Sanofi signed an exclusive license agreement with Pozen to commercialize Pozen's investigational coordinated-delivery tablets PA8140 and PA32540, which combine immediate-release omeprazole (a proton pump inhibitor) and enteric-coated aspirin in a single tablet (PA).
Pozen will receive an up-front payment of $15 million and will be eligible for precommercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales. Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States (PA32540 contains 325 mg of aspirin, and PA8140 contains 81 mg of aspirin), including 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 Pozen will transfer the NDA to Sanofi.
Pozen created the PA portfolio with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone. An indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
"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," John R. Plachetka, Pharm.D., chairman, president, and CEO of Pozen, said in a statement. "Sanofi's dominant CV heritage and strong commitment to PA make them the right partner for these products."