Sanofi, POZEN Sign Deal For Commercialization Of PA8140/PA32540 Tablets In U.S.

(RTTNews) - Sanofi US and POZEN Inc. (POZN) on Wednesday announced the signing of an exclusive license agreement for the commercialization of POZEN's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor, and enteric-coated aspirin in a single tablet, PA8140 and PA32540.

Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15MM and will be eligible for pre-commercial milestone payments of up to $20MM and other future milestone payments and royalties on product sales.

Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S.

POZEN will retain responsibility for obtaining approval of the New Drug Application, after which time POZEN will transfer the NDA to Sanofi US.

The NDA was submitted in March and accepted for filing in May by the U.S. Food and Drug Administration.