ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have established a plan with the U.S. Food and Drug Administration (FDA) for the filing of a supplemental Biologics License Application (sBLA) to seek approval for use of ERBITUX(TM) (Cetuximab) Injection, an IgG1 monoclonal antibody, as a single agent and in combination with radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN). Based on the outcome of discussions with the FDA, the Companies intend to submit an sBLA in the second quarter of 2005 and will request priority review at the time of filing. The FDA has provided written notification that the following clinical trials could form the basis of an sBLA together with other supportive data:
