FDA Requests More Information on Erbitux

ImClone Systems Inc. said the Food and Drug Administration asked for more information on its drug Erbitux, a move that may delay approval of the cancer treatment.

ImClone plans to meet with the FDA as soon as possible to discuss what information needs to be provided to regulators. After meeting with regulators, it will be able to assess how long this will delay its application, the company said.

“This drug is critical to them. This is their most important product,” said Matthew Geller, an analyst who follows biotechnology firms for CIBC World Markets.

ImClone shares have fallen 13% since Wednesday on concern that the FDA may request that more data be submitted on Erbitux, a drug for colon, lung and other cancers that it wanted to have on the market in the next six months. ImClone filed for approval of Erbitux on Oct. 31, and the FDA’s deadline for accepting the application was set to expire next week.

The FDA’s request will delay the introduction of the drug by at least a month, said Geller, who has a “strong buy” rating on ImClone shares.

ImClone shares fell $3.05 to close at $55.25on Nasdaq before the announcement was made.