- The Washington Times - Thursday, May 23, 2002

Embattled ImClone Systems Inc. founder and Chief Executive Samuel Waksal resigned yesterday, three days after disappointing clinical trial results for a promising cancer drug dealt the biotech company its latest in a string of setbacks.
The company late yesterday promoted his brother Harlan, who had been chief operating officer, as his successor at the company, which developed the experimental cancer-fighting drug Erbitux.
"In light of recent events and the distractions they have caused, I am withdrawing myself from the daily operation of the company," said Samuel Waksal, who helped start the New York firm 18 years ago.
The resignation came three days after disappointing results of clinical trials of Erbitux were released at the annual American Society of Clinical Oncology meeting in Orlando, Fla.
Sources close to the company said Mr. Waksal felt his credibility under fire since federal regulators refused to consider Erbitux's approval application in December could not be separated from the company's fortunes.
Earlier yesterday, ImClone and Bristol-Myers Squibb Co. said they will begin new human trials of Erbitux in their continued bid to win regulatory approval for the drug.
That news ended a week's worth of bad news and two days of sharp stock declines for ImClone.
The company's shares rose 78 cents, or 7.7 percent, to close yesterday at $10.90 on Nasdaq. Bristol-Myers' stock rose 79 cents, or 2.6 percent, to close at $30.88 a share on the New York Stock Exchange.
After the announcement of the management shake-up, ImClone stock gained 65 cents, or nearly 6 percent, to reach $11.55 in after-hours trading.
ImClone's stock had plunged more than 25 percent earlier in the week after the embattled Erbitux received two more setbacks.
On Sunday, ImClone said results from an Erbitux clinical trial in head and neck cancer patients were disappointing. Last week, ImClone's German partner, Merck KGaA, declined a request to increase the number of patients in its European Erbitux trial on colorectal cancer patients.
ImClone asked Merck for the modification so it would have more data to minimize the delay in filing its next application to gain Food and Drug Administration approval.
The FDA rejected ImClone's Erbitux application last year, but earlier this year said it would consider data from the European trial when it re-examines the drug.
Bristol had agreed to pay $2 billion for 20 percent of ImClone and 40 percent of Erbitux's revenues. The deal was modified this year after Bristol demanded new terms and wrote off $735 million of its investment because of ImClone's declining stock price.

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