Word: erbitux
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...Erbitux, though, promised to wash those troubles away. Last October Sam and Harlan sold stock for $57 million and $54 million, respectively, as part of a deal with Bristol-Myers. But Harlan followed up with a second sale worth $50 million on Dec. 6--just two days after the FDA first privately indicated to ImClone that there might be problems with the Erbitux application. His attorney told the Los Angeles Times that the timing of that sale was "coincidental...
...dispute that Erbitux has great potential, and Sam Waksal's supporters say he deserves the credit. "Erbitux would not have gotten this far, this fast, without Sam," says Icahn, who held ImClone shares last year but sold them months before the FDA rejection. It was in April 1999 that Shannon Kellum, 28 and diagnosed with incurable colon cancer, began taking Erbitux. Within months her tumors had shrunk to a fifth their previous size. Much of the hype around ImClone was built on that one success. ImClone was so eager to cash in that, according to the FDA, it mishandled...
...Erbitux controversy raised questions at last week's congressional hearings on ImClone as to whether FDA protocol encourages insider trading. But agency officials contend that frequent communication with applicants is essential. "If a sponsor chooses to act on that information and insider trade, that's his responsibility," says Robert Temple, director of the FDA's oncology-drug evaluation group. And last week, without naming names, Treasury Secretary Paul O'Neill suggested a solution to the escalating crisis of executives abusing trust. "We ought to hang them from the very highest branches." --With reporting by Andrew Goldstein/Washington and Unmesh Kher...
Twenty years later, Mendelsohn is president of MD Anderson Cancer Center in Houston, and his cancer-fighting approach remains controversial. When his backers at ImClone sought FDA approval for Mendelsohn's Erbitux cancer drug, the agency declined to consider it. By giving cancer patients Erbitux and chemotherapy together in clinical trials, the FDA said, ImClone made it difficult to determine how much impact Erbitux...
Most cancer specialists, though, believe that while Erbitux and the science behind its development are radical, both are solid. Erbitux can home in on a protein beacon found on 80% of tumors, making it a promising candidate for treating a range of cancers, from breast to lung to colon. "Nobody has ever questioned the value or the trustworthiness of the science," says Dr. Larry Norton, head of solid tumor oncology at Memorial Sloan-Kettering Cancer Center in New York City...