Teva Pharmaceutical Industries Inc. Thursday filed a new drugapplication (NDA) with the FDA for approval of Copaxone formultiple sclerosis.
Teva's NDA followed by a month Biogen Inc.'s submission for FDAapproval of its multiple sclerosis treatment, beta interferon, which iscalled Avonex.
If the FDA approves the two drugs, there would be three multiplesclerosis therapies on the U.S. market. Chiron Corp., of Emeryville,Calif., and its partner, Germany-based Schering AG, sell Betaseron, abeta interferon product, for treatment of the neurological disease.
In March, Teva, of Jerusalem, signed an agreement with MarionMerrell Dow, of Kansas City, Mo., to market Copaxone in the U.S.The subsequent $7.1 billion acquisition of Marion Merrell byGermany-based Hoechst AG in May was not expected to affect theTeva deal.
Multiple sclerosis is caused by damage to the myelin sheath, whichinsulates nerve fibers that transmit electrical impulses. Copaxone, orco-polymer 1, is a four-amino acid peptide fragment derived frommyelin basic protein, which is the antigen thought to trigger theautoimmune response that causes the disease.
Although researchers don't know how Copaxone works, they believeit may help prevent destruction of the myelin sheath.
Teva said it expects to submit Copaxone for approval in Europe andIsrael later this year. The company's stock (NASDAQ:TEVIY)closed Thursday at $35.69, up 56 cents._ Charles Craig
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