Sanofi U.S. has signed an exclusive licensing agreement with Pozen Inc. to commercialize the pharmaceutical company's investigational cardiovascular drugs, PA8140 and PA32540.
Under the agreement, Bridgewater-based Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 milligrams or less of enteric-coated aspirin in the United States.
Sanofi will pay Pozen $15 million up front, plus North Carolina-based Pozen will be eligible for precommercial milestone payments of up to $20 million, along with future milestone payments and royalties on product sales.
Sanofi will be responsible for all domestic sales, marketing, manufacturing and future development for the licensed PA products. The drugs are intended to treat cardiovascular patients at risk for aspirin-induced gastric ulcers.
Anne Whitaker, president of North American pharmaceuticals at Sanofi US, said Pozen's PA products will enhance Sanofi's cardiovascular portfolio.
"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," Whitaker said in a statement today. "We look forward to bringing this therapy to patients and health care providers."
Pozen will retain responsibility for obtaining approval of the new drug application, after which Pozen will transfer the NDA to Sanofi. The application was submitted to the U.S. Food and Drug Administration in March.
Pozen CEO John Plachetka said the company is excited about results from late-stage clinical trials, and believes Sanofi's strong heritage in cardiovascular products make it the right partner to market these products.
Based in Chapel Hill, N.C., Pozen develops therapeutics for unmet medical needs and licenses those products to larger pharmaceutical companies for commercialization. Products in its PA portfolio are being developed to reduce gastric ulcers and other complications compared with taking enteric-coated or plain aspirin alone.
Its first candidates, PA32540 and PA8140, are coordinated-delivery tablets combining immediate-release omeprazole, the active ingredient in heartburn drugs like Prilosec, layered around a pH-sensitive coating of an aspirin core.
Many people take aspirin to prevent heart problems, but long-term use can cause ulcers. In Pozen's drugs, the omeprazole is released as soon as the tablet is taken, and the aspirin is released over time. The products are intended to be taken orally once daily.
Contributing: The Associated Press