December 30, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
North Carolina-based pharmaceutical company Pozen confirmed this week that a deal with Johnson & Johnson to commercialize migraine drug MT 400 in South America has been terminated.
The deal was to commercialize the treatment for migraines in four separate countries, according to the News Observer. In a regulatory filing last week, it was announced that the two companies would be ending their agreement, which dates back to 2011.
As a result of the termination, Pozen will receive $257,300 in licensing revenue in its fiscal fourth quarter, and there is “no dispute” between the two businesses as of right now. Under the deal, Johnson & Johnson had the right to market MT 400 in Brazil, Colombia, Peru and Ecuador.
Pozen and Sanofi Part Ways
Earlier this month, Pozen announced that it had terminated its agreement with Sanofi to commercialize investigational products, PA8140 and PA32540. The effective date for the termination was declared Nov. 29, 2014. As a result, all licenses granted to Sanofi were revoked. This news came after the U.S. Food and Drug Administration provisionally approved of the name YOSPRALA for the two drugs.
“Our goal at Pozen continues to be to maximize shareholder return,” said John Plachetka, chairman, president and chief executive officer of Pozen. “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. 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.”
Two phase 3 clinical studies that looked at more than 1,000 patients found that YOSPRALA could be an effective form of treatment. Specifically, the aspirin showed positive results in patients with gastric ulcers and upper gastrointestinal adverse events.
“Given that the target population for YOSPRALA could exceed 20 million patients in the U.S., we will be fully engaged in the near term evaluating strategic options available to the company,” Plachetka continued.
Pozen primarily specializes in developing therapeutics for unmet medical needs. It also focuses on licensing its products to other pharmaceutical companies for commercialization.
