CHAPEL HILL, N.C., Jan. 26 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced that the Food and Drug Administration
(FDA) has requested additional carcinogenicity studies for MT 100, the
company's late Phase III migraine treatment. POZEN had requested a complete
waiver of any carcinogenicity studies.
According to POZEN, MT 100 is a combination product of two approved drugs,
metoclopramide HC1 and naproxen sodium. Both agents have been in clinical use
for over 20 years in the United States and are approved for indications
outside of migraine in the United States and countries around the world. The
FDA has agreed to consult with the company on appropriate models and study
"We hope to work with the FDA on a package of appropriate studies that
will allow us to maintain our timeline for New Drug Application submission,"
said John R. Plachetka, Pharm. D., chairman, president and chief executive
officer of POZEN. "However, it may take a few months to learn if a package is
feasible and if it is not, our time to market for MT 100 will be delayed by at
least 18 months."
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. The company's initial focus is
migraine, where it has built a robust portfolio of four product candidates
through a combination of innovation and in-licensing. 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; unanticipated 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 Registration Statement filed on Form S-1 (File No. 333-35930) under
"Business" or " Risk Factors." We do not intend to update any of these
factors or to publicly announce the results of any revisions to these forward-
POZEN is on the Internet at www.pozen.com .
Matthew E. Czajkowski
Chief Financial Officer of POZEN Inc.
Doug Broderick of The Financial Relations