|POZEN Submits New Drug Application to the U.S. FDA for MT 100 for the Acute Treatment of Migraine|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--July 31, 2003--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced the submission today of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of MT 100(TM) for the acute treatment of migraine. The FDA has agreed to review the NDA and to accept POZEN's filing of the results of the rat carcinogenicity study in early 2004.
"In a recently published study for the National Headache Foundation, eight out of ten migraine sufferers said they would consider taking a new therapy with similar efficacy but fewer side effects than current prescription medicines. MT 100 is designed to fill this need, and if approved, may provide patients with an important new treatment option," said John R. Plachetka, president, chairman, and chief executive officer of POZEN. "This marks POZEN's third major regulatory submission in less than ten months and underscores our dedicated effort to make our product candidates available to the millions of migraine sufferers."
MT 100 is being developed as an oral first-line therapy for the treatment of migraine. In two large, well-controlled, head-to-head studies, MT 100 delivered comparable migraine relief to Imitrex(R) 50 mg, a triptan, and the leading prescription product for migraine. Inherent in MT 100's mechanism of action is a reduced risk of cardiovascular side effects compared to a class of drugs called triptans. More than 7,700 migraine patients were involved in Phase II, Phase III, and Phase IIIb trials for MT 100, and of those, more than 3,700 received some form of MT 100. Data from the trials have consistently shown MT 100's effectiveness in treating migraine pain.
In addition to the NDA submission to the FDA, POZEN announced on October 8, 2002, that it submitted a Marketing Authorization Application for MT 100 to the Medicines Control Agency in the United Kingdom. If approved in the U.K., POZEN will seek approval in selected European countries through the European Union Mutual Recognition Procedure.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. POZEN has development and commercialization alliances with GlaxoSmithKline and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, 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 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 March 31, 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.