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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 23 February 2007\line \line {\b Oral 
cancer drug Xeloda receives positive opinion from the European Authorities for the treatment of advanced 
gastric cancer} \line Stomach cancer is the second leading cause of cancer-related deaths 
worldwide.{\super 1} \line \line Roche announced today that its 
innovative oral cancer drug Xeloda (capecitabine), in combination with platinum-based chemotherapy, 
has received a positive recommendation from the European Committee for Medicinal Products for Human 
Use (CHMP) for first-line use in patients with advanced gastric (stomach) cancer.\line \line Gastric 
cancer is a particularly serious form of cancer which affects twice as many men as women and occurs 
more frequently in people over age 55.{\super 2}  Annually, there are an estimated 
911,000 deaths worldwide{\super 3}  with nearly 140,000 deaths in Europe alone.{\super 4}  
Xeloda is already licensed in South Korea for the first-line treatment of advanced stomach cancer. \line \line "The 
CHMP opinion is encouraging news for European patients fighting advanced gastric cancer, a particularly 
aggressive and debilitating disease," said Jean-Jacques Garaud, Head of Global Pharma Development 
at Roche. "We look forward to receiving EU approval, another milestone in our commitment to developing 
effective and safe treatments for the millions of cancer patients throughout the world."\line \line The 
positive recommendation is based on results from two phase III studies (ML17032 & REAL 2). The results 
of ML17032 confirmed that patients receiving the Xeloda/cisplatin combination lived at least as long 
without the cancer progressing as those treated with 5-FU/cisplatin. REAL 2, the largest - ever phase 
III study in advanced gastro-oesophageal cancer, demonstrated that Xeloda can replace 5-FU, and that 
patients treated with the combination Xeloda plus oxaliplatin and epirubicin (EOX) lived significantly 
longer, compared to patients treated with standard epirubicin, cisplatin and 5-FU (ECF). \line \line "As 
an oral chemotherapy, Xeloda gives patients a valuable option over the current standard of intravenous 
treatment," said Dr Ian Chau, Gastrointestinal Unit, Department of Medicine, Royal Marsden Hospital, 
Sutton, UK. "Xeloda is as effective as intravenous treatment and reduces the time patients need 
to spend in the hospital, from five days every three weeks to only one day every three weeks, allowing 
patients to lead more routine lives and have more personal time. It may also potentially avoid the need 
of a central intravenous line with its associated inconvenience and complications."\line \line Roche 
is focusing significant research efforts on Xeloda for the treatment of gastrointestinal cancers. It 
is already approved for first-line monotherapy of colorectal cancer that has spread (metastatic) and 
adjuvant (post-surgery) treatment of stage III (Duke\u8217?s stage C) colon cancer.\line \line {\b Study 
ML17032 } \line The study, led by Professor Kang and his team, is a large randomised, 
open-label, international phase III study in advanced stomach cancer.\par}{\pard\f0\li440\ri0\sl360\fs22 - It 
was conducted in 316 patients enrolled in 46 centres across 13 countries in Asia, South America and 
Europe.\par}{\pard\f0\li440\ri0\sl360\fs22 - The study compared the efficacy and safety of Xeloda and 
cisplatin (XP) with intravenous 5-FU and cisplatin (FP): FP is a standard treatment of gastric cancer, 
and is accepted by the majority of regulatory agencies as one of the reference regimens against which 
all other regimens should be compared.\par}{\pard\f0\li440\ri0\sl360\fs22 - The primary end point was 
non-inferiority in progression-free survival.\par}{\pard\f0\li440\ri0\sl360\fs22 - Patients receiving 
the XP combination therapy lived at least as long without the cancer progressing as those treated with 
FP.\par}{\pard\f0\li440\ri0\sl360\fs22 - The study confirms that Xeloda can effectively replace the 
old standard intravenous 5-FU, in combination with cisplatin, as first-line therapy for stomach cancer 
that has spread.\par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 {\b REAL 2 Study} \line The 
largest-ever phase III study in advanced gastro-oesophageal cancer, conducted by Professor David Cunningham 
and his team.\par}{\pard\f0\li440\ri0\sl360\fs22 - It was conducted in 1002 advanced gastro-oesophageal 
cancer patients from 61 centres mainly in the UK.\par}{\pard\f0\li440\ri0\sl360\fs22 - The study aimed 
to establish the potential use of Xeloda (X) and oxaliplatin (O) in untreated patients.\par}{\pard\f0\li440\ri0\sl360\fs22 - Patients 
were randomised to one of four regimens: epirubicin, cisplatin and 5-FU (ECF), epirubicin, oxaliplatin 
and 5-FU (EOF), epirubicin, cisplatin and Xeloda (ECX) or epirubicin, oxaliplatin and Xeloda (EOX).\par}{\pard\f0\li440\ri0\sl360\fs22 - The 
primary comparison was overall survival between the Xeloda and 5-FU containing arms (ECX + EOX versus 
ECF + EOF) and the oxaliplatin and cisplatin containing arms (EOF + EOX versus ECF + ECX). A further 
comparison was survival between all four regimens.\par}{\pard\f0\li440\ri0\sl360\fs22 - The study showed 
that Xeloda was as effective as 5-FU and could replace 5-FU.\par}{\pard\f0\li440\ri0\sl360\fs22 - The 
study showed that patients treated with the combination of Xeloda plus oxaliplatin and epirubicin (EOX) 
live significantly longer, compared to patients treated with standard epirubicin, cisplatin and 5-FU 
(ECF).\par}\line {\pard\f0\li0\ri0\sa360\sl360\fs22 {\b About Xeloda} \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, generally safe, simple and convenient oral chemotherapy in treating 
over 1 million patients to date.\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 Commission and U.S. Food and Drug Administration (FDA) for adjuvant 
(post-surgery) treatment of colon cancer in March and June 2005, respectively.\line Xeloda 
is licensed in combination with Taxotere (docetaxel) in women with locally advanced or metastatic breast 
cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following 
at least intravenous (i.v.) chemotherapy with anthracyclines.\line Xeloda monotherapy is also 
indicated for treatment of patients with locally advanced or metastatic breast cancer that is resistant 
to other chemotherapy drugs such as taxanes and anthracyclines or for whom further anthracycline therapy 
is not indicated.\line In addition to the approval of Xeloda for first-line treatment of stomach 
cancer that has spread in South Korea and the CHMP positive recommendation in Europe, Roche is seeking 
further indications in several countries world-wide.\line The most commonly reported adverse 
events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome.\line \line {\b About 
Roche} \line 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 diseases, 
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 drugs for cancer and transplantation and a 
market leader in virology. 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 people\line in 150 countries 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 Additional 
information:} \line - Gastric and oesophageal cancer fact sheet ( http://www.roche.com/med_mbgastric.pdf) \line - 
Xeloda in gastric cancer fact sheet ( http://www.roche.com/med_mbxeloda.pdf)\line - Roche in oncology ( http://www.roche.com/mboncology-e.pdf)\line - 
Broadcast quality B-roll including doctor, caregiver and patient interviews is available for download 
via www.thenewsmarket.com (http://www.thenewsmarket.com/) \line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 {\b References:} \line 1) 
Ajani, J. Evolving Chemotherapy for Advanced Gastric Cancer. The Oncologist, Oct. 2005; Vol 10, Sup. 
3, 49-582.\line 2) Oncology Channel. www.oncologychannel.com/gastriccancer/. Visited on 15th 
March 2006.\line 3) World Health Organisation, 2005.\line 4) Boyle, P & Ferlay, 
J. Cancer incidence and mortality in Europe 2004. Annals of Oncology 2005; 16(3):481-4883.\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}
}