Merck KGaA says that marketing authorisation has been granted in Japan for the use of Erbitux as a treatment for patients suffering from colorectal cancer.

Specifically, the country’s Ministry of Health, Labor and Welfare says that Erbitux (cetuximab) can be used to treat patients with epidermal growth factor receptor-positive, curatively inoperable, advanced or recurrent colorectal cancer. The label also allows the use of Erbitux plus irinotecan in second- and further lines of metastatic colorectal cancer.

The drug was submitted to the MHLW in January 2007 and the filing was based on six different trials, including two studies conducted in Japanese patients. Merck noted that in Japan, the incidence of CRC has increased markedly during the last 50 years with currently around 95,651 cases every year. It has become the most common cancer among women and the second most common among men, after stomach cancer.

Last October, Merck extended its relationship with US partners ImClone Systems (which discovered the drug) and Bristol-Myers Squibb by signing a marketing deal for Erbitux in Japan. Initially, B-MS and Merck will use their respective sales forces to shift the product and the latter’s Merck Serono Japan unit will distribute it.

Under the financial terms of the agreement, Merck will receive 50% of the profits from sales in Japan, and ImClone and B-MS will each receive 25%. In addition to this, ImClone will get a royalty from the German-headquartered firm equal to 4.75% of total net sales in Japan.