If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Myotrophin New Drug Application Submitted to FDA for ALS WEST CHESTER, Pa., and EMERYVILLE, Calif., Feb. 11, 1997 -- Cephalon, Inc. (Nasdaq: CEPH) and Chiron Corporation (Nasdaq: CHIR) announced today that the two companies have submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking clearance to market Myotrophin(R) (rhIGF-1 or mecasermin (recombinant DNA origin)) Injection in the United States for the treatment of amyotrophic lateral sclerosis (ALS). The NDA contains findings from two double-blind, placebo-controlled Phase 3 clinical studies of 449 patients with ALS. The Phase 3 studies were designed to measure patients' signs and symptoms of ALS, overall well-being and health-related quality of life. ALS is a fatal neuromuscular disease characterized by the chronic, progressive deterioration of motor neurons. The term "amyotrophic" refers to muscle wasting or atrophy; "lateral sclerosis" refers to the scarring or degeneration of motor neurons that project from the lateral columns of the spinal cord to muscle tissue. It is the loss of these motor neurons that leads to muscle weakness, muscle atrophy and eventually death from respiratory failure. The FDA designated Myotrophin Injection an orphan drug for the treatment of ALS in 1991. Myotrophin Injection is currently being made available to a limited number of patients with ALS in the United States under a Treatment Investigational New Drug protocol approved by the FDA in June 1996. Cephalon and Chiron are developing Myotrophin Injection in North America and Europe for the treatment of ALS and other neuromuscular disorders, and are currently preparing applications for marketing approval in Canada and Europe. Chiron Corporation, headquartered in Emeryville, Calif., near San Francisco, is a science-driven healthcare company that combines diagnostic, vaccine, and therapeutic strategies for controlling disease. Chiron participates in four global markets; diagnostics, including immunodiagnostics, critical care diagnostics, and new quantitative probe tests; ophthalmic surgical products for the correction of vision; pediatric and adult vaccines; and therapeutics, with an emphasis on oncology and infectious diseases. Chiron also has research programs underway in gene therapy and gene transfer, combinatorial transfer, combinatorial chemistry, cardiovascular disease and critical care. Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical company that discovers, develops and markets products to treat neurological disorders. The company is developing products for the treatment of ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and spinal injury, and stroke, and currently copromotes two products in the United States for the treatment of neurological conditions. This news release may contain forward-looking statements that involve risks and uncertainties. A full discussion of the companies' operations and financial condition, including factors that may affect their business and future prospects, is contained in documents the companies file with the SEC, such as form 10-Q and 10-K reports. These documents identify important factors that could cause the companies' actual performance to differ from current expectations.
|
