BMS, ImClone and Merck KGaA to develop and sell Erbitux in Japan

ImClone Systems and Bristol-Myers Squibb (BMS) have established an agreement with Merck KGaA for the development and commercialisation of Erbitux (cetuximab) in Japan.

Per the agreement, ImClone, BMS 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.

BMS and Merck KGaA will use their respective sales forces in Japan, and the three companies will share profits/losses. Merck Serono Japan will distribute the product and record the sales for the collaboration.

Merck KGaA will receive 50 per cent of the profit/loss from sales in Japan, while ImClone Systems and BMS will each receive 25 per cent. The sharing of profit/loss reflects the co- exclusive rights to Erbitux in Japan, previously granted by ImClone Systems to Merck KGaA and BMS. 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, BMS and Merck KGaA submitted an application in Japan earlier in 2007 for the use of Erbitux in treating patients with EGFR-expressing mCRC. The submission is a result of development collaboration among the three companies and is based on results from studies conducted in North America, the EU and Japan. Erbitux is the first monoclonal antibody that inhibits EGFR to be submitted for marketing authorisation in Japan.

John H Johnson, ImClone's CEO, said: "We are pleased to have established this agreement with our Erbitux partners BMS 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."

Lamberto Andreotti, executive vice-president and COO of worldwide pharmaceuticals at BMS, said: "This agreement further strengthens our partnership with ImClone Systems and Merck KGaA as we focus on maximizing the global potential of Erbitux. If approved in Japan, Erbitux would be an important new addition to the treatments available to Japanese patients with EGFR-expressing metastatic colorectal cancer."