ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that ImClone Systems has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of Erbitux (cetuximab), in combination with irinotecan, for the treatment of patients with EGFR-expressing irinotecan-refractory metastatic colorectal cancer. Erbitux is an investigational IgG1 monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. The Companies also announced that ImClone Systems has requested priority review of the application and accelerated approval consideration.

"The submission of the Erbitux BLA is a milestone that all of us at ImClone Systems have worked diligently to achieve on behalf of colon cancer patients," stated Daniel S. Lynch, Acting Chief Executive Officer of ImClone Systems. "ImClone Systems with our partners Bristol-Myers Squibb and Merck KGaA worked collaboratively with the FDA towards this submission."

"Erbitux exemplifies our ongoing commitment to bring new oncology medicines to patients in need," said Peter R. Dolan, Chairman and Chief Executive Officer, Bristol-Myers Squibb. "The BLA filing is an important sign of that commitment. Our continued efforts to conduct a range of additional clinical trials with Erbitux to treat colorectal and other cancers speak to our confidence in the future of this compound."