Results of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk of Upper GI Damage in Healthy Adults

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Tue Oct 27, 2009 8:30am EDT

Study Receives a Presidential Award from ACG
CHAPEL HILL, N.C.--(Business Wire)--
POZEN Inc. (NASDAQ: POZN) announced today the results of a Phase I study that
showed a novel, investigational combination of enteric-coated aspirin (EC-ASA)
and immediate-release omeprazole known as PA65020, is associated with a
significantly decreased risk of GI mucosal damage compared to analgesic doses
(650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in
healthy adults treated for one month. The randomized, double-blind study
highlighted that the majority of patients taking over-the-counter EC-ASA
experienced significant gastroduodenal damage. The data were presented at the
American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting today
in San Diego, CA. ACG presented the study with a Presidential Award for winning
science. 

"These findings are encouraging for the millions of people who require analgesic
doses of aspirin but are at risk for upper GI damage as a result of this
treatment," said Dr. John Fort, Chief Medical Officer. "More than five billion
units of aspirin in all of its forms are sold in the U.S. each year. Upper GI
toxicity is a common complication of aspirin therapy. Even modified-release
aspirin formulations do not significantly lower the risk of GI events." 

About the Study

The study examined 20 healthy adults with normal endoscopy, defined as a Grade 0
Lanza score at baseline. Dosing schedules were as follows: PA65020 was
administered in two tablets (fixed dose combination of EC-ASA 325 mg and IR
omeprazole 20 mg, and EC-ASA 325 mg) twice daily; EC-ASA 650 mg was administered
as two 325 mg tablets twice daily. Following 28 days of therapy, 15% of the
PA65020 treatment group versus 85% of the EC-ASA treatment group had Grade 3 or
4 Lanza scores (P<0.001), the study`s primary endpoint. In addition, 65% of
subjects in the PA65020 group had Grade 0 Lanza scores, meaning no visible
gastroduodenal lesions, versus 0% of subjects in the EC-ASA group. An assessment
of gastric and/or duodenal ulcers showed that no patients in the PA65020
treatment group versus 40% of those in the EC-ASA treatment group (P=0.003) had
evidence of these complications at day 28. No serious adverse events were
reported and there were no withdrawals due to adverse events. 

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 has decided to retain control of its aspirin product portfolio and is
evaluating how best to commercialize these product candidates. 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.

POZEN Inc.
Bill Hodges, Chief Financial Officer
919-913-1030

Copyright Business Wire 2009

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