ImClone Systems To File sBLA For Use Of Erbitux In Head And Neck Cancer In Third Quarter 2005

NEW YORK--(BUSINESS WIRE)--June 20, 2005--ImClone Systems Incorporated (NASDAQ: IMCL) announced today that, following discussions with the FDA, the Company intends to submit a supplemental Biologics License Application (sBLA) to seek approval for use of Erbitux(R) (Cetuximab) in combination with radiation and as a single agent in Squamous Cell Carcinoma of the Head and Neck (SCCHN) in the third quarter of 2005. The following clinical trials would serve as the basis of the sBLA, together with other supportive data: -- A randomized, international phase III trial (IMCL-9815), conducted by ImClone Systems and Merck KGaA, presented at the 2004 American Society of Clinical Oncology (ASCO) annual meeting examining the impact of combining Erbitux with radiation on locoregional control and overall survival in 424 patients with locally advanced SCCHN. and -- A multicenter phase II trial (EMR-016) conducted by Merck KGaA presented at the 2004 ASCO annual meeting evaluating the response rate of Erbitux as a single agent in 103 patients with advanced recurrent and/or metastatic SCCHN not suitable for further local therapy and who have failed platinum-based chemotherapy.