First Approval Of Teva's MS Drug Copaxone

As mentioned briefly in last week's issue of the Marketletter, Teva Pharmaceutical Industries has been granted approval by the Israeli Ministry of Health for Copaxone (copolymer-1), its new drug for the treatment of relapsing-remitting multiple sclerosis. Copaxone is the first non-interferon product to be approved for the disorder.

Israel is the first country to approve Copaxone, and the company says it expects to launch the drug there before the end of the year. The company would not comment on pricing plans prior to the launch. Copaxone's approval is an important stage in Teva's bid to roll out the drug in international markets, as some of the other countries in which the dossier has been submitted require Israeli approval as a prerequisite for registration.

Copaxone is pending approval in the UK, Canada and USA, as well as certain other markets. In the USA, Teva has already received an approvable letter following a positive Food and Drug Administration advisory panel meeting, sparking feverish excitement amongst investors. If full approval comes, Teva will be the first Israeli company to earn US approval for a novel drug. The company hopes to secure UK approval in the next few months, opening the way for further European registrations under the mutual recognition process, with a view to having the product in European markets in mid-1997.