Investor Update

Basel, 15 June 2005

FDA approves oral Xeloda for the adjuvant (after surgery) treatment of colon cancer

Colon cancer patients have access to a new effective and more convenient treatment

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Xeloda (capecitabine), an innovative oral chemotherapy, for the adjuvant (post-surgery) treatment of colon cancer patients.

Adjuvant chemotherapy is the standard treatment approach for Dukes’ C colon cancer (Stage III cancer that has spread to the lymph nodes), where chemotherapy is given after the tumour has been surgically removed. This approval will now give patients who have undergone complete resection of their primary tumour the option of an oral chemotherapy when treatment with fluoropyrimidine therapy alone is preferred. Xeloda as an oral fluoropyrimidine compares favourably with intravenous infusion requiring multiple hospital visits.

“Following European approval in March 2005 the FDA also supports Xeloda’s new indication. This again confirms Roche’s commitment to providing innovative solutions for patients, while providing medical resource cost savings for today’s healthcare providers”, said William M. Burns, CEO Division Roche Pharma. “For the first time colon cancer patients will have access to a unique treatment option that provides an effective oral therapy which is well-tolerated and can be taken at home.”

The FDA’s decision was based on the landmark X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial. The trial successfully met its primary endpoint, showing Xeloda is non-inferior to 5-FU/LV for disease-free survival.

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At this time, neither Xeloda nor combination chemotherapy has been shown to prolong overall survival; combination chemotherapy has demonstrated an improvement in disease free survival compared to 5-FU/LV.

On average, a patient only needed 8 hospital visits when treated with Xeloda compared to 30 visits if treated with i.v. 5-FU/LV

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. This results in significant cost savings - an important advantage for doctors, nurses and pharmacists in today’s healthcare environment.

Roche has a large ongoing study programme looking at Xeloda in combination with other chemotherapies and targeted therapies in breast and colon cancer.

“More than 145,000 Americans will be diagnosed with colon cancer this year, so it’s important that the cancer community continually seeks to improve available treatment options,” said Carolyn Aldige, President of the Cancer Research and Prevention Foundation. “We commend Roche’s commitment, as evidenced by today’s FDA approval, to bringing effective and more convenient options to patients with colon cancer.”

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. For further information: www.roche.com

All trademarks used or mentioned in this release are legally protected.

Additional information:
- Presentation of the X-ACT trial, “Capecitabine vs. bolus 5-FU/leucovorin as adjuvant therapy for colon cancer (the X-ACT study): positive efficacy results of a phase III trial”
- Colorectal cancer
- Xeloda in colorectal cancer
- Xeloda
- Roche in oncology
- Broadcast quality B-roll including doctor and patient interviews is available for download via www.thenewsmarket.com

References:
1. Reddy, G. Efficacy of adjuvant capecitabine compared with bolus 5-Fluorouracil/Leucovorin regimen in Dukes C colon cancer: results from the X-ACT trial. Clin Colorectal Cancer, July 2004: 87-88.
2. McKendrick, J.J, Cassidy, J, et al. Capecitabine (x) is resource saving compared with i.v. bolus 5-FU/LV in adjuvant chemotherapy for Dukes’ C colon cancer patients: Medical resource utilization (MRU) data from large phase III trial (X-ACT). Journ of Clin Oncol, 2004 ASCO Annual Meeting Proceedings (Post Meeting Edition). Vol 22, No 14S (July supplement), 2004: 3578

Notes for Editors:

About Xeloda
Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither Xeloda nor combination therapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV.  Physicians should consider these results when prescribing single-agent Xeloda in the adjuvant treatment of Dukes’ C colon cancer. Xeloda is covered by Medicare.

Xeloda Safety Information
A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported.  Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended.  
Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.  Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.  Xeloda can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored.  Patients 80 and older receiving Xeloda monotherapy may experience a greater incidence of grade 3 or 4 adverse events.  Xeloda may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda.  It is recommended that nursing be discontinued when using Xeloda.  Men should use birth control when using Xeloda.

Common adverse events in the adjuvant setting were: diarrhea (Xeloda 47%, 5-FU/LV 65%), nausea (Xeloda 34%, 5-FU/LV 47%), stomatitis (Xeloda 22%, 5-FU/LV 60%), vomiting (Xeloda 15%, 5-FU/LV 21%,), fatigue (Xeloda 16%, 5-FU/LV 16%) and hand-foot syndrome (Xeloda 60%, 5-FU/LV 9%). As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.  Visit http://www.xeloda.com or call Roche at 800-526-6367.