POZEN today announced that it and Sanofi US have mutually agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective November 29, 2014. As of the effective date of the termination, all licenses granted to Sanofi US will be terminated and all rights to the products will revert to POZEN.
Additionally, the proposed tradename for these products, YOSPRALA, was provisionally approved by the U.S. Food and Drug Administration (FDA) pending final approval of the New Drug Application (NDA). In the future, PA8140 will be referred to as YOSPRALA 81/40 (enteric-coated aspirin 81 mg/immediate release omeprazole 40 mg) and PA32540 (enteric-coated aspirin 325 mg/immediate release omeprazole 40 mg) will be referred to as YOSPRALA 325/40.
“Our goal at POZEN continues to be to maximize shareholder return. Management and the Board of Directors are taking this opportunity to evaluate all strategic options for YOSPRALA and POZEN,” said Dr. John Plachetka, Chairman, President and Chief Executive Officer. “As we continue to work with the FDA during these final weeks leading up to our December 30 th PDUFA date, we are very happy with the current FDA-proposed package insert. With respect to how well YOSPRALA may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product. Given that the target population for YOSPRALA could exceed 20 million patients in the US, we will be fully engaged in the near term evaluating strategic options available to the company.”