REHOVOT, ISRAEL -- September 19, 1996...An advisory committee convened by the U.S. Food and Drug Administration recommended today that the FDA approve the Israeli drug copolymer-1, to be marketed under the brand name COPAXONE (r) for treatment of patients with relapsing-remitting multiple sclerosis.
Following the recommendation, the FDA is expected to grant its approval for the marketing of the drug in the U.S. within the next few weeks.
Copolymer-1 (COPAXONE (r)) is a protein-like molecule originally synthesized by Prof. Michael Sela, Prof. Ruth Arnon and Dr. Dvora Teitelbaum of the Weizmann Institute of Science in Rehovot, Israel. Yeda Research & Development Co., which deals with the commercialization of Weizmann Institute research, granted exclusive rights for manufacturing and for marketing copolymer-1 (COPAXONE (r) throughout the world to Teva Pharmaceutical Industries Ltd. The drug was further developed by Teva, with the participation of physicians and researchers from Israel and other countries.
Clinical trials carried out in recent years have shown that copolymer-1 reduces the number of attacks in patients with the relapsing-remitting form of multiple sclerosis, and that it ameliorates the condition of people in the early stages of this disease. Moreover, the drug produces almost no negative side effects.
Copolymer-1 (COPAXONE (r)) was first clinically investigated at the Hadassah - Hebrew University Medical Center in Jerusalem and the Albert Einstein College of Medicine in New York, and follow-up trials were conducted at various other research centers. In a decisive double-blind trial carried out between 1991 and 1994, copolymer-1 was tried on several hundred patients in eleven U.S. hospitals. Following the success of these trials, a request for a marketing approval for the drug was filed last year with the FDA, and, as noted above, a recommendation for such an approval has just been granted.
Multiple sclerosis is an autoimmune disease that occurs when the body's immune system erroneously attacks the protective myelin coating around nerve fibers in the central nervous system. Once this coating is destroyed, signals sent along these nerves are slowed down, and at times stopped altogether. As a result, body movement becomes difficult, and partial or complete paralysis may set in.
Copolymer-1 (COPAXONE (r)) blocks this process in two ways it prevents the immune-system "attacker" cells from recognizing the myelin coating, thus warding off their attack, and it also triggers the production of immune-system suppressor cells that inhibit the action of the destructive attackers.
Multiple sclerosis is a devastating disease affecting mainly young people approaching the prime of their lives. Approximately 1 million people suffer from it around the world, including some 300,000 patients in the US and additional 350,000 in Europe.
Prof. Arnon holds the Paul Ehrlich Chair of Immunology and Prof. Sela, the W. Garfield Weston Chair of Immunology.
The Weizmann Institute of Science, in Rehovot, Israel, is one of the world's foremost centers of scientific research and graduate study. Its 2,400 scientists, students, technicians, and engineers pursue basic research in the quest for knowledge and the enhancement of the human condition. New ways of fighting disease and hunger, protecting the environment, and harnessing alternative sources of energy are high priorities.
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