ImClone shares plummet
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December 31, 2001: 1:48 p.m. ET
Delay for cancer drug Erbitus sends shares of biotech down sharply.
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NEW YORK (CNN/Money) - Shares of ImClone Systems Inc. fell more than 17 percent Monday after regulators decided not to accept the biotech firm's marketing approval application for cancer drug Erbitux.
ImClone, which is co-developing Erbitux with Bristol-Myers Squibb, said Friday it will meet with the U.S. Food and Drug Administration as quickly as possible to discuss requests for additional information on the drug.
"We will be working closely with the FDA toward the goal of an expeditious acceptance of our [Biologics License Application]," ImClone President and CEO Samuel D. Waksal said.
ImClone is banking on the colorectal cancer drug as a potential blockbuster.
In September, the company signed a co-development and co-promotional agreement with Bristol-Myers in which ImClone would receive $1 billion in three cash payments after reaching certain milestones. ImClone received $200 million upon signing the deal but will not receive a second payment of $300 million until its BLA is accepted.
ABN Amro drug analyst Girish Tyagi said in a research note he now expects the first revenue for Erbitux to come in the second half of 2003, instead of the second half of 2002.
Tyagi said he is assuming sales of $100 million in 2003 and $260 million in 2004.
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