Sanofi, Pozen, Inc. Terminate U.S. License Agreement For Gastric Ulcer Drugs

Published: Dec 01, 2014

Sanofi, Pozen Terminate U.S. License Agreement For Gastric Ulcer Drugs

December 1, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

French drugmaker Sanofi and North Carolina-based drug company Pozen have announced the termination of their agreement for commercialization of Pozen’s investigational products for gastric ulcers, PA8140 and PA32540, effective Nov. 29, though neither company said why the deal would end. As a result, shares of Pozen were down 17 percent in early morning trading Monday, while Sanofi’s were up nearly 1 percent.

The deal, which was struck in September 2013, had the potential to be worth $35 million. At the launch of the partnership, Sanofi agreed to pay Pozen $15 million upfront, with a further $20 million at set milestones. Under the terms of the deal, Sanofi received exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States.

When the partnership was formed, Anne Whitaker, president of the North America pharmaceuticals division at Sanofi US, noted Sanofi’s “strong heritage and expertise in the cardiovascular space” and said that the PA products were “an important addition” to Sanofi’s strong CV 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. Sanofi has not commented on the termination of the deal.

The timing of the termination is significant because Pozen has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for PA8140 and PA32540. The review has a scheduled decision date of Dec. 30, 2014. Pending the decision on the application, the FDA has approved the name Yosprala 81/40 for PA8140 and Yosprala 325/40 for PA32540.

Both drugs are designed for the secondary prevention of cardiovascular disease in patients who have developed or who could develop aspirin-induced gastric ulcers. Pozen describes each product as, “a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.”

“As we continue to work with the FDA during these final weeks leading up to our December 30 PDUFA date, we are very happy with the current FDA-proposed package insert,” Chairman, President and Chief Executive Officer of Pozen John Plachetka said in a statement. “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.”

Plachetka estimated that the market for the drugs could exceed 20 million patients in the U.S.

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