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POZEN Hits All Primary Endpoints in Second Phase III Pivotal Trial for
Trexima; NDA Submission Scheduled for 3Q 2005
CHAPEL HILL, N.C. April 21, 2005 - POZEN Inc. (NASDAQ: POZN),
announced today that it achieved statistical significance for all regulatory
endpoints for Trexima in the second of the two Phase III pivotal trials.
Trexima(TM) is GlaxoSmithKline's (GSK) proposed brand name for the
combination of sumatriptan formulated with RT Technology(TM) and naproxen
sodium in a single tablet. GSK and POZEN are collaborating on the
development of Trexima.
POZEN also announced that it has met with the FDA and discussed the results of
both Phase III trials and other information required for the submission of
the Trexima NDA. Based upon discussions at the pre-NDA meeting, POZEN
believes that no additional pre-clinical or clinical trials are necessary
for submission. The Trexima NDA submission is now scheduled for the third
quarter of 2005.
In the second Phase III study, Trexima demonstrated superiority over the
individual components on the primary endpoint and also met all the
regulatory endpoints for a new migraine product. For the combination,
Trexima demonstrated a superior sustained pain-free response versus naproxen
(p<0.001) and versus sumatriptan (p=0.009). With respect to pain relief and
the associated symptoms of nausea, photophobia, and phonophobia, Trexima was
superior to placebo at 2 hours for all parameters (p=0.007 for nausea,
p<0.001 for the others).
"We are obviously very pleased with the pre-NDA meeting resulting in our
ability to submit the Trexima NDA early in the second half of this year,"
said Dr. John R. Plachetka, Chairman, President and CEO. "The team has done
a remarkable job in completing the two pivotal studies in less than a year
from start to finish."
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. Since its inception, POZEN has
focused its efforts primarily on the development of pharmaceutical products
for the treatment of migraine. POZEN is also exploring the development of
product candidates in other pain-related therapeutic areas. POZEN has
development and commercial alliances with GlaxoSmithKline, Xcel
Pharmaceuticals, and Nycomed. 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; and one-time
events, including those discussed herein and in our annual report on Form
10-K for the year ended December 31, 2004 under "Management's Discussion and
Analysis of Financial Condition and Results of Operations." 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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