|POZEN's New Drug Application for MT 300 for the Acute Treatment of Migraine Accepted for Filing by FDA|
|CHAPEL HILL, N.C., Mar 13, 2003 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced today that its New Drug Application (NDA)
for MT 300 has been accepted for filing by the U.S. Food and Drug Administration
Filing acceptance occurs when the FDA determines that all of the required elements necessary for a complete review have been included in the application.
POZEN submitted its NDA on December 17, 2002, seeking marketing approval in the U.S. for MT 300 for the acute treatment of migraine. MT 300 is being developed as a new, improved product containing dihydroergotamine mesylate (DHE) in a convenient, easy to use pre-filled syringe.
"We believe MT 300 has the potential to become an important new product for patients who need or want a convenient injectable therapy for their migraine attacks", said John R. Plachetka, Pharm.D., chairman, president, and chief executive officer of POZEN. "The filing acceptance represents an important step toward our ultimate goal of achieving FDA approval and making MT 300 available to migraine sufferers."
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 $3 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 September 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