Friday, May 30, 2014
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.
POZEN, a pharmaceutical company, has reported positive results from a phase I study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated (EC) omeprazole (40 mg), enteric-coated aspirin (81 mg) and clopidogrel (300 mg loading/75 mg daily). In the Co-Rx study, PA32540, a novel combination of 325 mg of aspirin and 40 mg immediate-release (IR) omeprazole, when dosed 10 hours apart from clopidogrel, was associated with greater platelet inhibition than synchronous administration of aspirin, clopidogrel and delayed-release omeprazole (46.5% versus 39.3%, respectively, at day 7(95% CI [2.57, 11.91]). These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy (DAPT) and gastroprotection.