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ImClone and Bristol-Myers Squibb Announce Joint Agreement With Merck KGaA to Co-Develop and Co-Commercialize ERBITUX(R) in Japan
Date:10/17/2007

Germany submitted an application in Japan earlier this year for the use of ERBITUX in treating patients with EGFR-expressing mCRC. The submission is a result of a development collaboration among the three companies and is based on results from studies conducted in North America, Europe and Japan. ERBITUX is the first monoclonal antibody that inhibits EGFR to be submitted for marketing authorization in Japan.

"We are pleased to have established this agreement with our ERBITUX partners Bristol-Myers Squibb and Merck KGaA. Doing so puts the companies in a solid position to make ERBITUX available to EGFR-expressing metastatic colorectal cancer patients in Japan upon a final decision from Japanese regulatory officials," said John H. Johnson, Chief Executive Officer of ImClone Systems.

"This agreement further strengthens our partnership with ImClone Systems and Merck KGaA as we focus on maximizing the global potential of ERBITUX," said Lamberto Andreotti, Executive Vice President and Chief Operating Officer, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "If approved in Japan, ERBITUX would be an important new addition to the treatments available to Japanese patients with EGFR-expressing metastatic colorectal cancer."

About Colorectal Cancer

In Japan, the incidence of colorectal cancer has increased markedly during the last 50 years. Among men and women in Japan, the incidence is higher than for lung cancer (95,651 per year vs 66,453) and second to stomach cancer (95,651 per year vs 109,779). In terms of mortality, the ranking is slightly different; colorectal cancer is now the third largest cancer threat in Japan after lung and stomach cancer (38,206, 56,367 and 54,423 people per year, respectively). Approximately 25 percent of colorectal cancer patients present with metastatic disease or cancer that has spread to other organs. EGFR is expressed in 60-80 percent of colorectal cancer tumors.

About ERBITUX(R) (cetuximab)

ERBITUX is a
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SOURCE ImClone Systems Incorporated; Bristol-Myers Squibb Company
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