POZEN Announces FDA Acceptance Of NDA For VIMOVO™

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals;  Bones / Orthopedics
Article Date: 02 Sep 2009 - 1:00 PDT

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POZEN Inc. (NASDAQ:POZN), 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.

1. World Health Organization. "Point prevalence ('000s) for selected causes: by sex, age and WHO subregion b,: 2001." http://www.who.int/healthinfo/statistics/gbdwhoregionprevalence2001.xls.
2. 12006 Adelphi Arthritis VI DSP

Source
Pozen

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