Roche Announces Canadian Regulatory Approval of

Herceptin(R) Basel, Switzerland (PROTEXT) - Revolutionary Treatment Shownto Increase Survival in Advanced Breast Cancer Patients. The Canadian regulatory authorities granted marketing approvalfor Herceptin, Roche's novel treatment for metastatic, oradvanced breast cancer. Herceptin is indicated for the treatmentof metastatic breast cancer patients whose tumours substantiallyoverexpress the HER2 protein. Herceptin is the firstoncoreceptor-targeted treatment which has been shown in clinicaltrials to increase overall survival of patients. Herceptin willbe available to Canadian patients as of today. Herceptin Prolongs Life "Herceptin represents the most significant survival benefit inadvanced breast cancer in over 40 years. This treatment, whencombined with chemotherapy, is the first to offer a survivalbenefit of 24 percent for women whose cancer overexpresses aprotein called HER2 (human epidermal growth factor receptor 2).This type of cancer is very aggressive, extremely difficult totreat and associated with a poor prognosis. However, someHerceptin patients have now survived for five or six years, "said Herceptin study investigator, Dr. Brian Leyland-Jones, Mindade Gunzburg Professor and Chairman, Department of Oncology,McGill University in Montreal. Herceptin's Unique Mechanism of Action Also Results inImproved Side Effect Profile Herceptin works by targeting HER2-overexpressing tumours andblocking the HER2 receptors. This novel mechanism -- targeting aroot cause of metastatic breast cancer -- translates intosignificant clinical benefits. Herceptin, when administered alone, was also found to beeffective and well-tolerated by patients, who experienced almostnone of the commonly observed side-effects associated withchemotherapy such as hair loss, nausea, vomiting and killing ofimmune system cells. Roche Continues Marketing Partnership with Genentech Genentech, the world's leading biotechnology company in whichRoche owns a majority share, has already been marketing Herceptinin the United States since the fall of 1998. Roche has marketingrights for all countries outside the U.S. On 4 February 1999,Roche filed for marketing authorisation in the European Union.Roche is working very closely with regulatory authoritiesworldwide to make this important therapy available to patients assoon as possible. Roche and Genentech continue to work on a joint globaldevelopment programme to explore the clinical efficacy and safetyof Herceptin in other solid tumours that overexpress HER2, suchas non-small cell lung and colorectal cancers. Herceptin complements the existing Roche portfolio of highlyinnovative oncology treatments, such as Xeloda(R) for thetreatment of metastatic breast cancer, MabThera(R) for thetreatment of follicular non-Hodgkin's lymphoma and Roferon-A(R),the first interferon treatment for different forms of cancer. Headquartered in Basel, Switzerland, Roche is one of theworld's leading healthcare groups in the fields ofpharmaceuticals, diagnostics, vitamins and fragrances andflavours. Roche's products and services address all stages ofindividual health maintenance and disease management, includingprevention, diagnosis and treatment, thus enhancing people's wellbeing and quality of life. ots Original Text Service: RochePharmaceuticals Internet: http://www.newsaktuell.de Contact:Kim Callahan, +1-212-453-2425, or Melinda Winter, +1-212-453-2456, both of Fleishman-Hillard, for Roche Pharmaceuticals

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