POZEN Inc. (ticker: POZN, exchange: NASDAQ Global Market (.O))
News Release -
15-Jan-2008
POZEN Submits Human Lymphocyte Study for Treximet(TM) (Formerly Known as Trexima(TM)) FDA Tentatively Accepts Proposed New Trade Name
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jan. 15, 2008--POZEN Inc.
(NASDAQ: POZN) announced today that it has submitted the findings from
the short-term human volunteer study of the genotoxic potential of
Treximet(TM) (formerly known as Trexima(TM)) to the U.S. Food and Drug
Administration (FDA). The results of this study, the design of which
was agreed upon with the FDA prior to its conduct, indicate that no
chromosomal aberrations were induced in peripheral blood lymphocytes
when Treximet was administered to volunteers for seven days. The
submission of this study report is in addition to the response made to
the FDA in October 2007 which provided clarifying information on the
Chinese Hamster Ovary (CHO) assay.
The company has received notification from the FDA that it has
tentatively accepted the trade name Treximet (formerly known as
Trexima), subject to final NDA Approval, for the proposed product
candidate combining sumatriptan 85 mg, formulated with RT
Technology(TM), and naproxen sodium 500 mg in a single tablet.
Treximet, which is currently under review by the FDA for the acute
treatment of migraine, is being developed by POZEN under an alliance
with GlaxoSmithKline.
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
Treximet(TM) which is currently under review by the United States Food
and Drug Administration for the acute treatment of migraine, and with
AstraZeneca for the proposed product candidate PN 400 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; our inability to know with certainty what
standards the FDA will use to evaluate drug candidates and how that
may change or evolve over time; 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; the receipt of future development, regulatory or
sales milestones and royalty payments from our collaboration partners;
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; and one-time events, including those
discussed herein and in our Quarterly Report on Form 10-Q for the
period ended September 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.
CONTACT: POZEN Inc.
Bill Hodges, 919-913-1030
Chief Financial Officer
or
Fran Barsky, 919-913-1044
Director, Investor Relations
SOURCE: POZEN Inc.
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