|POZEN's Second Pivotal Study for MT 300 Hits Primary But Not Secondary Endpoints|
|CHAPEL HILL, N.C., Oct 4, 2002 (BUSINESS EDITORS) -- POZEN Inc. (Nasdaq:POZN),
a pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced the results from its second Phase III
clinical study for MT 300. MT 300 is the company's injectable product candidate
for the treatment of severe migraine.
The study compared the efficacy of MT 300 to placebo, with sustained pain relief as the primary endpoint and nausea and sensitivity to light and sound as secondary endpoints. Sustained pain relief was defined as patients achieving pain relief within 2 hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours. The double-blind placebo-controlled study treated 610 patients with acute migraine. The data for 550 patients was evaluated for efficacy, after excluding the efficacy data from one of the sites that failed to follow the study protocol.
The analysis of the data indicated that MT 300 provided sustained pain relief and pain relief at 2 hours in statistically significantly more patients than placebo (34% vs. 21% and 48% vs. 36%, respectively). MT 300 was not statistically superior to placebo for the secondary symptoms of migraine over the 2-hour post dose period. Further analysis of the data indicated that a statistically significantly greater number of patients treated with MT 300 than placebo had sustained relief of sensitivity to light (26% vs. 17%) and sound (33% vs. 24%) and the difference between MT 300 and placebo in the sustained relief of nausea was marginally statistically significant (36% vs. 29%; p=0.075).
The most commonly reported adverse event in this second pivotal study with MT 300 was injection site reaction in 30% of the MT 300 subjects and 22% of the placebo subjects. Other adverse events with MT 300 and placebo included dizziness (5% vs. 3%), diarrhea (4% vs. 1%), nausea (3% vs. 1%), abdominal pain (3% vs. less than 1%), and limb pain (3% vs. less than 1%).
POZEN has proposed to the Food and Drug Administration (FDA) that a sustained relief analysis of the secondary symptoms of migraine is a more clinically meaningful analysis than simply an assessment of a symptom at an isolated time point, and is consistent with the analysis that the FDA has accepted for migraine pain. Analyses of the secondary symptom data from the first pivotal Phase III study and of the combined database from the two pivotal Phase III studies indicate that statistically significantly more patients have a sustained relief of nausea, sensitivity to light and sound following treatment with MT 300 than with placebo.
MT 300 is designed to provide long-lasting pain relief for patients needing a convenient injectable therapy for severe migraine attacks with a reduced side-effect profile compared to existing injectable products. MT 300 is being developed as a new, improved formulation of dihydroergotamine (DHE) in a convenient pre-filled syringe that is suitable for at-home use. DHE has been used to treat migraine for more than 50 years and, prior to the introduction of injectable triptans, was the "gold standard" of injectable anti-migraine products. Injectable migraine products represented more than $200 million in 2001 U.S. sales.
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