Merck Announces Joint Agreement With ImClone and Bristol-Myers Squibb for Erbitux in Japan

Co-development and co-commercialization of Erbitux in metastatic colorectal cancer upon health authority approval

19-Oct-2007

Merck KGaA announced that it has established an agreement with ImClone Systems Incorporated and Bristol-Myers Squibb Company for the co-development and co-commercialization of Erbitux® (cetuximab) in Japan if approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Under terms of the co-development and co-commercialization agreement, Merck, ImClone Systems and Bristol-Myers Squibb will jointly market the product under the common trademark Erbitux in Japan for the treatment of metastatic colorectal cancer (CRC), as well as for the treatment of any other cancers that the parties decide to pursue. Merck and BMS will utilize their respective sales forces in Japan and the three companies will share development costs, sales and marketing expenses, and profits realized as a result of the agreement. Merck Serono Japan will distribute the product and book the sales for the collaboration.

Pursuant to the agreement, Merck will receive 50% of the profit or loss from sales in Japan and ImClone Systems and BMS will each receive 25% of the profit or loss from sales in Japan. In addition to its percentage of profit or loss, ImClone Systems will receive from Merck a royalty equal to 4.75% of total net sales in Japan. Merck, ImClone Systems and Bristol-Myers Squibb submitted an application for the use of Erbitux in treating patients with mCRC to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year. The submission in Japan is a result of a development collaboration between the three companies and was based on results from studies conducted in Europe, North America and Japan. According to the company, Erbitux is the first monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR) to be submitted for marketing authorization in Japan.

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