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Sanofi US and POZEN Sign Exclusive License Agreement for the Commercialization of PA8140/PA32540 Tablets in the U.S.
Date:9/4/2013

f 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 the U.S. Food and Drug Administration (FDA). 

John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN Inc. said, "We are pleased to have Sanofi US commercialize PA8140 and PA32540 in the US.  We have been excited about the results of our Phase 3 clinical 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."

About PA  POZEN has created a portfolio of investigational integrated aspirin therapies - the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.

The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

About Cardiovascular DiseasePatients with established coronary heart disease or cerebrovascular disease have a high risk of a subsequent cardiovascular event including myocardial infarction (MI), stroke and death from cardiovascular disease. For such patients, lifestyle changes and drug therapy are of proven benefit and may improve outcomes. Heart disease is the leading cause of death for both men and women in A
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