CHAPEL HILL, N.C., Jul 22, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced the preliminary results from study MT
300-301, its first Phase III clinical study for MT 300.
The product candidate is designed to provide long-lasting pain relief for
patients needing a convenient injectable therapy for severe migraine attacks
with a reduced side-effect profile compared to existing injectable products. MT
300 is being developed as a new, improved formulation of dihydroergotamine (DHE)
in a convenient pre-filled syringe that is suitable for at-home use. Injectable
migraine products represented more than $200 million in 2001 U.S. sales.
MT 300-301 was a double-blind placebo-controlled study conducted in 619 patients
with acute migraine across 36 centers in the United States. The study compared
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.
Sustained response was defined as patients achieving pain relief within 2 hours
of dosing and neither relapsing nor using rescue medicine over the next 22
Preliminary analysis of the data indicated that the sustained response rate for
MT 300 was statistically superior to that for placebo, 37% versus 19% (p less
than 0.001). Furthermore, MT 300 provided pain relief in significantly more
patients at 2 and 4 hours compared to placebo (51% vs. 38% and 67% vs. 46%
respectively, both p less than 0.001). Regarding secondary endpoints, MT 300
provided statistically significant relief from photophobia by 2 hours, relief
from phonophobia by 3 hours and, in subjects with nausea at baseline, MT 300
provided statistically significant relief from nausea by 4 hours. Relief for
secondary symptoms remained superior to placebo at 24 hours.
The most commonly reported adverse event was injection site reaction in 35% of
the MT 300 subjects and 21% of the placebo subjects. Other adverse events
occurring in at least 5% of patients include dizziness (6% vs. 2%, MT 300 vs.
placebo), diarrhea (5% vs. 3%), nausea (5% vs. 2%), abdominal pain (5% vs. 1%),
and limb pain (5% vs. 1%).
The second Phase III trial for MT 300 is nearing completion and submission of
the NDA for MT 300 remains on schedule for the end of 2002.
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 $2.8 billion this year. The
company's common stock is traded on The Nasdaq Stock Market under the symbol
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 March 31, 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