Patients Taking Vimovo Showed a Decrease in Incidence of NSAID-Associated Ulcers
Results from PN400-301/302 studies presented at American College of Rheumatology Annual Scientific Meeting
PHILADELPHIA, Oct. 19 /PRNewswire-FirstCall/ -- 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:
-- 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 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 ABOUT VIMOVO:
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.
ABOUT OSTEOARTHRITIS:
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.
ABOUT POZEN:
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.
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: www.astrazeneca.com.
Source: AstraZeneca
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