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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 3 November 2005\line \line {\b Tarceva receives approval 
for pancreatic cancer in the United States} \line \line Tarceva (erlotinib), 
the only EGFR-inhibitor to have shown a survival benefit in lung cancer, will now benefit patients with 
advanced pancreatic cancer following FDA approval in the United States. Pancreatic cancer is one of 
the most aggressive forms of the disease and kills more people within the first year than any other 
cancer. Tarceva is the first new treatment in a decade that has shown a significant improvement in overall 
survival (23%) when added to chemotherapy.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} \line \line Earlier 
in October, Roche submitted a Marketing Authorisation Application to the European health authorities 
for Tarceva to be used in combination with gemcitabine chemotherapy for the first-line treatment of 
patients with advanced pancreatic cancer.\line \line \u8220?Pancreatic cancer is a devastating 
disease, and with Tarceva patients will receive a treatment which offers survival benefits\u8221?, said William 
M. Burns, CEO Division Roche Pharma. \u8220?We are pleased by the decision from the FDA and are committed 
to work with health authorities to make Tarceva available to patients elsewhere.\u8221?\line \line Pancreatic 
cancer is the fifth leading cause of cancer deaths in the developed world{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
and is the tenth most frequently occurring cancer in Europe{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  
with a death rate of approximately 78,000 people per year.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\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.\line \line \u8220?Improvements in therapy in advanced pancreatic cancer have 
been very difficult to come by. As a molecularly targeted agent, erlotinib has been shown to add a survival 
benefit when combined with gemcitabine for patients facing pancreatic cancer,\u8221? said Dr. Malcolm Moore, 
study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada, and Chair of the 
Gastrointestinal Disease Site, NCIC Clinical Trials Group. \u8220?Erlotinib represents a notable step forward 
for patients and healthcare providers in a disease with a very poor prognosis.\u8221?\line \line {\b Phase 
III Studies Show Clear Advantages for Tarceva} \line Both the FDA approval and EU filing 
for Tarceva in pancreatic cancer are based upon the results of the pivotal Phase III randomised study 
(PA3){\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  of 569 patients conducted by the 
National Cancer Institute of Canada Clinical Trials Group based at Queen\u8217?s University. The double blind 
study evaluated Tarceva\u8217?s efficacy in patients with locally advanced or metastatic pancreatic cancer.\line \line The 
results of PA3{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  demonstrated the following: 
\line \u8226? Treatment with Tarceva plus gemcitabine in patients with advanced pancreatic cancer 
resulted in significantly longer survival compared to gemcitabine alone (23%)\line \u8226? 24% of 
patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine 
alone\line \u8226? Patients receiving Tarceva plus gemcitabine experienced significantly longer 
progression-free survival\line \u8226? Tarceva plus gemcitabine was well tolerated by patients with 
no increase in hematological toxicity; Rash and diarrhoea were the principal Tarceva-related side effects 
seen in the study and were generally characterised as mild-to-moderate\line \u8226? Tarceva plus 
gemcitabine reported a safety profile generally consistent with that seen in other studies both monotherapy 
and combination settings\line \line The FDA has approved Tarceva plus gemcitabine 
chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer.\line \line {\b About 
Tarceva } \line Tarceva is a 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 also approved in the US and across the European Union for patients with locally advanced or metastatic 
non small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.\line \line Tarceva 
is currently being evaluated in an extensive clinical development programme by a global alliance among 
OSI Pharmaceuticals, Genentech, and Roche, focussing on earlier stages of NSCLC. Additionally, Tarceva 
is being studied in combination with Avastin in NSCLC. Trials are also being conducted with Tarceva 
in other solid tumours, such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and 
neck and glioma (brain). Chugai is pursuing its development and regulatory approval for the Japanese 
market.\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 \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All trademarks 
used or mentioned in this release are legally protected.\line \line References:\line 1. 
\u160?Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine 
compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the 
National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. (Abstract #1, ASCO 2005. http://bmj.bmjjournals.com/cgi/content/full/322/7296/1240. 
Accessed August 2005.\line 2. \u160?http://www.pancreasfoundation.org/learn/pancreaticcancer.shtml 
Accessed October 2005\line 3. \u160?http://www.startoncology.net Accessed October 2005 \line 4. 
\u160?Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC Cancer 
Base. 
No. 5, Version 2.0, Lyon; IARC Press 2004.\par}\line \line \line {\b Further 
information} \line - Genentech (http://www.gene.com)\line - OSI 
Pharmaceuticals (http://www.osip.com)\line - Cancer (http://www.health-kiosk.ch/start_krebs)\line - Roche 
in Oncology (http://www.roche.com/mboncology-e.pdf)
{\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}
}