|POZEN Reaches Agreement With FDA and MCA On MT 400 Development Program|
|CHAPEL HILL, N.C., Aug 1, 2002 (BW HealthWire) -- POZEN Inc. (Nasdaq: POZN), a
pharmaceutical development company with a portfolio of product candidates for
the treatment of migraine, announced that it had reached agreements with the
U.S. Food and Drug Administration (FDA) and the Medicines Control Agency (MCA)
of the United Kingdom on the development program for MT 400, the company's next
generation migraine therapy product candidate.
In the United States, the FDA approved POZEN's request to submit MT 400 as a 505(b)(2) application. In the United Kingdom, the MCA agreed to a similar development program. As part of the agreement, POZEN will not be required to complete chronic toxicology and carcinogenicity studies. The regulatory bodies also indicated that adequate information was available to select a dose, thereby eliminating the need for Phase II dose ranging trials.
"These agreements will significantly reduce our development costs for MT 400 and will allow us to proceed directly to Phase III clinical trials," said John R. Plachetka, Pharm.D. chairman, president and chief executive officer.
MT 400 combines a triptan with a long-acting non-steroidal, anti-inflammatory drug (NSAID) in a single tablet. In a previously completed Phase II clinical trial involving 972 patients, MT 400 showed a statistically significant superiority over placebo and its components on two-hour pain response and sustained pain relief, and showed effectiveness in the relief of migraine associated symptoms. Sustained pain relief was defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.
In addition, with respect to sustained pain relief, the therapeutic gain with MT 400 was more than twice the therapeutic gain seen with the triptan. Therapeutic gain was defined as the percent of patients with response on active agent minus the percent of patients with response on placebo control agent.
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 March 31, 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