|POZEN Inc. Announces Positive Phase II Results for MT 400|
|Company's Third Product in Late-Stage Development for
Acute Migraine Treatment
Chapel Hill, N.C., May 21, 2001—POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, today announced the positive results from a 972-patient, Phase II double-blind, placebo-controlled clinical trial with MT 400, its third product candidate being developed for the acute treatment of migraine.
In the clinical trial, MT 400 was significantly better than placebo with respect to the primary endpoint, sustained pain relief, and the secondary endpoints, including relief of pain, nausea, sensitivity to light, and sensitivity to sound, two hours after dosing. All results were statistically significant beyond the p<0.001 level versus placebo. Significant pain relief (p<0.001) with MT 400 was seen between 30 and 45 minutes after dosing and was maintained throughout the remaining 24-hour post-dose period.
MT 400 was also superior to the oral triptan comparator included in the study as a positive control. At the present time, triptans such as Imitrex®, Zomig®, and Maxalt® are considered “the gold standard” of oral treatments for acute migraine attacks. With respect to the primary endpoint, sustained pain relief, the therapeutic gain with MT 400 was more than twice the therapeutic gain seen with the triptan (p<0.001). Therapeutic gain is equal to the percent of patients with response on active agent minus the percent of patients with response on placebo control agent.
MT 400 also provided superior efficacy versus the triptan with respect to the total number of patients with pain relief at two hours (72 percent more therapeutic gain, p<0.001) and the number of patients made pain free at two hours (more than twice as much therapeutic gain, p<0.001). Significant differences favoring MT 400 were also seen in other secondary migraine symptoms such as relief of sensitivity to light and sound. MT 400 was well tolerated throughout the trial.
“MT 400 has met all our expectations. Although this is only a single double-blind, well-controlled clinical trial, the database is large, robust and compelling,” said John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer. “However, Phase II results do not necessarily predict the eventual outcomes of Phase III trials and we have substantial work to complete before this product is ready for a New Drug Application to the Federal Drug Administration.
“Based on our clinical trial data, we believe that MT 400, and our other acute treatment product candidates, MT 100 oral tablets and MT 300 injection, will be excellent complementary products for migraine patients. Each has a unique profile, which will allow physicians and patients the opportunity to customize their treatment strategy once these product candidates reach the market,” Dr. Plachetka said.
“POZEN is the only company with a portfolio of well-differentiated product candidates that allows this patient-friendly approach. Our marketing research indicates that both physicians and patients really like the profiles of these product candidates and, because of that, we think that they have the potential to generate substantial revenue in the marketplace.”
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 inability to obtain a triptan for use in MT 400; our failure to successfully commercialize MT 100 and our other products; 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 Annual Report on Form 10-K/A 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