Merck Announces Joint Agreement With ImClone And Bristol-Myers Squibb For Erbitux In Japan

Main Category: Pharma Industry / Biotech Industry
Article Date: 18 Oct 2007 - 2:00 PDT

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Merck KGaA announced that it has established an agreement with ImClone Systems Incorporated and Bristol-Myers Squibb Company for the co-development and co-commercialization of Erbitux® (cetuximab) in Japan if approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Under terms of the co-development and co-commercialization agreement, Merck, ImClone Systems and Bristol-Myers Squibb will jointly market the product under the common trademark Erbitux in Japan for the treatment of metastatic colorectal cancer (CRC), as well as for the treatment of any other cancers that the parties decide to pursue. Merck and BMS will utilize their respective sales forces in Japan and the three companies will share development costs, sales and marketing expenses, and profits realized as a result of the agreement. Merck Serono Japan will distribute the product and book the sales for the collaboration.

Pursuant to the Agreement, Merck will receive 50% of the profit or loss from sales in Japan and each of ImClone Systems and BMS will receive 25% of the profit or loss from sales in Japan. In addition to its percentage of profit or loss, ImClone Systems will receive from Merck a royalty equal to 4.75% of total Net Sales in Japan.

Merck, ImClone Systems and Bristol-Myers Squibb submitted an application for the use of Erbitux in treating patients with mCRC to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year. The submission in Japan is a result of a development collaboration between the three companies and was based on results from studies conducted in Europe, North America and Japan. Erbitux is the first monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR) to be submitted for marketing authorization in Japan.

"We are pleased that the plans for development and commercialization of Erbitux in Japan have been confirmed," commented Dr Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono - the division for innovative small molecules and biopharmaceuticals of Merck, Darmstadt, Germany. "This agreement will ensure we can provide Japanese patients with a new important treatment option for metastatic colorectal cancer as soon as our application to the regulatory authorities is approved."

In Japan, the incidence of colorectal cancer has significantly increased over the last 50 years.1 Colorectal cancer is the second most common cancer, after stomach cancer, affecting 95,651 people every year.2 Approximately, 25% of Japanese colorectal cancer patients present with metastatic disease.3 Erbitux was first approved for the treatment of metastatic colorectal cancer in Switzerland in December 2003. It was approved for use in the United States by the FDA in February 2004 and by EMEA in June 2004.

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 69 countries. It has been approved for the treatment of colorectal cancer in 68 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, Malaysia, Mexico, Montenegro, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Serbia, Singapore, 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 61 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Serbia, Singapore, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Nicaragua, Panama, 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 Biomira Inc. of Edmonton, Alberta, Canada.

References:

1. Koyama Y and Kotake K. Dis Colon Rectum. 1997;40:S2-9.
2. http://www-dep.iarc.fr / (Globocan 2002).
3. Cunningham D et al. Eur J Cancer 1993; 29A: 2007-2079.

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 http://www.merckserono.net or http://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 sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,000 employees in 61 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.

http://www.merck.de

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