Merck KGaA: Erbitux Cancer Drug Approved and Available in Switzerland DARMSTADT, Germany, December 1 /PRNewswire/ -- - Merck KGaA first with innovative, targeted therapy that offers new treatment options and brings new hope to colorectal cancer patients - "This is an important day in the on-going fight against cancer" Merck KGaA announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has approved the use of Erbitux(tm) (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. This is the first approval of Erbitux anywhere in the world. The Swiss authorization allows doctors to administer Erbitux in combination with irinotecan. Swissmedic noted in its correspondence with Merck that the risk-benefit ratio for the combination therapy is favorable. Based on the convincing efficacy and safety data of Erbitux in the treatment of this life threatening disease, Swiss authorities approved Erbitux under an accelerated registration procedure. Upon receiving the Swiss notification, Merck immediately began shipment of the cancer medicine to Switzerland. "We know from inquiries we have been receiving for many months that patients are desperately waiting for Erbitux," said Professor Bernhard Scheuble, CEO of Merck KGaA. "This is an important day in the on-going fight against cancer." Merck submitted applications at the end of June 2003 for approval of Erbitux to both Swissmedic and the European Agency for the Evaluation of Medicinal Products (EMEA). EU marketing authorization is expected in mid-2004. The Swiss approval was based on a large multi-center clinical trial conducted in 11 European countries in 57 hospitals with more than 300 patients diagnosed with advanced metastatic colorectal cancer. In the so- called BOND (Bowel Oncology with Cetuximab Antibody) study, Erbitux, when used in combination with irinotecan chemotherapy, benefited more than half of patients. It shrank tumors in 23% and stopped tumor growth in an additional 33% of these very difficult to treat patients. "Such response rates usually are associated with a prolongation of life ," said Professor David Cunningham, M.D., head of the gastrointestinal and lymphoma units at the Royal Marsden Hospital in London and Surrey, United Kingdom, and lead investigator for the BOND study. Professor Cunningham continued: "Erbitux is likely to change the standard of care for patients with metastatic colorectal cancer as it gives doctors a powerful new tool for patients whose disease is becoming worse despite conventional chemotherapy. With this approval, we enter a new era in how metastatic colorectal cancer is treated." Erbitux is an IgG1 monoclonal antibody that specifically targets and blocks the EGFR (Epidermal Growth Factor Receptor), which is expressed in more than 80% of advanced metastatic colorectal cancers. Erbitux works by blocking the EGF receptor, reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites (metastasis). Blocking the receptor also inhibits the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and inhibits the formation of new blood vessels inside tumors (angiogenesis). This leads to an overall suppression of tumor growth. More than 200,000 Western Europeans develop colorectal cancer each year , with more than half of these already at an advanced stage of the disease at first diagnosis. Merck KGaA licensed the right to market Erbitux outside the U.S. and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems. Note to Journalists: Extensive background information, pictures and illustrations for Erbitux are available at: http://www.media-highlights.merck.de Stock Symbols: Reuters: MRCG Bloomberg: MRK GY Frankfurt Stock Exchange: ISIN: DE 000 659 9905 - WKN: 659 990 All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.subscribe. merck.de to register online, change your selection or discontinue this service. In case of questions, please contact the Media Hotline at: +49 (0) 6151 72 5000. With more than 34,500 employees in 53 countries, the Merck Group generated sales of EUR 7.5 billion in 2002. Founded in 1668 in Darmstadt, Germany, the company aims to be a world leader within its core businesses of pharmaceuticals and chemicals. The Merck Group strongly believes the key to its long-term business success is innovative products created by entrepreneurial and talented employees. Merck groups its operating activities under Merck KGaA, in which the Merck family holds 74% and the remaining 26% is publicly traded. The former U.S. subsidiary, Merck & Co., has been a completely independent company since 1917. DATASOURCE: Merck KGaA Phyllis Carter, Phone +49 (0) 61 51/72-71 44

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