Teva Shares Tumble After FDA Postpones MS Drug Ruling

The announcement of the US Food and Drug Administration's postponement of a ruling on marketing approval for Israeli firm Teva's multiple sclerosis drug Copaxone (copolymer-1) triggered a fall in the company's shares, both in New York and Tel Aviv, Israel. The FDA has said it will require Copaxone to go before an advisory committee. An earlier delay in approval occurred when the product was not included on the agenda of a previous advisory panel meeting (Marketletter May 20).

After the stock dropped over 9% on Wall Street to close at around $34.88, it fell 6% on trading of $1.57 million of shares on the Tel Aviv exchange. The company's chief executive, Dan Suesskind, said it was "exceptional" that the FDA had earlier decided to bypass its own advisory committee in the ongoing review procedure of the MS drug. Mr Suesskind added that he guessed it had now decided not to make an exception.

The company says the FDA has scheduled its Peripheral and Central Nervous System Drugs Advisory Committee to discuss the product in September. Teva filed its New Drug Application on Copaxone in June 1995, and some market watchers expected that approval would have been granted by now.