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News Release 30th April 2008

NICE Says ‘Yes’ for Cetuximab (Erbitux) for Treatment of Locally Advanced Head and Neck Cancer

London, 30th April 2008 – The National Institute for Health and Clinical Excellence (NICE) today issued a Final Appraisal Determination (FAD) recommending the use of Erbitux® (cetuximab) in combination with radiotherapy for the treatment of locally advanced head and neck cancer in patients that are contraindicated to all forms of platinum based chemoradiotherapy.1*

This announcement signifies a step forward for patients with head and neck cancer in England and Wales as they will soon have access to this potentially life saving treatment. Once the full guidance has been published, expected on 29th May 2008, it will be fully implemented across the NHS within three months.

Cetuximab is the only targeted therapy to be approved for the treatment of locally advanced head and neck cancer in combination with radiation therapy. Cetuximab is one of the first new treatments in over 40 years that significantly prolongs patient’s survival and control of the disease.2

“The FAD is a positive step as it will ensure NHS access to cetuximab across the UK. Cetuximab has been recommended for use in Scotland since 20063,” said Denise Richard, Head of Oncology Business Unit at Merck Serono.

“As a clinician treating head and neck cancer, I welcome NICE’s decision of offering cetuximab to selected patients who are having radiotherapy as it improves the chance of tumour control without adding to the risk of troublesome radiotherapy-related side effects," said Dr Nicholas Slevin, Consultant in Oncology, Christie Hospital, Manchester.

“The Mouth Cancer Foundation welcomes NICE’s decision. It is something that oncologists and patients alike have been fighting for. It will go a long way to correcting the present post code lottery in head and neck cancer for patients in the UK,” said Dr Vinod Joshi, Founder of the Mouth Cancer Foundation.

More than 7,800 people are diagnosed with head and neck cancer in the UK every year, the majority of which occur in the mouth, pharynx or tongue.4**

Ends

*Cetuximab in combination with radiotherapy is recommended by NICE as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated. Patients currently receiving cetuximab in combination with radiotherapy for the treatment of locally advanced squamous cell cancer of the head and neck, who do not meet the criteria outlined above, should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
The Karnofsky Performance-status index allows patients to be classified as to their functional impairment. A score of 90% or greater means that a patient is able to carry on normal activity or has only minor signs or symptoms.

**Of the people diagnosed with head and neck cancer in the UK every year, 1,400 cases occur in the mouth, 1,650 cases occur in the pharynx and 1,250 cases occur in the tongue

Contacts for further information:

• Rose Lockett, Red Door Communications for Merck Serono UK – Tel. 020 8392 8091 / rlockett@rdcomms.com
• Alistair Martin, Red Door Communications for Merck Serono UK – Tel. 020 8392 8094 / amartin@rdcomms.com

Notes to editors:

The full NICE Final Appraisal Document is available to download from the NICE website at www.nice.org.uk

Cetuximab is a highly active IgG1 monoclonal antibody (mAb) targeted to the Epidermal Growth Factor Receptor (EGFR), and is the only targeted therapy to be approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (LASCCHN) in combination with radiation therapy. It was the first mAb to be licensed for use in colorectal cancer in the EU in June 2004. It is manufactured by Merck Serono.

SMC Guidance

Cetuximab is accepted for restricted use within NHS Scotland in combination with radiation therapy for the treatment of patients with locally advanced squamous cell cancer of the head and neck. It is restricted to patients who are not appropriate for or unable to tolerate chemo-radiotherapy and who are of good performance status with no evidence of distant metastases. It is also restricted to use by specialists in the management of head and neck cancer.

About Merck Serono

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck, was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), metabolic and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®). With an annual R&D investment of € 1bn, we are committed to growing our business in specialist-focused therapeutic areas, such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

For more information, please visit www.merckserono.net or www.merck.de

About Merck KGaA

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.subscribe.merck.de to register online, change your selection or discontinue this service.

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

References

1. Cetuximab for the treatment of locally advanced squamous cell cancer of the head and neck. Final appraisal determination. National Institute for Health and Clinical Excellence. www.nice.org.uk (accessed April 2008)

2. Bonner JA et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006; 354:567-78.

3. SMC press statement on Erbitux for head and neck cancer. www.scottishmedicines.org.uk/ (accessed April 2008)

4. Types of head and neck cancer. Cancerbackup website www.cancerbackup.org.uk/Cancertype/Headneck/General/Typesofh... (accessed April 2008)

Date of preparation: April 2008
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This press release was distributed by ResponseSource Press Release Wire on behalf of Red Door Communications in the following categories: Health, Medical & Pharmaceutical, for more information visit http://pressreleasewire.responsesource.com/about.