Second Pivotal Trial to be Completed in Clinic During Second Quarter; MT 300 Development Timeline on Schedule
CHAPEL HILL, N.C., Jan 31, 2002 /PRNewswire-FirstCall via COMTEX/ --POZEN Inc.
(Nasdaq: POZN), a pharmaceutical development company with a portfolio of
candidates for the treatment of migraine, today announced that it has commenced
the second and final planned Phase III pivotal trial for approval of MT 300, the
company's injectable product candidate for the treatment of severe migraine.
POZEN expects to complete this trial in the clinic during the second quarter and
that data should be available during the third quarter.
MT 300 is a new, improved formulation of DHE in a convenient, pre-filled syringe
that is suitable for at-home use. This double-blind and placebo- controlled
trial will treat 400 patients, who suffer from acute migraine, at 30 centers in
the United States. It is designed to compare the efficacy of MT 300 to placebo,
with sustained pain response as the primary endpoint and nausea and sensitivity
to light and sound as secondary endpoints.
MT 300's initial Phase III pivotal trial is expected to be completed in the
clinic during the first quarter 2002, with data available in the second quarter.
A total of 600 patients from 30 U.S. centers will be treated in this
double-blind, placebo-controlled trial. The trial's primary endpoint is
sustained pain response, with nausea and sensitivity to light and sound as
John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive
officer, said, "One of our stated goals for 2002 was to commence this trial in
the first quarter, and we based our other milestones for MT 300 on achieving
this goal. By meeting this deadline, our development timeline, including filing
a New Drug Application by the end of this year, remains on schedule."
North Carolina-based POZEN Inc. 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 $2.6 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 MT 300 and our other
products; costs and delays in the development of MT 300 and our other 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 September 30, 2001 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, of POZEN
Kathy Brunson of FRB Weber Shandwick