ImClone and Bristol-Myers Squibb have established an agreement with Merck KgA to co-develop and co-commercialize Erbitux in Japan. The three companies will collaborate on a joint effort to develop and, following regulatory approval, market the drug 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 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.

Merck will receive 50% 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 to the other two companies. In addition to its percentage of profits, ImClone will receive from a royalty from Merck of approximately 4.75% of total net sales in Japan.

The companies submitted an application in Japan earlier, based on results from studies conducted in North America, Europe and Japan. Erbitux is the first EGFR-inhibiting MAb to be submitted for marketing authorization in Japan.

“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, BMS. “If approved in Japan, Erbitux would be an important new addition to the treatments available to Japanese patients with EGFR-expressing metastatic colorectal cancer.”