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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 19 November 2004\line \line {\b US 
approval for breakthrough lung cancer medicine Tarceva } \line Targeted treatment significantly 
improves survival of patients with advanced lung cancer\line \line Roche, OSI Pharmaceuticals 
and Genentech announced today that the US Food and Drug Administration (FDA) have approved Tarceva (erlotinib) 
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 in the United States. Tarceva is the first 
and only EGFR-targeted treatment to have shown a significant survival benefit in patients with NSCLC, 
improving survival by 42%.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  EGFR is a 
key component of the human epidermal growth factor receptor pathway, which plays a role in the formation 
and growth of numerous cancers.\line \line Lung cancer is the 
most 
common cancer worldwide{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  with 1.2 million 
new cases annually; NSCLC accounts for almost 80 percent of all these cases. Lung cancer has a particularly 
high morbidity and every 30 seconds{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  someone 
in the world dies of the disease. With very limited treatment options available, the FDA approval of 
Tarceva provides patients, with advanced disease, access to this much needed, novel anti-cancer drug. 
\line \line Tarceva is also currently under review for marketing authorisation with 
the European and other health authorities. \line \line "Tarceva is the first 
treatment of its kind to have shown an impressive survival benefit in patients with advanced cancers,\u8221? 
said William M. Burns, Head of Roche Pharmaceuticals Division. \u8220?The speed of which the FDA has approved 
Tarceva is testimony to this. We are pleased that patients in the US will now be able to benefit from 
this innovative treatment and we are working closely with European and other regulatory authorities 
to bring this treatment to other patients as quickly as possible\u8221?\line \line The 
FDA approval was based on results from the pivotal Phase III randomised trial (BR.21) involving 731 
patients, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following 
failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly longer 
than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42%.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
There was also a significant increase in both the length of time before patients symptoms deteriorated 
and the time when patients were stable, and there was no progression of their cancer. In addition, there 
was a 45% improvement in survival at one year and further analysis showed treatment benefit over 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 Similarly 
to the significant survival benefit in NSCLC, Tarceva has also shown survival benefit in a phase III 
study in locally advanced or metastatic pancreatic cancer patients. The study met its primary endpoint 
of improving overall survival. \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. \line \line {\b Roche 
in Oncology } \line Within the last five years the Roche Group including its members 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 five products with survival 
benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, 
MabThera in non-Hodgkin\u8217?s lymphoma, Avastin in colorectal carcinoma and Tarceva in non-small cell lung 
cancer.\line In the United States Herceptin, MabThera and Avastin are marketed either by Genentech 
alone or together with Biogen Idec Inc. (MabThera). Outside of the United States, Roche and its Japanese 
partner Chugai are responsible for the marketing of these medicines.\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 5.6 billion Swiss francs in the first nine months 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 research-intensive healthcare groups. Its 
core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 medicines for cancer and transplantation and a market leader in virology. In 
2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while 
the Diagnostics Division posted sales of 7.4 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.\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 {\b Reference} :\line 1. 
Shepherd, F.; A randomized placebo-controlled trial of erlotinib in patients with advanced non-small 
cell lung cancer (NSCLC) following failure of 1st line or or 2nd line chemotherapy. A National Cancer 
Institute of Canada Clinical Trials Group (NCIC). (Abstract #7022), ASCO 2004. \line 2. World 
Health Organisation, World Cancer Report, 2003. \line 3. www.lungcancercoalition.org/cancer_facts.html.\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\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}
}