European Approval to Be Sought of Erbitux for Advanced Colorectal Cancer

Merck KGaA said it plans to file shortly for European approval of Erbitux, the drug for advanced colorectal cancer that was rejected by the U.S. Food and Drug Administration in 2001 triggering an insider trading scandal involving partner ImClone Systems Inc.

Prof. David Cunningham, head of the gastrointestinal and lymphoma units at the Royal Marsden Hospital in London, is scheduled to present data from the European trial of Erbitux at the American Society of Clinical Oncology meeting on June 1.

A Merck official said that on the basis of this data, his company plans to submit an application to the European Agency for the Evaluation of Medicinal Products this summer and is hoping to bring the drug to market in Switzerland before the end of this year.

Merck licensed the right to market Erbitux outside of the U.S. and Canada and the co-exclusive right to market it in Japan
from ImClone Systems in 1998.

Other Sources: Merck