Merck KGaA plans to report results of its pivotal BOND trial of Erbitux (cetuximab) in patients with metastatic colorectal cancer at this year's annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Merck KGaA plans to submit an application for approval of cetuximab to the European Agency for the Evaluation of Medicinal Products and to authorities in Switzerland this summer. If successful, Merck KGaA could bring the cancer drug to market in Switzerland as soon as late 2003 and across the European Union in 2004. Merck licensed the right to market cetuximab outside of the U.S. and Canada and the co-exclusive right to market cetuximab in Japan from ImClone Systems Incorporated of New York in 1998.

Cetuximab, an investigational anti-epidermal growth factor receptor (EGFR) monoclonal antibody, is the most advanced product in Merck KGaA's oncology pipeline and is one of its three key developmental products. The other two key compounds are EMD 72000, a second anti-EGFR monoclonal antibody being studied for the treatment of cervical, ovarian and gastric cancers, and Theratope, a therapeutic vaccine being studied for the treatment of metastatic breast cancer and metastatic colorectal cancer, each of which is the subject of two abstracts at ASCO.

"Bringing cetuximab to market will help establish Merck as a key player in the targeted treatment of cancer," said Prof. Bernhard Scheuble, CEO of Merck KGaA. "It is the first of what we hope will be several drugs designed to selectively target cancer and improve the quality of life for cancer patients."

Financial analysts expect Merck could realize peak annual sales of up to EUR 500 million from cetuximab.