Monday, Mar 2, 1998
South San Francisco, Calif. and Glostrup, Denmark -- March 2, 1998 --Genentech, Inc. (NYSE: GNE) and DAKO A/S today announced an agreement under which DAKO will develop an in vitro diagnostic kit to be used to screen breast cancer patients for overexpression of a growth factor receptor known as HER2 and potential eligibility for treatment with Genentech's humanized monoclonal antibody to HER2, Herceptin (Trastuzumab), which is currently under development.
"We are pleased to announce our collaboration with DAKO in potentially bringing a highly specific HER2 overexpression detection kit to the market in conjunction with Herceptin, our investigational treatment for HER2 overexpressing metastatic breast cancer," said Susan Hellmann, MD, MPH, Genentech senior vice president of Development and Chief Medical Officer. "Our efforts will help provide physicians with a reliable diagnostic tool to identify patients with this aggressive form of breast cancer who may be eligible for treatment with Herceptin."
"Our cooperative development with Genentech of the HER2 antibody-based test is a major landmark in our efforts to bring the expertise of DAKO in cancer diagnostics to the marketplace to the benefit of breast cancer patients," said Sven Erik Godtfredsen, DAKO vice president of Corporate Research and Development. "We are hopeful that our product will contribute significantly to accurate diagnosis and optimal treatment of patients suffering from this serious disease."
Under the terms of the agreement, Genentech will grant to DAKO a license under Genentech patent rights and know-how for development of an immunohistochemical (IHC) kit that will potentially be used to diagnose overexpression of HER2 in breast cancer patients. In exchange, DAKO will pay Genentech a royalty on the worldwide sales of DAKO's IHC detection kits.
Studies show that 25 to 30 percent of all women with breast cancer overexpress HER2, or produce excessive amounts of the HER2 growth factor receptor, on the surface of breast cancer cells. Data from epidemiological studies suggest that the disease in these women is especially aggressive, metastasizing, or spreading, to other parts of the body at a faster rate than in breast cancer patients who do not overexpress HER2.
In December, Genentech announced favorable preliminary results of its Phase III clinical trials of Herceptin in HER2 overexpressing metastatic breast cancer. Genentech and DAKO intend to file regulatory applications with the U.S. Food and Drug Administration for Herceptin and the HER2 IHC detection kit in the second quarter of this year with the hope of simultaneous commercial introductions of the products in the United States.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science. Genentech markets or promotes eight biotechnology products in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange and Pacific Exchange under the symbol GNE.
DAKO develops, manufactures and sells diagnostic products for histochemistry, flow cytometry, clinical immunochemistry and microbiology. The majority of DAKO products are derived from the company's own research and expertise in antibody and probe technologies. The company has headquarters in Copenhagen, Denmark and subsidiaries in the United States, Japan and all major European countries.
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