Chapel Hill, N.C., Feb 20, 2002 /PRNewswire-FirstCall via COMTEX/ -- POZEN Inc.
(Nasdaq: POZN), a pharmaceutical development company with a portfolio of
candidates for the treatment of migraine, announced today that the Food and Drug
Administration (FDA) has agreed to accept results from the company's ongoing rat
carcinogenicity study during the New Drug Application (NDA) review period for MT
100, the company's lead product candidate. POZEN also confirmed that FDA
approval of the MT 100 NDA is still dependent on the successful completion and
review of two carcinogenicity studies.
Preliminary results of the first carcinogenicity study were submitted to the FDA
earlier this month and the final report will be submitted in the next few weeks.
Those preliminary results indicated that MT 100 was not carcinogenic in the test
species, p53 transgenic mice. The in-life portion of the second study, an
ongoing, two-year rat carcinogenicity study, will be complete in August 2003,
with submission of the results to the FDA as soon as possible thereafter. Based
on the company's latest discussions with the FDA, POZEN plans to submit its NDA
for MT 100 in the first half of 2003.
MT 100 is being developed as an oral, first-line treatment for migraine pain and
associated symptoms. The effectiveness of the product candidate has been
demonstrated in numerous Phase II and Phase III clinical studies involving
thousands of patients. Last year the company announced that MT 100 provided
comparable efficacy with fewer side effects when tested against Imitrex(R), the
worldwide market leader.
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 100 and our other
products; costs and delays in the development of MT 100 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