Sanofi and Pozen, a pharmaceutical company specializing in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization, have announced an exclusive license agreement for commercialization of Pozen's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet (PA), PA8140 and PA32540. Sanofi will have exclusive rights to commercialize all PA combinations that contain 325mg or less of enteric-coated aspirin in the U.S. 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.
Anne Whitaker, president, North America Pharmaceuticals at Sanofi, said. "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.”
Sanofi will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products. Pozen will retain responsibility for obtaining approval of the NDA, after which time Pozen will transfer the NDA to Sanofi. The NDA was submitted in March and accepted for filing in May by the FDA.