Results from PN400-301/302 studies presented at American College of Rheumatology
Annual Scientific Meeting
Philadelphia, PA (October 19, 2009) – 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™ (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
VIMOVO is a fixed-dose combination of enteric-coated naproxen, a non-steroidal antiinflammatory
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
- 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)
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
PN400-301 and PN400-302 were 6-month, Phase III, randomized, double-blind,
controlled, multi-center clinical trials that together enrolled approximately 800 H. pylorinews
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
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™, 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:
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