CHAPEL HILL, N.C., Sep 5, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN)
announced today results of a Phase III study designed to evaluate the safety of
MT 100 in migraine patients over a one-year period.
Results of the study indicated that MT 100 was well tolerated. MT 100 is an oral
tablet designed for first-line migraine therapy.
More than 1,000 patients across 54 centers in the U.S. participated in the
study. A total of 23,195 migraine attacks were treated with a single tablet dose
of MT 100. Results of the study showed that only 8% of the patients discontinued
the study because of an adverse event including fatigue, somnolence,
restlessness, anxiety and diarrhea. No patients discontinued the study because
of chest pain or discomfort. Although efficacy was not an endpoint of the study,
only 15% of the patients discontinued the study because MT 100 did not provide
adequate migraine symptom relief.
"These data support the intended use of MT 100 as first-line therapy and
demonstrate that it is well tolerated," said John R. Plachetka, Pharm.D.,
chairman, president and chief executive officer of POZEN. "We are very pleased
with the results of the study which, in a practical real life setting such as
this, suggests that MT 100 may provide effective migraine therapy."
POZEN is a pharmaceutical development company committed to building a portfolio
of products with significant commercial potential in select therapeutic areas.
POZEN's initial focus is on developing products for migraine therapy, a global
market expected to exceed $2.8 billion this year. The company's common stock is
traded on The Nasdaq Stock Market under the symbol "POZN."
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 products; costs and
delays in the development and FDA approval of our products; our inability to
enter into or maintain, and the risks resulting from our dependence upon,
collaboration or contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution of our
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 our 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 quarterly period ended June 30, 2002 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.
POZEN is on the Internet at www.pozen.com
Chief Financial Officer
Director, Investor Relations