Pozen to get milestone as AZ files for PN 400
Anglo-Swedish drug major partner AstraZeneca has made the decision to have US firm Pozen file the New Drug Application for PN 400 with the Food and Drug Administration. Pozen continues to target a mid-2009 NDA filing and expects to receive a milestone payment of $10.0 million when this is formally accepted for submission by the FDA.
The license agreement executed with AstraZeneca in August 2006 established a Phase III clinical development program for PN 400, an investigational compound, that combines the pain reliever naproxen with esomeprazole magnesium, a proton pump inhibitor, to support a potential indication for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing gastric ulcers.
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