POZEN Receives Decision From AstraZeneca To File PN 400 NDA

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 May 2009 - 1:00 PDT

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POZEN Inc. (NASDAQ: POZN) reported that AstraZeneca has made the decision to have POZEN file the New Drug Application (NDA) for PN 400 with the United States Food and Drug Administration (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.

Source
POZEN Inc.