$10 Million Milestone Earned
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 31, 2009--
POZEN Inc. (NASDAQ:POZN), today announced that the U.S.
Food and Drug Administration (FDA) has accepted the New Drug Application
(NDA) for VIMOVO™ (enteric-coated naproxen / immediate
release esomeprazole magnesium, formerly know as PN 400). 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,1 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
ulcers2. Only a quarter of OA patients on NSAIDs are
prescribed the gastroprotective agent (GPA) therapy they need,2 and
up to 60% of patients will not adhere to the recommended PPI co-therapy
after the third NSAID prescription,2 making VIMOVO a
potentially important treatment option.
In accordance with the terms of the agreement between POZEN and
AstraZeneca, the FDA’s notification of acceptance of the NDA filing for
VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN.
About POZEN
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 development and commercialization alliances with
GlaxoSmithKline for Treximet®, which was
approved in 2008 by the United States Food and Drug Administration for
the acute treatment of migraine attacks, with or without aura, in
adults, and 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 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.
Statements included in this press release that are not historical in
nature are “forward-looking statements” within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of
1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements, which
are based on management’s current expectations and are subject to a
number of risks and uncertainties, including, but not limited to, our
failure to successfully commercialize our product candidates; costs and
delays in the development and/or FDA approval of our product candidates,
including as a result of the need to conduct additional studies, or the
failure to obtain such approval of our product candidates, including as
a result of changes in regulatory standards or the regulatory
environment during the development period of any of our product
candidates; uncertainties in clinical trial results or the timing of
such trials, resulting in, among other things, an extension in the
period over which we recognize deferred revenue or our failure to
achieve milestones that would have provided us with revenue; our
inability to maintain or enter into, and the risks resulting from our
dependence upon, collaboration or contractual arrangements necessary for
the development, manufacture, commercialization, marketing, sales and
distribution of any products, including our dependence on
GlaxoSmithKline for the sales and marketing of Treximet; competitive
factors; our inability to protect our patents or proprietary rights and
obtain necessary rights to third party patents and intellectual property
to operate our business; our inability to operate our business without
infringing the patents and proprietary rights of others; general
economic conditions; the failure of any products to gain market
acceptance; our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events, including those discussed herein and in
our Quarterly Report on Form 10-Q for the period ended June 30, 2009. We
do not intend to update any of these factors or to publicly announce the
results of any revisions to these forward-looking statements.
1 World Health Organization. “Point prevalence (‘000s) for
selected causes: by sex, age and WHO subregion b,: 2001.” www.who.int/healthinfo/statistics/gbdwhoregionprevalence2001.xls.
2 12006 Adelphi Arthritis VI DSP
Source: POZEN Inc.
POZEN
Bill Hodges, Chief Financial Officer, 919-913-1030
