To: TokyoMex who wrote (17013 ) 5/12/1998 8:50:00 PM From: Eski Read Replies (1) | Respond to of 34592
WEST CHESTER, Pa. and EMERYVILLE, Calif., May 12 /PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH) and Chiron Corporation (Nasdaq: CHIR) announced today that the U.S. Food and Drug Administration (FDA) has indicated that the companies' new drug application (NDA) to market MYOTROPHIN(R) (mecasermin) Injection in the United States for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) is "potentially approvable", subject to submission of additional information from ongoing studies which demonstrates that MYOTROPHIN is effective in the treatment of ALS. In response to the FDA's letter, Frank Baldino, Jr., Ph.D., president and chief executive of Cephalon, and Lewis T. Williams, M.D., Ph.D., president of Chiron Technologies, stated: "We plan to meet with the FDA to clarify the conditions for approval and to determine whether these conditions can be satisfied." Chiron Corporation, headquartered in Emeryville, Calif., is a leading biotechnology company that participates in three global healthcare markets: diagnostics, vaccines and therapeutics. Chiron also conducts research and development in the fields of biological proteins, gene therapy and combinatorial chemistry. Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical company that discovers, develops and markets products to treat neurological disorders. This news release may contain forward-looking statements that involve risks and uncertainties. A full discussion of Cephalon's and Chiron's operations and financial condition, including factors that may affect the companies' business and future prospects, is contained in documents the two companies file with the SEC, such as form 10-Q and 10-K reports. These documents identify important factors that could cause their actual performance to differ from current expectations. Furthermore, there can be no assurance that the FDA's conditions for approval of MYOTROPHIN can be satisfied by the companies at all or in a reasonable time frame.