--ERBITUX Receives Additional Approval from Health Canada for the First-Line Treatment of Head and Neck Cancer--

ImClone Systems Incorporated (NASDAQ: IMCL) today announced the commercial launch of ERBITUX^® (cetuximab) in Canada for use in the treatment of metastatic colorectal cancer (mCRC). Bristol-Myers Squibb collaborates with ImClone on ERBITUX in North America and is making the product commercially available through its wholly-owned subsidiary Bristol-Myers Squibb Canada.

ERBITUX is approved by Health Canada for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing mCRC who are refractory to other irinotecan-based chemotherapy, and as single agent therapy for patients who are intolerant to irinotecan-based chemotherapy. The trial supporting this approval was conducted by Merck KGaA, Darmstadt, Germany, the partner of ImClone for ERBITUX outside of North America.

“ERBITUX will give us another chance to extend and improve the lives of patients with advanced colorectal cancer for whom irinotecan-based chemotherapy is no longer effective or tolerated,” said Dr. Derek Jonker, oncologist at the Ottawa Cancer Centre. “The availability of another treatment option can have a significant impact on these people’s lives and their families.”

ImClone also announced that Health Canada’s Biologics and Genetic Therapies Directorate has approved ERBITUX for use in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN). ERBITUX represents a new generation of treatment for head and neck cancer and the first new agent approved for this disease in 45 years. In a Phase 3 clinical trial comparing ERBITUX and radiation therapy to radiation alone, patients who received ERBITUX had significantly improved survival (median survival increased from 23 months to 49 months). This trial was conducted by ImClone and Merck KGaA.

“ERBITUX is an important advancement in the treatment of head and neck cancer,” said Dr. Sébastien Hotte, oncologist at the Juravinski Cancer Centre in Hamilton. “The proven clinical benefits achieved with ERBITUX in clinical trials represent an exciting new therapeutic option in patients with head and neck cancer at high risk of recurrence with radiation alone.”

“ImClone is pleased to have ERBITUX available as a new option in treating cancer patients in Canada as we continue our efforts to maximize patient access and fully realize the global potential of ERBITUX,” said Joseph I. DePinto, Vice President, Commercial Operations of ImClone.

About ERBITUX^® (Cetuximab)

ERBITUX (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that ERBITUX inhibits the growth and survival of tumor cells that express the EGFR. No anti-tumor effects of ERBITUX were observed in human tumor xenografts lacking EGFR expression.

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

ERBITUX, in combination with radiation therapy, is indicated for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.

ERBITUX, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

Colorectal Cancer

ERBITUX, as a single agent, is indicated for the treatment of EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent, is also indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan-based regimens.

ERBITUX, in combination with irinotecan, is indicated for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. The effectiveness of ERBITUX in combination with irinotecan is based on objective response rates.