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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 20 September 2004\line \line {\b Significant 
Survival Benefit for Breakthrough Drug Tarceva in Advanced Pancreatic Cancer} \line Study 
shows a significant improvement in overall survival for patients given Tarceva combined with chemotherapy 
versus chemotherapy alone\line \line Roche, Genentech, Inc. and OSI Pharmaceuticals, 
Inc., today announced positive results from a phase III study of investigational drug Tarceva (erlotinib) 
in locally advanced or metastatic pancreatic cancer patients. The study met its primary endpoint of 
improving overall survival.\line \line This study demonstrated a statistically significant 
23.5 percent improvement in overall survival for patients with locally advanced or metastatic pancreatic 
cancer receiving Tarceva plus gemcitabine, when compared to patients receiving gemcitabine alone (a 
hazard ratio of 0.81 and a p-value of 0.025 were observed). A statistically significant improvement 
in progression-free survival was also demonstrated although no differences in tumour response were observed.\line \line Pancreatic 
cancer is the fourth leading cause of all cancer deaths; in Europe each year 60,000 people are diagnosed 
with pancreatic cancer and current treatment options are limited.\line \line \u8220?The 
survival benefit delivered in this study is particularly exciting, as these results come on top of the 
good data in lung cancer. This means new hope for pancreatic patients who currently have a poor prognosis 
and further encourages us that Tarceva may have significant potential in a number of cancers,\u8221? said 
William M. Burns, Head of Roche\u8217?s Pharmaceuticals Division. \u8220?This study reaffirms Tarceva\u8217?s position 
as the fifth product in our oncology portfolio with a proven survival benefit alongside Herceptin, MabThera, 
Xeloda and Avastin, underlining Roche\u8217?s leadership in oncology.\u8221?\line \line \u8220?The 
results of this trial of Tarceva in combination with gemcitabine represent an important advancement 
in treating patients with pancreatic cancer,\u8221? stated Dr. Malcolm Moore, Study Chair and Medical Oncologist 
at Princess Margaret Hospital and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. 
\u8220?Pancreatic cancer is widely recognized as a difficult disease to treat and new therapeutic regimens 
are desperately needed. These results also demonstrate that the HER1/EGFR signalling pathway is an important 
target in pancreatic cancer, and offer hope that further progress can be made.\u8221?\line \line In 
a recent study, Tarceva was shown to significantly improve survival in non-small cell lung cancer (NSCLC), 
the most common type of cancer worldwide. A Marketing Authorisation Application for Tarceva monotherapy 
treatment of advanced non-small cell lung cancer was recently made to the European health authorities 
and to the US Food and Drug Administration (FDA). Early-stage trials of Tarceva are also being conducted 
in other solid tumours, such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and 
gastrointestinal cancers.\line \line {\b About the Study} \line The 
multi-centre, randomised, double-blind, placebo-controlled Phase III international study was conducted 
by the National Cancer Institute of Canada, Clinical Trials Group at Queens University (NCIC CTG) in 
collaboration with OSI Pharmaceuticals. The study evaluated Tarceva at 100mg/day or 150mg/day in patients 
with locally advanced or metastatic pancreatic cancer. Patients received either gemcitabine with Tarceva 
or gemcitabine plus placebo. A total of 569 patients were randomised into the study, with 521 patients 
receiving 100mg/day Tarceva or placebo and 48 patients receiving 150mg/day Tarceva or placebo. The study 
was an international study with sites in the U.S., Asia, Canada, Europe, Australia and South America.\line \line This 
international study demonstrated a statistically significant 23.5 percent improvement in overall survival 
for patients with locally advanced or metastatic pancreatic cancer when compared with overall survival 
in patients receiving gemcitabine plus placebo. A hazard ratio of 0.81 and a p-value of 0.025 were observed 
(a hazard ratio of less than one indicates a reduction in the risk of death and a p-value of less than 
0.05 indicates statistical significance). A statistically significant improvement in progression-free 
survival was also demonstrated although no differences in tumour response were observed. A preliminary 
analysis of the safety data did not reveal any unexpected safety signal beyond that seen in prior experience 
of Tarceva use in both monotherapy and combination settings.\line \line {\b About 
Tarceva} \line Tarceva is a small molecule designed to target the human epidermal growth 
factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in many cancers. 
HER1, also known as EGFR, is a key component of the HER signalling pathway, which plays a role in the 
formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity 
of the HER1 signalling pathway inside the cell, which may block tumour cell growth. Previous studies 
have shown that Tarceva is the first agent to show a survival benefit in patients with relapsed non-small 
cell lung cancer, resulting in Roche\u8217?s recent submission of a Marketing Authorisation Application to 
the European health authorities for Tarceva for the monotherapy treatment of advanced non-small cell 
lung cancer. A similar application for Tarceva has also been made to the U.S. Food and Drug Administration.\line \line {\b About 
Pancreatic Cancer} \line The pancreas is a large organ lying behind the stomach that is 
essential in the metabolism of sugar and fat. Cancer of the pancreas strikes about 5 out of every 100,000 
people and is one of the deadliest forms of cancer. Approximately 60,000 new cases of pancreatic cancer 
are diagnosed per year in Europe and 30,000 new cases in the US. The prognosis is poor for pancreatic 
cancer patients, with most studies showing 5-year survival of less than 5%. Those at the highest risk 
are in their 60s to 80s. Most pancreatic tumours originate in the cells of the pancreas that produce 
digestive enzymes (acinar cells). These adenocarcinomas account for almost 95% of pancreatic tumours.\line \line {\b About 
Roche in Oncology} \line Within the last five years the Roche Group including its partners 
Genentech in the US and Chugai in Japan has become the world\u8217?s leading provider of anti-cancer treatments, 
supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed 
products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced 
stage breast cancer, MabThera in non-Hodgkin\u8217?s lymphoma, and Avastin in colorectal carcinoma. In the 
United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with 
Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible 
for the marketing of these drugs.\line \line The Roche oncology portfolio also includes 
NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast 
cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced 
nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant 
melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia 
management. The Roche Group\u8217?s cancer medicines generated sales of more than 3.3 billion Swiss francs 
in the first half of 2004.\line \line Roche is developing new tests, which will 
have a significant impact on disease management for cancer patients in the future. With a broad portfolio 
of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, 
as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer 
focused treatments and diagnostics.\line \line Roche Oncology has four research 
sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and 
Switzerland).\line \line {\b About Roche} \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?s leading innovation-driven healthcare groups. Its 
core businesses are pharmaceuticals and diagnostics. As a supplier of products and services for the 
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 number one in the global diagnostics market, 
the leading supplier of pharmaceuticals for cancer and transplantation and a market leader in virology. 
In 2003 prescription drug sales by the Pharmaceuticals Division totalled 19.8 billion Swiss francs, 
while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 
people in 150 countries and has alliances and R&D agreements with numerous partners, including majority 
ownership interests in Genentech and Chugai.\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All trademarks 
used or mentioned in this release are legally protected.\par}\line \line {\b Further 
Information:} \line - Genentech (http://www.gene.com): www.gene.com\line - OSI 
Pharmaceuticals (http://www.osip.com): www.osip.com\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}
}
