Teva To File COP-1 NDA In Late 1994/Early 1995

31 July 1994

Teva has announced that it has completed its Phase III trials program for its multiple sclerosis treatment Copaxone (copolymer-1 or COP-1). The compound, which is classified as an Orphan Drug in the USA, is intended for use as a treatment for the exacerbating/ remitting form of the disease. It is estimated that there are approximately 100,000 sufferers of this type of MS in the USA and an additional 300,000 in the rest of the world.

COP-1 is a synthetic biochemical substance which is similar in structure to myelin basic protein. The drug is thought to act as a decoy to locally-produced autoimmune antibodies, binds to them and then attaches to and neutralizes the aberrant T-cell lines.

The results of this trial are sufficiently compelling to indicate that the company may be in a position to file a New Drug Application with the US Food and Drug Administration by the end of this year or early next, according to Teva chief executive Eli Hurvitz. Simultaneous applications will also be made in Europe and Israel, he noted.

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