|POZEN Confirms MT 100 Efficacy Equivalent to Market Leader|
CHAPEL HILL, N.C., Apr 11, 2002 /PRNewswire-FirstCall via COMTEX/ -- POZEN Inc. (Nasdaq: POZN) a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, announced that it successfully completed its second study comparing MT 100 to the leading migraine product in the U.S., Imitrex(R) 50 mg. 1,027 migraine patients completed this double-blind, placebo-controlled trial, which was conducted at 41 centers around the United States. The trial results indicate that a single tablet dose of MT 100 provided comparable efficacy to Imitrex(R) 50 mg. and was superior to placebo for both two hour pain relief and sustained pain relief, confirming the results of a previously completed Phase III trial. The FDA usually requires at least two studies with similar results to support promotional claims.
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 its effectiveness in treating migraine pain with less risk of cardiovascular side effects compared to leading products on the market today.
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. POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.6 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-K for the year ended December 31, 2001 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