|POZEN Inc. Completes MT 100 Phase III Trials in Clinic; MT 400 Phase II Trial Begins|
CHAPEL HILL, N.C., Nov. 28 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of candidates for the treatment of migraine, today announced that two late-stage Phase III clinical trials for its lead product candidate, MT 100, have been completed. Data from these clinical trials will be available during the first quarter of 2001. The company also announced that a Phase II clinical trial for another product candidate, MT 400, has commenced.
MT 100 is an oral, first-line treatment for migraine pain and associated symptoms. Data in clinical trials to date indicate that MT 100 provides rapid and sustained migraine relief with minimal side effects.
One of the clinical trials completed compared MT 100 to its components. It was a 70-center, seven-month study with 2,500 patients. According to POZEN, if the results of this trial are statistically significant, the company will have satisfied the FDA requirement for successful completion of two Phase III clinical trials comparing MT 100 to its components.
The other clinical trial was a Phase III open-label, long-term safety study for MT 100 initiated in October 1999. The company's goal was to treat over 300 patients for six months and over 100 patients for one year at approximately 40 study sites. Instead, POZEN treated over 500 patients for six months and over 200 for one year.
MT 100 Development On Schedule
"The completion of these two clinical trials is a very important development for the company," said John R. Plachetka, Pharm.D., POZEN's president and chief executive officer. "We targeted completion of these studies in this year's fourth quarter and based our other milestones for MT 100 on this timeline, including filing a New Drug Application (NDA) by the end of 2001. Because we met this goal, our development timeline remains on schedule."
Plachetka also noted that the completion of these studies demonstrated that POZEN's model for developing drugs can accelerate time-to-market. "This year, over 4,000 patients were treated at over 120 clinical sites. These are huge numbers, and I am proud to say we managed the process very well. For both clinical trials, we had rapid enrollment, low drop out and a shorter-than-average study duration."
First IND Study for MT 400 Could Become Pivotal Trial
POZEN also announced that it commenced a Phase II clinical trial for MT 400, a proprietary product concept combining a triptan drug with a long-acting, non-steroidal anti-inflammatory agent, which is designed to provide faster and more sustained release for migraine sufferers. Recently, the FDA approved the company's Investigational New Drug (IND) application for a Phase II clinical trial of MT 400. The clinical portion of the trial, recruiting and treating 800 patients from 35 study sites, is expected to be completed within six months. Clinical trial supplies have been shipped and the company expects the first patient to be treated by early December.
Plachetka said, "When we received written approval for the IND in October, the FDA suggested that we use sustained response as our primary endpoint. This is the same endpoint we used for both MT 100 and MT 300, and we are heartened by the fact that the FDA considers this to be a definitive endpoint. This change necessitated an increase in sample size, meaning the clinical trial will now become a pivotal trial as well as a proof-of-concept trial, depending on the outcome."
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. The company's initial focus is migraine, where it has built a robust portfolio of four product candidates through a combination of innovation and in-licensing. 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 100 and our other products; unanticipated costs and delays in the development of MT 100 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 Registration Statement filed on Form S-1 (File No. 333-35930) under "Business" or " Risk Factors." 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 .