Pharma

N.C. pharma Pozen inks licensing deal for migraine drug in Latin America

The migraine drug developed by pharmaceutical company Pozen now has the opportunity for commercialization in […]

The migraine drug developed by pharmaceutical company Pozen now has the opportunity for commercialization in parts of Latin America under a new licensing deal inked with a Johnson & Johnson subsidiary.

Chapel Hill, North Carolina-based Pozen (NASDAQ:POZN) has already commercialized its compound MT 400 under the name Treximet, which is marketed through partner GlaxoSmithKline (NYSE:GSK). Liz Cermak, chief commercial officer for Pozen, said that Pozen’s licensing deal with GSK allows Pozen to retain rest-of-the-world rights to the compound in other doses.

Under the license agreement with JNJ (NYSE:JNJ) subsidiary Cilag, Cilag will be responsible for development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru under a different dosage than Treximet. While the partnership agreement with GSK yielded $25 million in initial payments to Pozen, the company isn’t saying how much it’s getting from JNJ. CFO Bill Hodges describes the up-front payment as “nominal.” An additional milestone payment will come upon regulatory approval in Brazil. The real money, he said, will come from royalty payments over the 15 years of sales of the drug in Latin America. During the first 10 years of sales, Cilag will pay Pozen a royalty in the high single digits; in the final five years of the agreement, the royalty will be in the low single digits. But it will take some time before those sales are realized. Hodges said that it could take about two years to get manufacturing operations in place.

Treximet, which generated $15.4 million in 2010 royalty revenue for Pozen, faces expiration of its U.S. marketing exclusivity on April 15. After that date, competitors can enter the market with generic versions of the drug. Pozen is currently involved in litigation trying to keep generics from entering the market. Cermak said that the expiration of U.S. marketing exclusivity has no bearing on the drug in Latin America.

Cermak said that JNJ is an ideal partner because the company already has an established sales team in the region and the migraine drug fits with the central nervous system drugs that JNJ already sells there. MT 400 will compete with other sumatriptan migraine drugs already available in Latin America, but Cermak said that the number of competitors for the drug are fewer there than in the United States.

Pozen will use the money it receives from the JNJ partnership to continue work on its drug pipeline, chiefly its PA platform that focuses on aspirin. Pozen is in phase 3 clinical trials for PA 32540, a compound that aims to offer patients the cardiovascular benefits of aspirin in a form that is safer on the stomach. Cermak said Pozen has sufficient funds to continue developing its PA platform. In the meantime, the company is continuing to look for partners that can commercialize MT 400 in other markets in the world.

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