Roche

US Gastroenterology & Hepatology Review, 2005:1-1

About Roche
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups, with core businesses in pharmaceuticals and diagnostics. It is the leading supplier of pharmaceuticals for cancer and one of the world’s leaders in diagnostics, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis, and treatment of disease, Roche contributes on many fronts to improve people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the US.

Roche’s US operations celebrate their American Centennial in 2005. In another milestone this year,Roche was named in January in Fortune Magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen US sites, and has alliances and research and development (R&D) agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, please visit Roche’s worldwide and US websites (Global: www.roche.com and US:www.roche.us).

About Xeloda
Xeloda is the first oral enzymatically-activated chemotherapy drug that works through conversion to the cancer-fighting substance fluorouracil (5-FU). Xeloda belongs to a class of drugs called fluoropyrimidines.

Xeloda in pill form is inactive when first swallowed and, therefore, harmless to the body. This non-toxic compound travels through the digestive system into the bloodstream and is carried throughout the body. When it finally comes in contact with a naturally occurring protein called thymidine phosphorylase (TP), Xeloda is transformed into 5-FU, a powerfully cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than normal tissue does, more 5-FU is delivered to the tumor rather than to other tissue. Conversely, intravenous 5-FU is cytotoxic immediately upon entering the body, to both healthy and tumor tissue.

Xeloda is currently indicated as first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared with 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

Xeloda® (capecitabine) in combination with Taxotere® (docetaxel) is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracyline-containing chemotherapy.

Xeloda monotherapy is indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g. patients who have received cumulative doses of 400mg/m2 of doxorubicin or doxorubicin equivalents.