The Drug That Could Have Been
When a young company called ImClone said it had a hot new cancer drug, its stock leapt on the bet that it would get an OK from the FDA. Now the stock has tanked, ImClone's charismatic CEO is indicted, and, Martha Stewart is in trouble, too. But the big losers are cancer victims. Here's the real story behind ImClone and why it failed to win the FDA's approval
THE COMPANIES
Harlan Waksal (above left), now CEO of ImClone, talks with his clinical trials chief, Michael Needle. The likelihood of ImClone's drug Erbitux being approved caught the attention of Bristol-Myers Squibb, which struck a $2 billion deal with ImClone. But Bristol-Myers Senior Vice President Laurie Smaldone (right) expressed her doubts. At far right: friends Sam Waksal and Martha Stewart at Lincoln Center in New York.
The rise and fall of a hot prospect
ImClone's stock price hinged on the chance that its cancer drug, Erbitux, would get FDA approval. Investors made and lost millions by taking that bet.
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March 6, 2000
Stock price peaks at $84.56 on the buzz that ImClone has a new drug
Aug. 11, 2000
ImClone's first meeting with the FDA
May 12, 2001
ImClone's study makes big news at conference
Sept. 19, 2001
Bristol-Myers Squibb announces deal with ImClone
Dec. 28, 2001
FDA faxes refusal letter to ImClone
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THE REGULATORS
Richard Pazdur, an FDA division chief, says the Erbitux matter could have been handled better. Patricia Keegan (center), supervisor of the Erbitux application review team, tried to work with ImClone officials. But Susan Jerian, on Keegan's team, remained skeptical that ImClone's studies would pass muster.
THE PATIENT
Rita Essigmann, an 81-year-old colon cancer patient, travels each week to Boston where she is enrolled in a cancer trial. Patients not enrolled in such trials, however, cannot get Erbitux.
With Pamela Sherrid and Katherine Hobson
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