How it began
In 1968 Ruth Arnon, Michael Sela and Dvora Teitelbaum of the Weizmann Institute of Science synthesized several copolymers that mimic a component of myelin, the protective coating of nerves. Because that component was believed to trigger multiple sclerosis, they hoped the molecules would produce an MS-like disease in animals for study. The copolymers failed to do so. In 1971 the scientists found the opposite effect: several of the copolymers blocked the MS-like disease in animals. Patent applications for copolymer 1, or Cop 1, were filed in Israel and other countries between 1972 and 1974.
How it works
Copolymer 1 is a copolymer of amino acids built to resemble part of myelin. In laboratory animals it suppressed experimental autoimmune encephalomyelitis, the animal disease used as a model of multiple sclerosis, and it did so in several species. The Weizmann scientists showed that it did not depress the entire immune system indiscriminately. After the drug was licensed, they continued research to clarify its mechanism of action.
How it spread
Teva submitted the file on Cop 1 to the US Food and Drug Administration on June 14, 1995. On December 23, 1996, the agency approved it under the name Copaxone for patients with MS, after nearly three decades of research. The Weizmann Institute described it as one of the first Israeli medications to receive FDA approval.
Who pushed back
The first clinical trial took place in 1977 at the Hadassah-Hebrew University Medical Center in Jerusalem, where four patients in the terminal stages of the disease received Cop 1 without major side effects. From 1978 to 1981 the scientists struggled to persuade clinicians to run larger trials. Arnon called it the peddling period: she presented the data at almost any conference on MS. Two physicians responded, Helmut Bauer in Gottingen and Murray Bornstein at the Albert Einstein College of Medicine in New York.
What changed first
Bornstein ran a double-blind study with fifty patients that lasted more than three years. Its results, published in the New England Journal of Medicine in 1987, showed that Cop 1 reduced the number of attacks in patients with relapsing-remitting MS with minimal side effects. In the same year the compound was licensed to Teva Pharmaceutical Industries of Israel, which began commercial development and later ran a trial at 11 medical centers in the United States.
