AstraZeneca Announces FDA Acceptance of New Drug Application for VIMOVO

Monday, 31 August 2009

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted on June 30, 2009 by its development partner, POZEN, Inc., for VIMOVO (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN400) tablets. 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, 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 ulcers. Unfortunately, only a quarter of OA patients on NSAIDs are prescribed the gastroprotective agent (GPA) therapy they need, and up to 60% of patients will not adhere to the recommended PPI co-therapy after the third NSAID prescription, making VIMOVO a potentially important treatment option.

In accordance with the terms of the agreement between AstraZeneca and POZEN, the FDA’s notification of acceptance of the NDA filing for VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN.


About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:


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