|POZEN Submits Marketing Authorization Application in the United Kingdom for MT 100; Marketing Applications in Other European Countries to Follow Pending Approval in the U.K.|
|CHAPEL HILL, N.C., Oct 8, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced today that it has submitted a Marketing
Authorization Application to the Medicines Control Agency in the United Kingdom
for MT 100, an oral tablet designed for first-line migraine therapy.
Once approved in the U.K, POZEN will seek approval in other European countries through the European Union Mutual Recognition Procedure with the U.K. acting as the Reference Member State. The procedure allows other European countries to grant national approvals based on recognition of the findings of the Medicines Control Agency in the U.K.
"This submission marks an important first step in the evolution of migraine care," said John R. Plachetka, Pharm.D., chairman, president, and chief executive officer of POZEN. "The data submitted in this application demonstrates that MT 100's dual action combination therapy produces excellent therapeutic results. We believe MT 100 may represent the best entry-level therapy for migraine sufferers and may provide a clear alternative to triptans, potent agents that should be reserved for severe migraine attacks."
MT 100 is being developed as an oral, first-line treatment for migraine. POZEN has completed all planned Phase III pivotal trials for MT 100, which has consistently demonstrated the product candidate's effectiveness in treating migraine pain and associated symptoms with less risk of cardiovascular side effects than leading products on the market today. Based on the results from two Phase III trials comparing MT 100 to the market leading product Imitrex(R) 50 mg, MT 100 is the first non-triptan to produce triptan-like efficacy.
According to a Datamonitor report published in May 2001, there are an estimated 37 million migraine sufferers in the five major European markets. Migraine is characterized by recurring attacks of headache that are often accompanied by nausea, and sensitivity to light and sound. In the most severe attacks, migraine sufferers are unable to pursue basic daily activities. The average migraine patient experiences attacks throughout his or her adult life.
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 $2.8 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 June 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.