Sanofi US and Pozen, Inc. have signed an exclusive license agreement to commercialize Pozen's investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated aspirin in a single tablet, PA8140 and PA32540.
Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the U.S. and Pozen will receive an upfront payment of $15 million and will be eligible for milestone payments of as much as $20 million, as well as royalties on sales. Sanofi U.S. will be responsible for sales, marketing, manufacturing and future development for the licensed PA products in the U.S. Pozen will retain responsibility for obtaining approval of the NDA, and will then transfer the NDA to Sanofi US. The NDA was submitted to the FDA in March 2013.
"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," said Anne Whitaker, president, North America Pharmaceuticals at Sanofi US. "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."
John R. Plachetka, Pharm.D., chairman, president and chief executive officer of Pozen, said, "We are pleased to have Sanofi US commercialize PA8140 and PA32540 in the U.S. We have been excited about the results of our Phase III 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."