Breakthough in important new markets

In the battle against colorectal cancer, the form of cancer with the highest number of new cases in the seven largest markets (United States, Japan, Germany, United Kingdom, France, Italy and Spain), Erbitux® (cetuximab) represents an important treatment option. It is also used as a therapy in the treatment of head and neck cancer. Currently, the cancer drug is approved in 68 countries for combination therapy with irinotecan after irinotecan failure in patients with colorectal cancer and in 61 countries in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck. Sales of the Oncology business unit totaled €479 million in 2007. The targeted cancer therapy Erbitux® accounted for a substantial portion of this amount, with sales of the product increasing by 40% to €470 million. Recent launches in key markets such as China, Russia and Brazil led to increasing sales. In addition, the division has meanwhile filed for marketing approval in Japan – the world’s second-largest pharmaceutical market – for the use of Erbitux® in treating patients with advanced colorectal cancer. Every year, more than 38,000 people die from this form of cancer in Japan. Once approval is granted, Merck Serono will co-market the oncology drug in Japan with ImClone Systems Inc. and Bristol-Myers Squibb.

The division is working to further expand the range of approved indications for Erbitux®. For example, an application to extend the use of Erbitux® to include the first-line treatment of metastatic colorectal cancer was submitted to the European Medicines Agency (EMEA) in September 2007.

Sustained growth in the oncology market

According to forecasts by the market research institute IMS Health, the growth of the oncology market will continue. In the next four years, global sales are expected to more than double. Market researchers expect sales to increase from US$ 35 billion in 2006 to around US$ 80 billion in 2011. In the next four years, an estimated 50 new cancer drugs are to be launched. Market researchers expect monoclonal antibodies such as Erbitux® to achieve average annual growth of 14% and sales of US$ 43 billion by 2012. According to Business Insight, business with innovative cancer therapies is the fastest growing segment of the oncology market and at the same time the growth driver of the entire pharmaceutical industry.