Press Release

• Erbitux approved for 1st-line use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in Europe
• Approval based on the results of the EXTREME study, which showed first significant overall survival benefit in this setting in 30 years

Darmstadt, December 1, 2008 – Merck Serono, a division of Merck KGaA, announced today that it has received approval from the European Commission to extend the use of its targeted therapy Erbitux® (cetuximab) to include 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease.

The approval is based primarily upon the results of the EXTREMEa study, published in the New England Journal of Medicine in September 2008. The EXTREME study established that adding Erbitux to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.1

Patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:1

· Median overall survival increase of nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (HR: 0.80) during the study period

· 70% increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)

· 80% relative increase in response rate (36% vs. 20%; p<0.001)

“To receive approval for Erbitux in the 1st-line treatment of recurrent and/or metastatic SCCHN is fantastic news. We hope that patients and specialists are equally encouraged by this first significant advance in this treatment setting in 30 years,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “This latest approval recognizes the impressive potential of Erbitux to extend patients' lives and further confirms the high activity of Erbitux against difficult to treat cancers.”

In Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease, each year.2 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.3 Head and neck cancer is the sixth most common cancer worldwide4 and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinuses, and other sites located in the head and neck area. Erbitux targets the epidermal growth factor receptor (EGFR). About 90% of head and neck cancers are of the squamous cell variety5 and nearly all express the, EGFR which is critical for tumor growth.6

a EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer

References
1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. GLOBOCAN 2002 (www-dep.iarc.fr), accessed November 2008.
3. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
4. Hunter KD, et al. Nat Rev Cancer 2005;5(2):127-35.
5. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
6. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.

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