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GEN News Highlights : May 3, 2010

FDA Clears Pozen and AstraZeneca’s Combination Naproxen-Esomeprazole

Phase III trials showed that therapy reduces risk of gastric ulcers in inflammatory disease patients.

Pozen received a $20 million milestone payment from AstraZeneca upon FDA approval of the companies’ Vimovo™, a delayed-release combination of enteric-coated naproxen and immediate-release esomeprazole.

FDA clearance covers use of the drug for treating the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as for reducing gastric ulcer risk in patients at risk of developing NSAID-associated gastric ulcers. Regulatory submission of the drug to the European authorities was filed in October 2009.

FDA approval was based on data from two pivotal PN400-301 and PN400-302 studies. The trials compared the incidence of gastric ulcer among patients treated either with Vimovo or enteric-coated naproxen. In the PN400-301 trial the incidence of gastric ulcer was 4.1% for the Vimovo group and 23.1% among patients given enteric-coated naproxen. The incidences of gastric ulcer in the PN400-302 trial were 7.1% and 24.3%, respectively.

Pozen granted AstraZeneca non-U.S. rights to Vimovo in 2006. Under the terms of the agreement Pozen received an up-front fee of $40 million. The deal included potential aggregate development and regulatory milestone payments of $160 million and $175 million in potential sales performance milestones along with sales royalties.

Pozen was responsible for the development and filing of the New Drug Application (NDA) in the U.S., and AstraZeneca retains full responsibility for development and regulatory filing of the drug outside of the U.S. as well as all aspects of manufacturing, marketing, sales, and distribution on a worldwide basis.