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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 21 September 2005\line \line {\b Tarceva approved in 
Europe for lung cancer} \line \line Thousands of lung cancer patients could 
now live longer and better if they receive a new cancer treatment \u8211? Tarceva \u8211? which was approved today 
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 
(erlotinib) has been shown not only to improve survival by an impressive 42.5% but also to improve disease 
symptoms and quality of life for patients suffering from NSCLC, the most common form of lung cancer. 
Today\u8217?s approval is an important step forward in the fight against this deadly disease \u8211? a disease which 
worldwide claims one life every thirty seconds{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
and currently has very few treatment options. \line \line \u8220?Tarceva takes lung cancer 
treatment a step forward, providing patients, whose treatment options are limited, with not only an 
extended life but one of better quality,\u8221? said William M. Burns, CEO Division Roche Pharma. \u8220?Its approval 
across the EU is a continuation of our commitment to ongoing research in the oncology field, with the 
aim of improving the health and quality of life for people with these devastating diseases.\u8221?\line \line Taken 
as an oral, once-daily therapy, Tarceva is the only EGFR-inhibitor to have demonstrated a survival benefit 
in lung cancer. Currently most lung cancer patients are treated with chemotherapy which can be very 
debilitating due to its toxic nature. Tarceva works differently to chemotherapy by specifically targeting 
tumour cells, so avoiding the unpleasant side-effects of chemotherapy. \line \line \u8220?Despite 
being the biggest cancer killer, lung cancer is an often neglected disease,\u8221? said Dr Giuseppi Giaccone, 
VU Medical Center, Amsterdam. \u8220?Over 50 percent of lung cancer patients in Europe are not receiving second-line 
treatment. With the approval of Tarceva, physicians now have a viable alternative to chemotherapy for 
their patients.\u8221?\line \line {\b Approval Based on Compelling Study Results} \line The 
EU approval was based on a pivotal Phase III study recently published in the {\i New England 
Journal of Medicine}  (NEJM).{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  The 
study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen\u8217?s 
University with the participation of 86 sites from 17 countries around the world. This Phase III study 
(NCIC-CTG BR.21) involved 731 patients with advanced NSCLC whose cancers had progressed after first- 
or second-line chemotherapy. The study compared patients receiving Tarceva monotherapy with placebo.\line \line The 
key study results were:\line \u8226? Treatment with Tarceva in patients with advanced NSCLC resulted 
in significantly longer survival compared to placebo, a 42.5% improvement (6.7 months vs. 4.7 months).\line \u8226? 
31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm.\line \u8226? 
Patients receiving Tarceva had stability or control of their lung cancer-related symptoms such as cough, 
shortness of breath and pain, for significantly longer.\line \u8226? Patients also had a superior 
quality of life and improved physical function compared to those on placebo.\line \u8226? The benefits 
of Tarceva were shown in a broad spectrum of patients.\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 programme 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 marketed by Genentech.\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 protected by law.\par}\line \line \line {\b Additional 
information} \line - Roche in Oncology (http://www.roche.com/mboncology-e.pdf)\line - 
Lung cancer (http://www.lungcancercoalition.org)\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References:\line 1. 
Global Lung Cancer Coalition. Lung cancer facts: Did you know? www.lungcancercoalition.org/cancer_facts.html. 
Accessed 12th September 2005.\line 2. F. Shepherd, J. Rodrigues Pereira, T. Ciuleanu. et al. 
Erlotinib in Previously Treated Non-Small Cell Lung Cancer, A Trial of the National Cancer Institute 
of Canada Clinical Trials Group. N Engl J Med 2005;353:123-32.\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}
}