|POZEN'S New Drug Application for MT 100 for the Treatment of Migraine Accepted for Filing by FDA|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 7, 2003--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced today that its New Drug Application (NDA) for MT 100 for the acute treatment of migraine has been accepted for filing by the U.S. Food and Drug Administration (FDA). MT 100 is being developed as an oral first-line therapy for the treatment of migraine.
POZEN submitted its NDA for MT 100 on July 31, 2003, seeking marketing approval in the U.S. The FDA has agreed to review the NDA and to accept POZEN's filing of the results of a rat carcinogenicity study in early 2004. In accordance with the Prescription Drug User Fee Act (PDUFA), POZEN expects to receive initial FDA action in June 2004, approximately 10 months after the NDA submission date.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel, and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
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 product candidates; costs and delays in the development and/or FDA approval of our product candidates, resulting in, among other things, our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any 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 any 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 June 30, 2003 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.