Merck KGaA Receives Swiss Pre-Notification of Erbitux Marketing Authorization DARMSTADT, Germany, Nov. 13 /PRNewswire-FirstCall/ -- Merck KGaA announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has sent pre-notification of its intent to authorize marketing of Erbitux(TM) (cetuximab) for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. Final approval of Erbitux is expected within 30 days. The cancer treatment should be available to patients in Switzerland upon receipt of final approval. The Swiss authorization should be the first approval for Erbitux in the world and will allow doctors in Switzerland to administer Erbitux in combination with the standard chemotherapy irinotecan. 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). An EU marketing authorization is expected in mid-2004. "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," said Prof. 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 study on which the Swiss are basing their decision. "With this anticipated approval, we enter a new era in how metastatic colorectal cancer is treated." The Swiss application was based on the BOND study, a large multicenter clinical trial conducted in 11 European countries in 57 hospitals with more than 300 patients diagnosed with advanced metastatic colorectal cancer. In the study, Erbitux, when used in combination with irinotecan chemotherapy, showed clinical activity in more than 50% of patients. Erbitux shrank tumors by more than 50% in 23% of patients 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," Cunningham said. "For patients, Erbitux offers new hope, and we are pleased and excited to introduce this much-needed therapy to patients who are suffering from a very aggressive and difficult to treat cancer," said Bernhard Scheuble, CEO of Merck KGaA. "Merck will make every effort to have Erbitux available to patients and oncologists as soon as possible." While Switzerland will be the first country to have Erbitux available to patients there, access for patients in many other countries should be available through the International Pharmacy system. 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 of 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. Erbitux is an IgG1 monoclonal antibody that specifically targets the EGFR (Epidermal Growth Factor Receptor), which is expressed in more than 80% of advanced metastatic colorectal cancers. Erbitux blocks the EGFR, reducing both the invasion of normal tissues by tumor cells, and the spread of tumor to new sites (metastasis). Note to Journalists: Extensive background information and graphics for Erbitux are available at: http://www.media-highlights.merck.de/ 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. 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 CONTACT: Phyllis Carter of Merck KGaA, +49-61-51-72-7144 Web site: http://www.media-highlights.merck.de/ http://www.subscribe.merck.de/

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