|POZEN to Submit MT 100 Mouse Carcinogenicity Study Results to FDA in Q1 2002|
CHAPEL HILL, N.C., Sept. 19 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, today announced that it plans to submit the results of the mouse carcinogenicity study in the first quarter of 2002, and continue discussions with the Food and Drug Administration (FDA) about the agency's request to submit the final rat carcinogenicity study report prior to approval of its New Drug Application (NDA). As of this time, the company has been unable to convince the FDA to change its January 2001 decision to require carcinogenicity studies in two species prior to NDA approval, despite the submission of new in vitro and in vivo genotoxicity data supporting the safety of MT 100. The company would not comment on when or if it will be successful in future discussions with the FDA, but acknowledged that the MT 100 NDA submission will not take place this year. The company also advised that a partnership deal for MT 100 may be postponed until closer to the expected NDA submission date.
"The results of the mouse carcinogenicity study will be available shortly," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN. "The mouse study completes the in-life portion in November this year and we are planning to send the final report of the study to the FDA in the first quarter of 2002. Theoretical arguments and the new genotoxicity data haven't moved the agency to our position yet, although the FDA has demonstrated some flexibility, such as allowing us to conduct the six-month P53 transgenic mouse carcinogenicity study instead of the standard 18-month study. We believe that submitting favorable mouse data and clinical data that demonstrates the advantages of MT 100 over current treatments indicated for migraine will go a long way to making the FDA comfortable with accepting the final report of the rat carcinogenicity study, which began last month, after NDA approval of MT 100."
POZEN believes that MT 100 is the only new migraine treatment providing efficacy equal to or better than the triptans, but without a vascular mechanism of action. The company knows of no products in development today with a similar profile to MT 100.
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; 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