Sanofi and the biopharmaceutical company POZEN, have signed a license agreement for the commercialization of POZEN's tablets combining immediate-release omeprazole, a proton pump inhibitor, and enteric-coated aspirin in a single tablet (i.e, PA), PA8140 and PA32540. Under the agreement, Sanofi will have rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15 million and be eligible for precommercial 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 US. 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 FDA.