ImClone and Bristol-Myers to seek FDA approval of Erbitux this year
NEW YORK, Jun 05, 2003 (The Canadian Press via COMTEX) -- ImClone Systems Inc. and Bristol-Myers Squibb Co. said Thursday they will use new data on the cancer drug Erbitux to resubmit an application to regulators this year to sell the drug in the United States.
Shares of both companies surged on the news, released late Thursday. In after-hours trading, ImClone was up $7.94 or 21 per cent to $46.47 US a share. Bristol-Myers, which owns 20 per cent of ImClone, gained five per cent, up $1.30 at $28.20.
Erbitux was at the centre of an insider-trading scandal that ensnared ImClone founder Sam Waksal and his friend, domestic design maven Martha Stewart.
If it is approved by the U.S. Food and Drug Administration, the drug could be on the market by early next year.
The companies' application to the FDA will include data from a 329-patient study conducted by ImClone's German partner, Merck KGaA, which showed that Erbitux shrank tumours in some colon cancer patients.
This finding was similar to a study ImClone submitted in its initial application to the FDA in December 2001. That application was rejected because the FDA considered the study sloppily done.
The rejection threw the stock into a tailspin and sparked an insider trading scandal that led Waksal to plead guilty to several charges including fraud.
Stewart was indicted Wednesday and resigned as chief executive of her media company, though she vowed to fight the charges.
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