Word: erbitux
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Dates: during 2000-2009
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...executives that dwarfed Stewart's $228,000 sale. And their trading preceded Stewart's by weeks, starting just after Food and Drug Administration (FDA) officials met privately with an ImClone vice president last Dec. 4 and informally signaled there could be licensing problems for the company's cancer drug Erbitux. The FDA formally turned down a review of the drug on Dec. 28, a day after Stewart traded her shares...
...with veto power over internal stock trading, has become a central focus of investigators, sources tell Time. On the night of Dec. 26, he spent 17 minutes on the phone with CEO Sam Waksal, records show. Waksal had just learned that the FDA would announce its negative decision on Erbitux in two days. Later that night Waksal drafted a note, marked "Urgent--Immediate Attention Required," to his Merrill Lynch broker, Peter Bacanovic, sources say. Stopped from trading by the firm's blackout, Waksal gave instructions to transfer $4.9 million in stock to the account of his younger daughter Aliza Waksal...
...stock was her close friendship with Samuel Waksal, 54, the company's former CEO who was indicted last month on insider-trading charges. Federal prosecutors allege that Waksal learned on Dec. 26 that the U.S. Food and Drug Administration was about to deny approval to ImClone's cancer drug, Erbitux. Between Dec. 26 and Dec. 28, authorities say, Waksal tried to sell $5 million in ImClone stock; brokers at Merrill and Banc of America Securities blocked him. His daughter Aliza, however, sold $2.5 million of ImClone on Dec. 27. And Stewart sold $228,000 worth on the same...
...charges against Waksal stem from his attempt to sell $4.9 million of ImClone stock on Dec. 27. He learned on Dec. 26 that the company's application for the cancer drug Erbitux was going to be denied review by the U.S. Food and Drug Administration--news that the company made public after the markets closed on Dec. 28. He is also accused of tipping off his daughter Aliza, who sold $2.5 million of ImClone, and his father Jack, who sold $6.7 million of the stock ahead of the FDA news. Only Waksal has been charged; he denies wrongdoing...
Ongoing studies described at a recent cancer conference indicate that Erbitux makes chemotherapy more effective. Patients who had not previously responded to chemotherapy benefited when the same chemotherapy drugs were taken with Erbitux. If these results hold up, Erbitux could become a vital part of a multidrug assault on cancer--regardless of ImClone's fate. And Mendelsohn may finally see his vision become a reality. --By Alice Park