|POZEN Inc. Commences Final MT 300 Phase III Trial|
Second Pivotal Trial to be Completed in Clinic During Second Quarter; MT 300 Development Timeline on Schedule
CHAPEL HILL, N.C., Jan 31, 2002 /PRNewswire-FirstCall via COMTEX/ --POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of candidates for the treatment of migraine, today announced that it has commenced the second and final planned Phase III pivotal trial for approval of MT 300, the company's injectable product candidate for the treatment of severe migraine. POZEN expects to complete this trial in the clinic during the second quarter and that data should be available during the third quarter.
MT 300 is a new, improved formulation of DHE in a convenient, pre-filled syringe that is suitable for at-home use. This double-blind and placebo- controlled trial will treat 400 patients, who suffer from acute migraine, at 30 centers in the United States. It is designed to compare the efficacy of MT 300 to placebo, with sustained pain response as the primary endpoint and nausea and sensitivity to light and sound as secondary endpoints.
MT 300's initial Phase III pivotal trial is expected to be completed in the clinic during the first quarter 2002, with data available in the second quarter. A total of 600 patients from 30 U.S. centers will be treated in this double-blind, placebo-controlled trial. The trial's primary endpoint is sustained pain response, with nausea and sensitivity to light and sound as secondary endpoints.
John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer, said, "One of our stated goals for 2002 was to commence this trial in the first quarter, and we based our other milestones for MT 300 on achieving this goal. By meeting this deadline, our development timeline, including filing a New Drug Application by the end of this year, remains on schedule."
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 MT 300 and our other products; costs and delays in the development of MT 300 and our other 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, 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