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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 26 August 2004\line \line {\b New 
hope in fight against advanced lung cancer} \line Roche files marketing application for 
Tarceva with European health authorities\line \line Roche today submitted a Marketing 
Authorisation Application to the European health authorities for its new cancer drug Tarceva (erlotinib) 
for the treatment of advanced non-small cell lung cancer (NSCLC). NSCLC is the most common form of lung 
cancer, which in itself is the most frequent cancer world wide. The application is based on data from 
a pivotal clinical trial involving more than 700 patients with advanced NSCLC who had failed first or 
second-line chemotherapy. Patients with advanced NSCLC treated with Tarceva achieved a significant improvement 
(42%) in survival compared to those on placebo, along with improved symptom benefit{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} .\line \line \u8220?The 
benefits of Tarceva in this patient group are very compelling. Tarceva represents the first significant 
advance in survival, among targeted therapies, for lung cancer patients who have failed available chemotherapy. 
In the study, one out of three patients on Tarceva was alive at one year as opposed to only one of 
five in the placebo group. We will work closely with regulatory authorities to bring Tarceva to patients 
as quickly as possible\u8221? said William M Burns, Head of Roche Pharmaceuticals Division.\line \line Lung 
cancer is the most common cancer worldwide, accounting for 1.2 million new cases annually{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
with someone, somewhere dying of lung cancer every 30 seconds.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  
NSCLC accounts for almost 80 percent of all types of lung cancer and has few treatment options. \line \line Tarceva 
is the first and only EGFR-targeted anticancer treatment to have shown a significant survival prolongation 
in lung cancer. An application for approval of Tarceva in advanced NSCLC was also filed with the US 
FDA this month.\line \line {\b Study Details} \line The 
EU filing is based on results of the pivotal Phase III randomised trial (BR21) involving 731 patients, 
which compared the use of Tarceva versus 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%.1 The study also 
met all of its secondary endpoints including improving time to symptomatic deterioration, progression-free 
survival and response rate. 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. Results 
of a Phase III trial of Tarceva in pancreatic cancer are expected during the second half of 2004 and 
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 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 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.\line \line {\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.\line \par}\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}
}