ImClone Systems Incorporated announced that it has received a $250 million milestone payment under its license agreement with Bristol-Myers Squibb. The cash payment was triggered by U.S. Food and Drug Administration (FDA) approval of Erbitux to treat irinotecan refractory or intolerant metastatic EGFR-expressing colorectal cancer on February 12, 2004.

"This milestone payment represents the acknowledgement by Bristol-Myers Squibb of the progress that we have made together in the Erbitux clinical program, which culminated in the recent approval of the drug in combination with irinotecan and as a single agent in certain patients with late-stage colorectal cancer," stated Daniel S. Lynch, chief executive officer of ImClone Systems. "The Company is dedicated to working closely with its partners Bristol-Myers Squibb and Merck KGaA to conduct additional clinical trials to expand the potential application of Erbitux in colorectal and other EGFR-expressing cancers."

Erbitux is a first-of-its-kind antibody approved for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. Erbitux binds specifically to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.