Colorectal Cancer :: ImClone & Bristol-Myers Squibb with Merck KGaA to develop Erbitux in Japan

ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced that they have established an agreement with Merck KGaA for the co-development and co-commercialization of ERBITUX(R) (cetuximab) in Japan.

Under the terms of the agreement, ImClone Systems, Bristol-Myers Squibb and Merck KGaA will collaborate on a joint effort to develop and, following regulatory approval, market ERBITUX in Japan for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC), as well as for the treatment of any other cancers the parties agree to pursue.

Bristol-Myers Squibb and Merck KGaA will utilize their respective sales forces in Japan, and the three companies will share profits/losses realized as a result of the agreement. Merck Serono Japan will distribute the product and record the sales for the collaboration.

The terms of this new agreement provide that Merck KGaA will receive 50 percent of the profit/loss from sales in Japan, and ImClone Systems and BMS will each receive 25 percent. The sharing of profit/loss reflect the co- exclusive rights to ERBITUX in Japan, previously granted by ImClone Systems to Merck KGaA and Bristol-Myers Squibb. In addition to its percentage of profits, ImClone Systems will receive from Merck KGaA a royalty equal to 4.75 percent of total net sales in Japan.

ImClone Systems, Bristol-Myers Squibb and Merck KGaA of Darmstadt, 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.”

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