|POZEN Inc. Reaches Agreement With FDA to Submit Rat Carcinogenicity Study Results During MT 100 NDA Review Period|
Chapel Hill, N.C., Feb 20, 2002 /PRNewswire-FirstCall via COMTEX/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of candidates for the treatment of migraine, announced today that the Food and Drug Administration (FDA) has agreed to accept results from the company's ongoing rat carcinogenicity study during the New Drug Application (NDA) review period for MT 100, the company's lead product candidate. POZEN also confirmed that FDA approval of the MT 100 NDA is still dependent on the successful completion and review of two carcinogenicity studies.
Preliminary results of the first carcinogenicity study were submitted to the FDA earlier this month and the final report will be submitted in the next few weeks. Those preliminary results indicated that MT 100 was not carcinogenic in the test species, p53 transgenic mice. The in-life portion of the second study, an ongoing, two-year rat carcinogenicity study, will be complete in August 2003, with submission of the results to the FDA as soon as possible thereafter. Based on the company's latest discussions with the FDA, POZEN plans to submit its NDA for MT 100 in the first half of 2003.
MT 100 is being developed as an oral, first-line treatment for migraine pain and associated symptoms. The effectiveness of the product candidate has been demonstrated in numerous Phase II and Phase III clinical studies involving thousands of patients. Last year the company announced that MT 100 provided comparable efficacy with fewer side effects when tested against Imitrex(R), the worldwide market leader.
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 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 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 .