PHILADELPHIA, Oct. 19 AstraZeneca (NYSE: AZN) and POZEN Inc. (Nasdaq: POZN) today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.
The data demonstrated that patients at risk for developing NSAID-associated gastric ulcers taking VIMOVO(TM) (naproxen/esomeprazole magnesium, formerly known as PN 400) experienced significantly fewer endoscopically confirmed gastric ulcers (GU) compared with patients taking enteric-coated (EC) naproxen (500 mg) alone. Data from study PN400-301 showed a 4.1% incidence of GU in patients taking VIMOVO, compared to 23.1% among patients taking EC naproxen (p<0.001). Study PN400-302 showed a 7.1% incidence of GU among patients taking VIMOVO, compared to 24.3% with EC naproxen (p<0.001).
VIMOVO is a fixed-dose combination of enteric-coated naproxen, a 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.
"These results provide new information about VIMOVO and the incidence of NSAID-induced endoscopically confirmed gastric ulcers in patients with osteoarthritis," said Marc C. Hochberg, M.D., M.P.H., professor of medicine and head of the Division of Rheumatology and Clinical Immunology, University of Maryland School of Medicine in Baltimore, and co-principal investigator for the study. "If approved, VIMOVO will provide arthritis patients at risk for NSAID associated gastric ulcers a new treatment option that combines enteric-coated naproxen and immediate release esomeprazole in a single pill."
Studies 301 and 302 also analyzed the reduction in incidence of endoscopically confirmed GU among patients taking VIMOVO and EC naproxen who were on concomitant low-dose aspirin (LDA) therapy. Data combined from both studies showed that:
Additional analyses examined the incidence of endoscopically confirmed duodenal ulcers (DU) among patients taking VIMOVO. In study 301, patients taking VIMOVO experienced a 0.5% incidence of DU compared to 5.1% taking EC naproxen (p=0.003), and in study 302, patients taking VIMOVO experienced a 1.0% incidence of DU, compared to 5.7% incidence among patients taking EC naproxen (p=0.007).
The most frequently reported adverse events among patients taking both VIMOVO and EC naproxen were GI disorders, including dyspepsia, erosive esophagitis and erosive duodentis. Commonly reported treatment emergent adverse events (experienced by > than 10% patients in either treatment group) included erosive gastritis, gastritis, dyspepsia and erosive duodentis. In PN400-301 (n=434), 21% patients taking VIMOVO experienced erosive gastritis, as compared to 37% taking EC naproxen. Among patients taking VIMOVO, 18% experienced gastritis, as compared to 13% taking EC naproxen, and 16% of the patients reported dyspepsia, as compared to 30% taking EC naproxen. 2% of patients taking VIMOVO experienced erosive duodentis as compared to 14% taking EC Naproxen. In PN400-302 (n=420), incidences of erosive gastritis were reported by 18% patients taking VIMOVO, as compared to 39% taking EC naproxen. 16% of patients taking VIMOVO experienced gastritis, as compared to 15% taking EC naproxen, and 19% patients taking VIMOVO reported dyspepsia, as compared to 23% taking EC naproxen.
PN400-301 and PN400-302 were 6-month, Phase III, randomized, double-blind, controlled, multi-center clinical trials that together enrolled approximately 800 H. pylori-negative adults with OA, RA, AS, or any other condition that required daily NSAID therapy and were at risk of ulcers. Subjects in each study were randomized to receive either VIMOVO/E20 (EC naproxen 500 mg/IR esomeprazole 20 mg) tablets twice-daily or EC naproxen 500 mg twice-daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months.
On August 31, 2009, the US Food and Drug Administration (FDA) informed AstraZeneca and POZEN Inc. that it had accepted the New Drug Application (NDA) for VIMOVO, submitted on June 30, 2009. AstraZeneca submitted a Marketing Authorization Application (MAA) to the European Union via the Decentralized Procedure for VIMOVO on October 16, 2009.
NOTES TO EDITORS
VIMOVO is an investigational product under co-development by AstraZeneca and POZEN, Inc. that combines enteric coated naproxen (an NSAID) with immediate release esomeprazole, a proton pump inhibitor (PPI). VIMOVO is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers.
Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 151 million individuals worldwide, and impacting approximately 18% of women and 9.6% of men aged 60 and above. A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness. Osteoarthritis commonly affects the hands, feet, spine or large weight-bearing joints, such as the hips and knees.
ABOUT RHEUMATOID ARTHRITIS:
Rheumatoid arthritis (RA) is a chronic disease, mainly characterized by inflammation of the lining, or synovium, 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 and unmet medical needs where it can improve efficacy, safety and o/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 AstraZeneca for VIMOVO(TM), the proposed trade name for the proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet under development for conditions including 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 the POZEN 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.
-- In patients taking LDA (n=201), the incidence of GU in the VIMOVO arm was 3.0% compared to 28.4% for those taking EC naproxen (p<0.001) -- Patients taking VIMOVO who were not taking LDA (n=653) experienced a 6.4% incidence of GU compared to 22.2% among those taking EC naproxen (p<0.001)