POZEN Inc. (ticker: POZN, exchange: NASDAQ Global Market (.O))
News Release -
1-Nov-2007
Pozen Announces Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDACHAPEL HILL, N.C., Nov 01, 2007 (BUSINESS WIRE) -- POZEN Inc. (NASDAQ:POZN) announced today that its amended response
to the FDA approvable letter for Trexima received on August 1, 2007
has been accepted for review by the U.S. Food and Drug Administration
(FDA). The FDA has also notified POZEN that it considers the
submission to be a complete, Class II response (six months) which
could result in a new decision date of April 15, 2008.
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 the proposed product candidate
Trexima(TM) combining sumatriptan, formulated with RT technology, and
naproxen sodium in a single tablet for the acute treatment of
migraine, which is currently under review by the United States Food
and Drug Administration, and with AstraZeneca for the proprietary
fixed dose combination of the proton pump inhibitor esomeprazole
magnesium with naproxen 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; 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; outcomes of
outstanding litigation; and one-time events, including those discussed
herein and in our Quarterly Report on Form 10-Q for the period ended
June 30, 2007. 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 or
Fran Barsky, Director, Investor Relations, 919-913-1044
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