Merck KGaA to announce European colorectal cancer study data of Erbitux (Cetuximab) at ASCO

DARMSTADT, Germany, May 27 /CNW/ - Merck KGaA of Darmstadt, Germany, will unveil some of the most eagerly anticipated data at this year's annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Results of its pivotal BOND trial of Erbitux(tm) (cetuximab) in patients with metastatic colorectal cancer will be presented on Sunday, June 1, by Prof. David Cunningham, head of the gastrointestinal and lymphoma units at the Royal Marsden Hospital in London and Surrey, UK, and lead investigator for the BOND study. Prof. Cunningham's presentation is just one of 13 ASCO-accepted abstracts on oncology drugs in the pipeline of Merck KGaA and its U.S. subsidiary, EMD Pharmaceuticals, Inc. Merck KGaA plans to submit an application for approval of cetuximab to the European Agency for the Evaluation of Medicinal Products and to authorities in Switzerland this summer. If successful, Merck KGaA could bring the cancer drug to market in Switzerland as soon as late 2003 and across the European Union in 2004. Merck licensed the right to market cetuximab outside of the U.S. and Canada and the co-exclusive right to market cetuximab in Japan from ImClone Systems Incorporated of New York in 1998. Cetuximab, an investigational anti-epidermal growth factor receptor (EGFR) monoclonal antibody, is the most advanced product in Merck KGaA's oncology pipeline and is one of its three key developmental products. The other two key compounds are EMD 72000, a second anti-EGFR monoclonal antibody being studied for the treatment of cervical, ovarian and gastric cancers, and Theratope, a therapeutic vaccine being studied for the treatment of metastatic breast cancer and metastatic colorectal cancer, each of which is the subject of two abstracts at ASCO. "Bringing cetuximab to market will help establish Merck as a key player in the targeted treatment of cancer," said Prof. Bernhard Scheuble, CEO of Merck KGaA. "It is the first of what we hope will be several drugs designed to selectively target cancer and improve the quality of life for cancer patients." Financial analysts expect Merck could realise peak annual sales of up to EUR 500 million from cetuximab. Oncology Pipeline Like cetuximab, EMD 72000 is an anti-EGFR monoclonal antibody that targets cells that express the epidermal growth factor receptor. It has shown preliminary evidence of anti-tumor activity. EMD Pharmaceuticals, Merck's U.S. affiliate, has started Phase II clinical trials in ovarian cancer and may start enrolling patients in a pivotal Phase III trial by the end of the year. Two abstracts reporting the results of EMD 72000 clinical trials are being presented at ASCO. Two abstracts about Theratope vaccine for the treatment of metastatic breast cancer and metastatic colorectal cancer have also been accepted by ASCO. Final analysis of the pivotal trial of Theratope in 1,030 patients with metastatic breast cancer is expected in June. Merck and EMD Pharmaceuticals licensed the rights to Theratope from Biomira Inc. of Edmonton, Alberta, Canada. Notes to Editors: (*) Merck KGaA will announce Erbitux study results via international newswires on Sunday, June 1, 2003, at 11:30 a.m. Chicago time (6:30 p.m. Frankfurt time). (*) For journalists at the ASCO meeting, Merck KGaA will hold a reception on Sunday, June 1, 2003, at 6:30 p.m. (Chicago time) at the Downtown Hyatt Regency Hotel, Regency Ballrooms C and D. Special press buses from ASCO will leave for the hotel between 6:00 and 6:15 p.m. Please note that official ASCO press identification is required to enter the reception. Featured speakers will be: - Prof. Bernhard Scheuble, CEO of Merck KGaA - Prof. David Cunningham, lead investigator for the BOND study - Prof. Jose Baselga, one of the foremost experts on EGF receptors in cancer Erbitux(tm) is a trademark of ImClone Systems Incorporated of New York. Theratope(r) is a registered trademark of Biomira, Inc. of Edmonton, Canada. About EMD Pharmaceuticals EMD Pharmaceuticals Inc. is a new, fully integrated pharmaceutical company with an initial concentration on launching products in oncology and diabetes. EMD Pharmaceuticals is the U.S. affiliate of Merck KGaA of Darmstadt, Germany. Headquartered in Durham, N.C., EMD Pharmaceuticals focuses on meeting patient and physician needs with innovative pharmaceutical products. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merck.de/subscribe 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.