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Sunday, November 22, 2009 5:08:47 PM
NEW YORK - Today, the former ImClone Systems chief executive, Samuel D. Waksal, was sentenced to 87 months and a $3 million fine for charges of insider trading and fraud related to his attempts to sell stock after learning that U.S. regulators would reject an application for his company's cancer drug, Erbitux. In addition to his prison time, which was the maximum to which he could have been sentenced, Waksal must also make restitution of $1.2 million to the state of New York.
Waksal's fate now appears sealed. But what about cancer patients who have been waiting for Erbitux, not to mention ImClone (otc: IMCLE - news - people ) investors? Earlier this month, new data were presented by ImClone's European partner, Merck KGaA, that seemed to show that the drug might be as effective in colon cancer as was thought before the U.S. Food and Drug Administration rejected ImClone's new drug application. 23% of patients who took Erbitux with chemotherapy saw their tumors shrink--a greater percentage than would be expected with chemotherapy alone.
Those results do look good. Since the data were presented, ImClone shares have rallied by more than a third to $36. But approval is still no sure thing. And while ImClone and U.S. partner Bristol-Myers Squibb (nyse: BMY - news - people ) once seemed to be sitting on a surefire blockbuster, Erbitux's prospects have now dimmed. Avastin, a new drug from Genentech (nyse: DNA - news - people ), increased survival in 50% of colon cancer patients tested when added to chemotherapy. Doctors may try it before turning to Erbitux. Moreover, Amgen (nasdaq: AMGN - news - people ) and Abgenix (nasdaq: ABGX - news - people ) are developing a drug very similar to Erbitux that may boast safety or efficacy advantages--either of which could in turn yield the upper hand in a marketing war.
Pills that work in a similar method to Erbitux also are being tested in colon cancer by AstraZeneca (nyse: AZN - news - people ) and by the team of Genentech and OSI Pharmaceuticals (nasdaq: OSIP - news - people ). That means even if Erbitux is approved--no sure thing--its chances of being a big seller are greatly diminished.
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