ImClone Systems Announces FDA Approval Of CMC Supplemental BLA For Its BB36 Manufacturing Facility

ImClone Systems Incorporated (NASDAQ: IMCL) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's Chemistry, Manufacturing and Controls (CMC) supplemental Biologics License Application (sBLA) for licensure of its manufacturing facility (referred to as BB36). BB36 is a 30,000 liter capacity, single-product manufacturing facility dedicated to the production of ERBITUX(TM) (Cetuximab). From the beginning of 2002 through the end of 2003, the Company produced approximately 200 kilograms of bulk product which is equivalent to 400,000 doses of ERBITUX. At maximum capacity, BB36 is expected to produce 250 kilograms of bulk product per year.