|POZEN Inc. Receives FDA Request for Additional MT 100 Carcinogenicity Studies|
CHAPEL HILL, N.C., Jan. 26 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, announced that the Food and Drug Administration (FDA) has requested additional carcinogenicity studies for MT 100, the company's late Phase III migraine treatment. POZEN had requested a complete waiver of any carcinogenicity studies.
According to POZEN, MT 100 is a combination product of two approved drugs, metoclopramide HC1 and naproxen sodium. Both agents have been in clinical use for over 20 years in the United States and are approved for indications outside of migraine in the United States and countries around the world. The FDA has agreed to consult with the company on appropriate models and study designs.
"We hope to work with the FDA on a package of appropriate studies that will allow us to maintain our timeline for New Drug Application submission," said John R. Plachetka, Pharm. D., chairman, president and chief executive officer of POZEN. "However, it may take a few months to learn if a package is feasible and if it is not, our time to market for MT 100 will be delayed by at least 18 months."
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; unanticipated 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 Registration Statement filed on Form S-1 (File No. 333-35930) under "Business" or " Risk Factors." 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 .