The FDA refused to review the new drug application(NDA) of Teva Pharmaceutical Industries Ltd. for itsmultiple sclerosis drug, Copaxone, but analysts saidTuesday the setback appears temporary.

Teva, of Jerusalem, said the FDA sent the company a"refuse-to-file" letter requesting additional informationbefore the regulatory agency would review Copaxone formarket approval. The FDA is seeking details aboutquality controls in manufacturing the drug.

Teva officials said Tuesday they have supplied theinformation and expect to meet with the FDA within 10days.

"We don't think this is a big deal," said Kenneth Nover,an analyst with A.G. Edwards & Sons Inc. in St. Louis."If any time is lost in the short term in the NDA reviewprocess, that time should be made up later in theprocess."

Teva disclosed receipt of the FDA's letter after themarket closed Monday. The company's stock(NASDAQ:TEVIY) Tuesday dropped 63 cents to $39.13.

The FDA's concerns about Copaxone apparently did notinvolve the drug's "safety, efficacy or clinical trials,"Nover said.

Teva filed the Copaxone NDA in June. The company hasa U.S. and Canada marketing agreement for the drug withGermany-based Hoechst AG's pharmaceutical division,Hoechst Marion Roussell.

Copaxone is expected to compete with two other multiplesclerosis drugs, both versions of beta interferon.Emeryville, Calif.-based Chiron Corp.'s Betaseronalready is on the U.S. market and Biogen Inc., ofCambridge, Mass., filed its NDA for Avonex in May.

Multiple sclerosis, a neurological disease, is caused bydamage to the myelin sheath, which insulates nerve fibersthat transmit electrical impulses. Copaxone, or co-polymer 1, is a four-amino acid peptide fragment derivedfrom myelin basic protein, which is the antigen thought totrigger the autoimmune response responsible for thedisease.

Although researchers don't know how Copaxone works,they believe it may help prevent destruction of the myelinsheath. n

-- Charles Craig

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