Friday, February 22, 2008

Merck Serono's Erbitux(R) Cited As 'One Of The Most Significant Advances In The Last 25 Years' In The Treatment Of Head And Neck Cancer

Merck Serono, a division of Merck KGaA of Germany, has won a Frost & Sullivan Customer Value Enhancement (CVE) Award for its epidermal growth factor receptor (EGFR) targeted therapy Erbitux®, used in the treatment of head and neck (H&N) cancer. The award - for Merck Serono's efforts to provide "unique products with significant benefits" to clinical specialists and their patients and for its impact on the industry as a whole - comes following Frost & Sullivan's recent analysis of the head and neck cancer therapeutics market.

"Being first in class, Erbitux is perceived to be one of the most significant advancements in the last 25 years in the treatment of head and neck cancer patients," says Frost & Sullivan Programme Leader - Pharmaceuticals and Biotechnology, Paljit Sohal.

"We are very glad that the importance of Erbitux to head and neck cancer patients has been formally recognized by this award. This reflects that Erbitux is an important progress for H&N cancer patients as it combines high efficacy with a favorable safety profile. With these features Erbitux offers the first real improvement in 25 years for the treatment of patients with H&N cancer. Merck Serono is committed to continued research in this type of cancer and others to ensure that as many patients as possible can benefit from Erbitux," commented Dr. Wolfgang Wein, Senior Executive Vice President, Oncology, at Merck Serono. Frost & Sullivan selected Merck Serono for the 2007 CVE award for demonstrating the most value creation compared to other companies in the head and neck cancer area.

Head and neck cancer may occur in the epithelial cells of any tissue or organ in the head and neck region excluding the eyes, brain, ears, thyroid and esophagus. Most head and neck cancers occur in the oral cavity (43%) followed by the pharynx (33%) and the larynx (24%).1 The estimated incidence of head and neck cancers in Europe is around 140,000 annually, with over 65,000 deaths per year.2

Erbitux is approved in 15 countries as a monotherapy in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have failed prior chemotherapy, and in more than 60 countries for the combination with radiotherapy for the treatment of locally advanced SCCHN. Due to its targeted mechanism of action, acting on only epidermal growth factor receptor (EGFR)-expressing tumor cells, Erbitux has a favorable safety profile.

Frost & Sullivan Customer Value Enhancement (CVE) Award
Measurement Criteria

In analyzing companies for CVE recognition, we use specific criteria to determine the final Award rankings. The recipient of this Award has excelled based on one or more of the following criteria:

- Leading proactive initiatives to improve value to customers
- Inclusion of new features and benefits for an existing service or product that enhances value for the client
- Implementation of a new or unique pricing strategy
- Implementation of a new or unique product bundling strategy
- Launch of a new product(s) to offer a "one-stop shop" in response to customer demands
- Launch of a new service protocol to improve overall customer ownership experience
- Launch of a new program to help improve the utilisation rates for products or services procured by clients
- Creating new venues, such as online services, for an established product
- Strategic mergers, acquisitions, or joint ventures to provide additional benefits to the customer

About Frost & Sullivan

Frost & Sullivan, the Growth Consulting Company, partners with clients to accelerate their growth. The company's Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information, visit http://www.awards.frost.com.

About ERBITUX

ERBITUX® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 71 countries. It has been approved for the treatment of colorectal cancer in 70 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 64 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and, upon approval, commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) - an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Bellevue, Washington, USA.

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