POZEN Inc. (POZN) Receives Decision from AstraZeneca (AZN) to File PN 400 NDA
POZEN Inc. (NASDAQ: POZN) reported that AstraZeneca (NYSE: AZN) has made the decision to have POZEN file the New Drug Application (NDA) for PN 400 with the FDA. POZEN continues to target a mid-2009 NDA filing and expects to receive a milestone payment of $10 million when the NDA 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 (an NSAID) with esomeprazole magnesium, a proton pump inhibitor (PPI), 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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