CHAPEL HILL, N.C.--(BUSINESS WIRE)--
POZEN Inc. (NASDAQ: POZN) announced today that the U.S. Food and
Drug Administration (FDA) has completed its internal discussions and
informed the Company that there is no change to previous agreements that
gastric ulcer incidence is an acceptable primary endpoint for POZEN’s
clinical programs. In October 2008, the FDA had informed POZEN during
its review of both the Special Protocol Assessment (SPA) for PA32540 and
the Statistical Analysis Plan (SAP) for PN 400 that the FDA was
conducting an internal review on the acceptability of gastric ulcers as
a primary endpoint in clinical studies.
PN 400, an investigational product under development by POZEN and
AstraZeneca, is a fixed dose combination of enteric-coated naproxen with
immediate release esomeprazole for the treatment of the signs and
symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing
spondylitis in patients who are at risk of developing NSAID associated
gastric ulcers. The two pivotal ulcer risk reduction studies have been
completed and met their primary endpoints. In both studies, patients
taking PN 400 experienced significantly fewer endoscopically confirmed
gastric ulcers compared to subjects receiving enteric-coated naproxen
during the six-month treatment period. The NDA submission is planned for
mid-2009.
PA32540, a patented investigational product containing aspirin (325 mg)
and omeprazole (40 mg) in a unique dosage form under development by
POZEN, is designed to deliver the cardiovascular benefits of aspirin
with a lower incidence of gastric ulcers than enteric-coated aspirin.
POZEN requested an SPA from the FDA for the design of the PA32540 Phase
3 clinical studies. The proposed primary endpoint was the reduction in
the incidence of endoscopic gastric ulcers. With the FDA’s determination
that endoscopic gastric ulcer incidence continues to be an acceptable
endpoint, POZEN will seek to finalize the SPA for PA32540.
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 recently approved 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 proprietary fixed dose combinations 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 September 30,
2008. We do not intend to update any of these factors or to
publicly announce the results of any revisions to these forward-looking
statements.
Source: POZEN Inc.
<b>POZEN Inc.</b>
<b>Bill Hodges, Chief Financial Officer</b>
<b>919-913-1030</b>
