Merck KGaA announced that the company is in the process of an internal analysis of its European pivotal clinical trial of cetuximab (Erbitux, C225) in 330 patients with irinotecan-refractory colorectal cancer.

As a result, Merck remains optimistic to meet the regulatory requirements for application and reiterates its commitment to file for approval of cetuximab with the European authorities in the first half of 2003. Subject to regulatory approval, the Europe-wide introduction of cetuximab is scheduled to take place in 2004. In Europe, there are more than 360,000 new cases of colorectal cancer diagnosed each year.

Results of an external analysis of the trial data by an independent radiologic assessment committee (IRAC) are expected to be completed in March 2003. Merck will submit an abstract for presentation of the results of the trial at the annual American Society of Clinical Oncology (ASCO) conference in May 2003.

Cetuximab, an investigational monoclonal antibody, is the most advanced product in Merck KGaA's oncology pipeline. Merck licensed the rights to develop and market cetuximab outside of North America from ImClone Systems Incorporated of New York.