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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 27. March 2007\line \line {\b Roche 
submits application to the FDA for use of XELOX (Xeloda plus oxaliplatin) with or without Avastin for 
the treatment of advanced colorectal cancer} \line Submission based on results from trials 
showing XELOX is as effective as standard of care in terms of progression-free survival \line \line \line Roche 
announced today the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug 
Administration (FDA) for the use of Xeloda (capecitabine) in combination with oxaliplatin \u8211? XELOX \u8211? 
with or without Avastin (bevacizumab) in the treatment of metastatic colorectal cancer.\line \line "This 
filing marks a significant milestone for Xeloda, which continues to demonstrate its value as a cornerstone 
in combination therapies, as in this case with oxaliplatin and Avastin. It further supports Roche\u8217?s 
longstanding commitment to advancing treatment for patients with colorectal cancer," said Jean-Jacques 
Garaud, Roche\u8217?s Global Head Pharma Development.\line \line The submission to the 
FDA is based on results from two large, international, Phase III studies (NO16966 and NO16967) which 
showed XELOX to be as effective - in terms of progression-free survival (PFS) - as the current standard 
treatment, FOLFOX- 4 (intravenous bolus and infusional 5-fluorouracil plus oxaliplatin). Study NO16966 
also showed that XELOX in combination with Avastin significantly improved progression-free survival 
over XELOX alone.\line \line In Europe, Roche will be applying for a label extension 
for Xeloda use in combinations, including with oxaliplatin (XELOX) and Avastin, for the treatment of 
metastatic (advanced) colorectal cancer. Similarly, the label extension for Avastin broadens the use 
of the treatment to include combination with fluoropyrimidine- based chemotherapy in patients with metastatic 
cancer of the colon or rectum. \line \line Colorectal cancer accounts for 13 percent 
of all cancers in Europe.{\super 1} \line \line Avastin was first 
approved, in Europe, in January 2005 for first-line treatment of patients with advanced colorectal cancer 
in combination with chemotherapy regimens of intravenous \line 5-fluorouracil (i.v. 5-FU)/folinic 
acid or i.v. 5FU/folinic acid/irinotecan. Xeloda is currently indicated as monotherapy for first-line 
treatment of patients with advanced colorectal cancer. Xeloda is also indicated as post-surgery treatment 
for colon cancer. \line \line {\b About the Studies} \line \line {\b NO16966} \line NO16966 
is a large, international Phase III trial which finally recruited 2,034 patients. It was originally 
planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer.\line \line After 
release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate 
using a 2 by 2 factorial design:\par}{\pard\f0\li440\ri0\sl360\fs22 - FOLFOX/XELOX + placebo 
vs FOLFOX/XELOX + Avastin\par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 The primary objective was 
to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition 
of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary 
endpoints included overall survival, overall response rates, time to, and duration of, response and 
safety profile. \line \line Results of the study showed:\par}{\pard\f0\li440\ri0\sl360\fs22 - The 
chemotherapy combination XELOX is as effective in terms of progression-free survival- a measure of the 
time patients live without their disease progressing - as FOLFOX;\par}{\pard\f0\li440\ri0\sl360\fs22 - The 
addition of Avastin to chemotherapy (FOLFOX and XELOX) significantly improved progression-free survival 
compared to chemotherapy alone. \par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 {\b NO16967} \line The 
NO16967 trial is a large, international phase III trial which randomized 627 patients from 15 countries 
world-wide who had previously received chemotherapy and whose disease had returned or continued to progress. 
\line The primary objective was to answer whether the XELOX regimen (Xeloda plus oxaliplatin) 
is as effective as FOLFOX-4 (i.v. bolus and infusional 5-FU/leucovorin plus oxaliplatin) in terms of 
progression free-survival. The secondary outcomes to be reviewed included overall survival, overall 
response rates, and safety profile.\line \line The results showed:\par}{\pard\f0\li440\ri0\sl360\fs22 - The 
chemotherapy combination XELOX is as effective in delaying disease progression as the chemotherapy combination 
FOLFOX. \par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 {\b About Xeloda (capecitabine)} \line Xeloda 
is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and 
has been shown to be an effective, safe, simple and convenient oral chemotherapy in treating over 1 
million patients to date.\line \line Roche received marketing authorisation for 
Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal 
cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. 
Xeloda has also been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration 
(FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.\line \line Xeloda 
is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast 
cancer that has spread to other parts of the body) and whose disease has progressed following i.v. chemotherapy 
with anthracyclines. \line \line Xeloda monotherapy is also indicated for treatment 
of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel 
and anthracyclines. Xeloda recently received approval in South Korea for the first-line treatment of 
patients with locally advanced (metastatic) pancreatic cancer, in combination with gemcitabine. Xeloda 
is licensed in South Korea for the first-line treatment of stomach cancer. \line \line The 
most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis 
and hand-foot syndrome (palmar-plantar erythrodysesthaesia).\line \line {\b About 
Avastin (bevacizumab)} \line Avastin is the first treatment that inhibits angiogenesis 
- the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin 
targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator 
of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and 
its spread throughout the body (metastasis).\line \line In the US, Avastin was approved 
in February 2004 and in Europe in January 2005 for first-line treatment of patients with metastatic 
colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for 
patients with advanced colorectal cancer. Following priority review, Avastin was approved by the FDA 
in October 2006 for the treatment of non-small cell lung cancer (NSCLC); a filing for the same indication 
was submitted to EU authorities in August 2006. Most recently (in February 2007), a positive recommendation 
was received by the CHMP for the use of Avastin in first line treatment of metastatic breast cancer 
and a positive recommendation was received in Japan for the use of Avastin in patients with advanced 
or recurrent colorectal cancer.\line \line Roche and Genentech are pursuing a comprehensive 
clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, 
lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced 
and adjuvant ie post-operation). The total development programme is expected to include over 40,000 
patients worldwide.\line \line For more information, please visit www.avastin-info.com (http://www.avastin-info.com)\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 the world\u8217?s 
biggest biotech company and an innovator of products and services for the early detection, prevention, 
diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people\u8217?s 
health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, 
a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, 
inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 
33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche 
employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, 
including majority ownership interests in Genentech and Chugai. Additional information about the Roche 
Group is available on the Internet at 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 protected by law.\par}\line \line \line {\b Further 
Information } \line - Roche in oncology (http://www.roche.com/pages/downloads/company/pdf/mboncology05e_a.pdf)\line - Roche: www.roche.com (http://www.roche.com) 
\line Broadcast quality B-roll including doctor, caregiver and patient interviews is available 
for download via www.thenewsmarket.com (http://roche.synapticdigital.com) \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 \line {\b References:} \line 1) 
Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005;16:481-488\par}\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}
}