POZEN Inc. (NASDAQ:POZN), today announced that Dr. Jay Goldstein,
Professor of Medicine with the Department of Medicine, University of
Illinois at Chicago and lead presenter for a PN 200 concept trial
(immediate release omeprazole 20 mg, and enteric coated naproxen 500
mg), gave a podium presentation on the PN 200 study results at
Digestive Disease Week on May 18, 2008.
PN 200 was a 400 patient concept trial conducted by POZEN.
Approximately 200 subjects each received PN 200 or enteric coated
naproxen 500 mg, twice a day, over a six-month treatment period.
Subjects underwent upper endoscopies at baseline and at one, three,
and six months. The primary endpoint was the cumulative incidence of
gastric ulcers. The study results indicated significantly fewer
endoscopically confirmed gastric ulcers in subjects on PN 200 compared
to subjects receiving enteric coated naproxen (8.3% v. 29.4%, pless
than0.001) during the six-month period.
POZEN and AstraZeneca entered into a co-development agreement for
PN 400 (immediate release esomeprazole 20 mg, and enteric coated
naproxen 500 mg) in August 2006. PN 400 is an investigational product
under clinical development in patients who require chronic
non-steroidal anti-inflammation drugs (NSAIDs) treatment for arthritis
pain, such as osteoarthritis and who are at risk for NSAID-associated
gastric ulcers. The PN 400 pivotal trials, which are similar in design
to the PN 200 study reported above, are now fully enrolled and are
expected to be completed by the end of 2008 with an NDA filing
anticipated in the first half of 2009.
Dr. John R. Plachetka, chairman, president and chief executive
officer stated, “The PN 200 concept trial demonstrated a significant
reduction in gastric ulcers over enteric coated naproxen and validates
previous findings from our proof-of-concept studies using Lanza
scores. We look forward to completion of the PN 400 trials using
esomeprazole in the formulation.”
Osteoarthritis is one of the most frequent causes of physical
disability among adults, affecting an estimated 20 to 30 million
people in the United States. Estimates from the National Institutes of
Health show that by 2030, 20 percent of Americans–about 70 million
people–will have passed their 65th birthday and will be at risk to
develop osteoarthritis.
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(TM), which was recently
approved by the United States Food and Drug Administration for the
acute treatment of migraine attacks; 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 March 31, 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.