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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 2 May 2005\line \line {\b Tarceva: 
supplemental 
new drug application filed in the US for treatment of pancreatic cancer} \line \line Roche, 
OSI Pharmaceuticals and Genentech announced today that a supplemental New Drug Application (sNDA) has 
been submitted to the U.S. Food and Drug Administration (FDA) for use of Tarceva (erlotinib) in combination 
with chemotherapy for the first-line treatment of patients with advanced or metastatic pancreatic cancer, 
one of the most difficult to treat cancers.\line \line Tarceva, an oral tablet, 
is the first drug and the only EGFR-targeted treatment shown to prolong survival in a phase III trial 
(PA3) when added to standard of care (gemcitabine) for the treatment of patients with previously untreated 
advanced pancreatic cancer. Tarceva was approved by the FDA in November 2004, and obtained approval 
in Switzerland in March 2005, for the treatment of patients with locally advanced or metastatic non-small 
cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. It has been filed 
for the treatment of advanced NSCLC in the EU for regulatory approval in August 2004.\line \line \u8220?The 
impressive results from the pivotal study that support this submission are very encouraging\u8221? said William 
M. Burns, CEO Division Roche Pharma. \u8220?We are confident that the clear survival benefit demonstrated 
by Tarceva in pancreatic and lung cancer patients reinforces the potential of this medicine in other 
cancer types. We look forward to discussing and filing this data with the EU regulatory authorities.\u8221?\line \line Pancreatic 
cancer is the fourth leading cause of all cancer deaths worldwide{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
and is the tenth most frequently 
occurring cancer in Europe{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}} . 
In 2002, there were more than 78,000 new cases of pancreatic cancer diagnosed 
in Europe.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  Pancreatic cancer is difficult 
to treat, as it is often resistant to chemotherapy and radiotherapy, 
and tends to spread quickly to other parts of the body, leading to its high mortality and short life 
expectancy.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}} \line \line {\b About 
the PA3 study} \line The 
sNDA filing is based on a pivotal phase III multi-center, randomised, double-blind, placebo-controlled 
trial evaluating Tarceva in 569 patients with locally advanced or metastatic pancreatic cancer.\line \line The 
study demonstrated a statistically significant 23.5 percent improvement in overall survival for patients 
receiving Tarceva plus gemcitabine compared to patients receiving gemcitabine plus placebo (hazard ratio 
= 0.81, p-value = 0.025). Twenty-four percent of patients receiving Tarceva plus gemcitabine were alive 
after one year compared to 17 percent of patients receiving gemcitabine plus placebo. So patients taking 
Tarceva improved their chances of being alive after one year from 1 in 5 to 1 in 4. Median survival 
in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo 
arm. An exploratory analysis of survival by pre-treatment characteristics also showed that patients 
with metastatic disease and patients with poor performance status derived a significant survival benefit. 
Progression-free survival in the Tarceva plus gemcitabine arm also was significantly improved (hazard 
ratio = 0.76, p-value = 0.003), although there was virtually no difference in tumour response (9 percent 
in patients receiving Tarceva plus gemcitabine versus 8 percent in the gemcitabine plus placebo arm). 
The full data analysis has been presented at the Second Annual Gastrointestinal Cancers Symposium in 
Hollywood, Fla. in January this year.\line \line The analysis of safety data did 
not reveal any unexpected safety signals beyond that seen in previous studies of Tarceva in both monotherapy 
and combination settings. \line \line {\b About Tarceva} \line Tarceva 
is an 
investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. 
HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation 
and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase 
activity of the HER1 signalling pathway inside the cell. \line \line Tarceva is 
currently being evaluated in an extensive clinical development program by a global alliance among OSI 
Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval for 
the Japanese market. In the United States, Tarceva is jointly marketed by Genentech and OSI Pharmaceuticals.\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. Additional information 
about the Roche Group is available on the Internet (www.roche.com (http://www.roche.com))\line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\line \line \line References:\line 1. 
www.pancreas.org (http://www.pancreas.org)\line 2. www.startoncology.net (http://www.startoncology.net)\line 3. 
Ferlay J et al. GLOBOCAN 
2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0, Lyon; 
IARC Press 2004\line 4. www.cancerhelp.org.uk (http://www.cancerhelp.org.uk)\par}\line \line \line {\b Further 
information} \line - Genentech (http://www.gene.com): www.gene.com\line - OSI 
Pharmaceuticals (http://www.osip.com): www.osip.com\line - 
Cancer (http://www.health-kiosk.ch/start_krebs): www.health-kiosk.ch\line - Roche in oncology (http://www.roche.com/mboncology-e.pdf): 
www.roche.com/pages/\line downloads/company/pdf/mboncology05e_b.pdf\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}
}
