will be eligible for pre-commercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales.
Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN will retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZEN will transfer the NDA to Sanofi US. The NDA was submitted in March 2013 and accepted for filing in May 2013 by the U.S. Food and Drug Administration (FDA).
Ms Anne Whitaker, president, North America Pharmaceuticals, Sanofi, US, said that, "Sanofi has a strong heritage and expertise in the cardiovascular space, with Lovenox, Plavix, and most recently Multaq, and the PA products are an important addition to our already strong CV portfolio. The PA products have the potential to be an effective solution for the millions of patients at risk for gastric ulcers from chronic aspirin use in the prevention of secondary cardiovascular disease. We look forward to bringing this therapy to patients and healthcare providers."
Dr John R Plachetka, chairman, president and chief executive officer, Pozen, said that, "We are pleased to have Sanofi US commercialize PA8140 and PA32540 in the US. We have been excited about the results of our phase III clinical trials and look forward to the prospect of making this product available to cardiovascular patients at risk for gastric ulcers. Sanofi's dominant CV heritage and strong commitment to PA, make them the right partner for these products."