Study Receives a Presidential Award from ACG
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 27, 2009--
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.
Source: POZEN Inc.
POZEN Inc.
Bill Hodges, Chief Financial Officer
919-913-1030
