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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 {\b For non-US media only} \line \line Basel, 
15 June 2005\par}{\pard\f0\li0\ri0\sa360\sl360\fs22 {\b FDA 
approves oral Xeloda for the adjuvant (after surgery) treatment of colon cancer } \line \line Colon 
cancer patients have access to a new effective and more convenient treatment\line \line 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. 
\line \line Adjuvant chemotherapy is the standard treatment approach for Dukes\u8217? 
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.\line \line \u8220?Following European approval 
in March 2005 the FDA also supports Xeloda\u8217?s new indication. This again confirms Roche\u8217?s commitment 
to providing innovative solutions for patients, while providing medical resource cost savings for today\u8217?s 
healthcare providers\u8221?, said William M. Burns, CEO Division Roche Pharma. \u8220?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.\u8221?\line \line The FDA\u8217?s decision was based 
on the landmark X-ACT ({\b X} eloda in {\b A} djuvant {\b C} olon 
Cancer {\b T} herapy) trial. The trial successfully met its primary endpoint, showing 
Xeloda is non-inferior to 5-FU/LV for disease-free survival.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
\line \line 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.\line \line 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{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}} . 
This results in significant cost savings - an important advantage for doctors, nurses and pharmacists 
in today\u8217?s healthcare environment.\line \line Roche has a large ongoing study programme 
looking at Xeloda in combination with other chemotherapies and targeted therapies in breast and colon 
cancer.\line \line \u8220?More than 145,000 Americans will be diagnosed with colon cancer 
this year, so it\u8217?s important that the cancer community continually seeks to improve available treatment 
options,\u8221? said Carolyn Aldige, President of the Cancer Research and Prevention Foundation. \u8220?We commend 
Roche\u8217?s commitment, as evidenced by today\u8217?s FDA approval, to bringing effective and more convenient 
options to patients with colon cancer.\u8221?\line \line {\b About Roche } \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?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\u8217?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 (http://www.roche.com)\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line \line {\b Additional 
information:} \line - Presentation of the X-ACT trial (http://www.asco.org/ac/1,1003,_12-002511-00_18-0026-00_19-009534-00_21-004,00.asp), \u8220?Capecitabine 
vs. bolus 5-FU/leucovorin as adjuvant therapy for colon cancer (the X-ACT study): positive efficacy 
results of a phase III trial\u8221?\line - Colorectal cancer (http://www.roche.com/pages/downloads/company/pdf/mbg180205ce.pdf)\line - 
Xeloda in colorectal cancer (http://www.roche.com/pages/downloads/company/pdf/mbg180205ce.pdf)\line - Xeloda (http://www.roche.com/pages/downloads/company/pdf/mbg180205ce.pdf)\line - 
Roche in oncology (http://www.roche.com/mboncology-e.pdf)\line - Broadcast quality B-roll including doctor and 
patient interviews is available for download via www.thenewsmarket.com (http://roche.synapticdigital.com) \line \line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References: 
\line 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.\line 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\u8217? 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\par}\line \line \line {\b Notes 
for Editors:\line \line About Xeloda} \line Xeloda is indicated as 
a single agent for adjuvant treatment in patients with Dukes\u8217? 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\u8217? C colon cancer. Xeloda 
is covered by Medicare.\line \line {\b Xeloda Safety Information} \line 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 \line 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. \line Age greater than 60 and a diagnosis of cancer 
independently predispose patients to an increased risk of coagulopathy.\line 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.\line 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 www.xeloda.com (http://www.xeloda.com) or call Roche at 800-526-6367.\par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}