CHAPEL HILL, N.C., Oct 8, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced today that it has submitted a Marketing
Authorization Application to the Medicines Control Agency in the United Kingdom
for MT 100, an oral tablet designed for first-line migraine therapy.
Once approved in the U.K, POZEN will seek approval in other European countries
through the European Union Mutual Recognition Procedure with the U.K. acting as
the Reference Member State. The procedure allows other European countries to
grant national approvals based on recognition of the findings of the Medicines
Control Agency in the U.K.
"This submission marks an important first step in the evolution of migraine
care," said John R. Plachetka, Pharm.D., chairman, president, and chief
executive officer of POZEN. "The data submitted in this application demonstrates
that MT 100's dual action combination therapy produces excellent therapeutic
results. We believe MT 100 may represent the best entry-level therapy for
migraine sufferers and may provide a clear alternative to triptans, potent
agents that should be reserved for severe migraine attacks."
MT 100 is being developed as an oral, first-line treatment for migraine. POZEN
has completed all planned Phase III pivotal trials for MT 100, which has
consistently demonstrated the product candidate's effectiveness in treating
migraine pain and associated symptoms with less risk of cardiovascular side
effects than leading products on the market today. Based on the results from two
Phase III trials comparing MT 100 to the market leading product Imitrex(R) 50
mg, MT 100 is the first non-triptan to produce triptan-like efficacy.
According to a Datamonitor report published in May 2001, there are an estimated
37 million migraine sufferers in the five major European markets. Migraine is
characterized by recurring attacks of headache that are often accompanied by
nausea, and sensitivity to light and sound. In the most severe attacks, migraine
sufferers are unable to pursue basic daily activities. The average migraine
patient experiences attacks throughout his or her adult life.
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