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Title: Merck KGaA Receives EMEA Positive Opinion for Erbitux in Head and Neck Cancer Recommending Approval in the EU

"Merck KGaA Receives EMEA Positive Opinion for Erbitux in Head and Neck Cancer Recommending Approval in the EU"

DARMSTADT, GERMANY -- February 23, 2006 -- Merck KGaA announced today that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA (European Medicines Agency), for its application to extend the use of Erbitux® (cetuximab) to the treatment of head and neck cancer. With this positive opinion, the CHMP recommends the marketing authorization of Erbitux for this additional indication by the European Commission. Erbitux is currently licensed in the European Union for metastatic colorectal cancer after being first approved in Switzerland in December 2003. Since December 21, 2005, Erbitux has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Switzerland. When approved by the European Commission, Erbitux will be the first targeted cancer therapy for the treatment of head and neck cancer in the EU. The license extension endorses the use of Erbitux as a first-line treatment in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck. "This is encouraging news for patients who present to their physician for the first time with locally advanced head and neck cancer, as 5-year survival rates have traditionally remained poor at around only 33%," said Elmar Schnee, Deputy Member of the Executive Board, Business Sector Pharmaceuticals, Merck KGaA. "This confirms the strong and broad activity as well as combinability of Erbitux. We believe that Erbitux is one of the most significant advances in the treatment of head and neck cancer in the last 30 years. It offers the potential for improved control and prolonged survival in this challenging disease. We are confident that the clear survival benefit demonstrated by Erbitux in head and neck cancer patients reinforces the potential of this medicine in other cancer types." The CHMP decision marks an important milestone in the search for new therapies for head and neck cancer as Erbitux when combined with radiotherapy has shown significant survival improvements and control of locoregional spread of the tumor in patients with this challenging and increasingly prevalent cancer type. Erbitux is an IgG1 monoclonal antibody that blocks the epidermal growth factor receptor (EGFR), which is responsible for tumor growth and spread in various different cancer types and is linked to poor prognosis. By blocking the EGFR, Erbitux works on cancer cells in several ways to inhibit growth, invasion and spread (metastases) of the tumor, repair to cancer cells and angiogenesis (blood supply to the tumor). Erbitux enhances the effects of chemotherapy and radiotherapy. The license application for locally advanced SCCHN is based on the results from an international, phase 3 study of 424 patients, which showed that combining Erbitux with radiotherapy significantly prolonged median survival by 19.7 months (49.0 months vs 29.3 months, respectively) and increased the median time until locoregional failure by 9.5 months compared with radiotherapy alone (24.4 months vs 14.9 months, respectively).[¹ These statistically significant results are based on an analysis from an independent clinical review committee.

Erbitux is also being studied as a first-line treatment for recurrent and/or metastatic SCCHN in combination with platinum-based chemotherapy. In a phase 3 study of 442 patients, Erbitux combined with standard chemotherapy (either cisplatin plus 5-fluorouracil or carboplatin plus 5-fluorouracil) is compared to chemotherapy alone. The primary endpoint is overall survival. Recruitment of this study was recently completed.

Head and neck cancer
In Europe alone, around 100,800 people are diagnosed with head and neck cancer and almost 40,000 die from the disease every year.² Head and neck cancer is the sixth most frequently occurring cancer worldwide.³ Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety⁴ and nearly all express EGFR, which is critical for tumor growth.⁵ Although there have been significant improvements in chemotherapy and surgical techniques, the disease is often particularly challenging to treat since most patients present with advanced disease, have secondary tumors, and suffer from other co-morbidities.⁶

References:
1. Bonner JA et al. Radiotherapy plus Cetuximab for Squamous-Cell Carcinoma of Head and Neck. N Engl J Med. 2006; 354: 567-78
2. www-dep.iarc.fr. April 2002.
3. Hunter KD et al. Profiling early head and neck cancer. Nat Rev Cancer. 2005 Feb; 5 (2): 127-35.
4. Bourhis J and Pinto H. Redefining 'State of the Art' in Head and Neck Cancer. Oral presentation, 6th International Conference on Head and Neck Cancer 7-11 August 2004.
5. Forastiere A, Koch W, Trotti A, Sidransky D, et al. Head and neck cancer. N Engl J Med. 2001;345(26):1890-1900.
6. Lefebvre J-L. Redefining 'State of the Art' in Head and Neck Cancer. Oral presentation, 6th International Conference on Head and Neck Cancer 7-11 August 2004.

SOURCE: Merck

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