AstraZeneca and POZEN Inc. today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN 400) tablets, a product 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 ulcers. VIMOVO is a fixed-dose combination of enteric coated naproxen and immediate release esomeprazole under co-development by AstraZeneca and POZEN.
“Nearly 151 million people worldwide suffer from osteoarthritis. However, up to one third of osteoarthritis patients change therapy in a year, primarily due to lack of pain-relieving efficacy, and 60% of patients do not continue to adhere to an NSAID and PPI combination treatment after the third NSAID prescription,” said Lori Kreamer, Global Product Vice President, AstraZeneca. “If approved, VIMOVO may provide OA patients at risk of NSAID-associated ulcers a new treatment option that offers both enteric coated naproxen and immediate release esomeprazole in a single pill.”
In June 2009, POZEN submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO. The NDA was accepted on 31 August, 2009, and is currently under review.
NOTES TO EDITORS:
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.
Osteoarthritis (OA) is one of the oldest and most common forms of arthritis. Known as the “wear-and-tear” kind of arthritis, OA is a chronic condition characterized by the breakdown of the joint’s cartilage. Cartilage is the part of the joint that cushions the ends of the bones and allows easy movement of joints. The breakdown of cartilage causes the bones to rub against each other, causing stiffness, pain and loss of movement in the joint.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic disease, mainly characterized by inflammation of the lining, or synoviam, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. RA affects approximately 1.3 million Americans.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis (sacroiliac joints). Ankylosing spondylitis may also cause inflammation and pain in other parts of the body as well.
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 a development and commercialization with AstraZeneca for VIMOVO™, the proposed trade name for the proprietary fixed dose combination of enteric coated naproxen with the proton pump inhibitor immediate release 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.
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: www.astrazeneca.com
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