Aug. 31, 2009 (Business Wire) -- POZEN Inc. (NASDAQ:POZN), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for VIMOVO™ (enteric-coated naproxen / immediate release esomeprazole magnesium, formerly know as PN 400). VIMOVO is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate release esomeprazole, a proton pump inhibitor (PPI), under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated gastric ulcers.
Nearly 27 million US residents and 140 million people worldwide suffer from OA,1 a disease commonly treated with NSAIDs. Although NSAIDs can relieve pain and reduce inflammation, half of OA patients on chronic NSAID therapy are at risk of developing NSAID associated gastric ulcers2. Only a quarter of OA patients on NSAIDs are prescribed the gastroprotective agent (GPA) therapy they need,2 and up to 60% of patients will not adhere to the recommended PPI co-therapy after the third NSAID prescription,2 making VIMOVO a potentially important treatment option.
In accordance with the terms of the agreement between POZEN and AstraZeneca, the FDA’s notification of acceptance of the NDA filing for VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved in 2008 by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, and with AstraZeneca for VIMOVO™, the proposed trade name for the proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The Company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For detailed company information, including copies of this and other press releases, see POZEN’s website: www.pozen.com.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.
