{\rtf1\ansi\ansicpg1252\cocoartf949\cocoasubrtf430
{\fonttbl\f0\froman\fcharset0 TimesNewRomanPSMT;\f1\fswiss\fcharset0 ArialMT;}
{\margl1800\margr1600\margt500\margbl1440}
{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 22 June 2004\line \line {\b European 
Commission approves Herceptin plus Taxotere as first-line therapy in HER2-positive metastatic breast 
cancer} \line Life-extending combination offers new hope to patients across Europe\line \line Roche 
announced today that the European Commission has approved the use of Herceptin (trastuzumab) in combination 
with Taxotere (docetaxel) in the European Union as a first-line therapy in HER2-positive metastatic 
breast cancer patients who have not yet received chemotherapy for their disease. HER2-positive breast 
cancer patients suffer from a particularly aggressive form of breast cancer which traditionally has 
a poor prognosis. \line \line The approval is based on study results{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 1} \par} 
which showed that for women with HER2-positive breast cancer, the combination of Herceptin and Taxotere 
significantly improved median life expectancy by more than one-third (31 months with Herceptin plus 
Taxotere vs. 22 months for Taxotere alone). The study also showed that 61% of patients treated with 
the combination responded to treatment, compared to 34% of patients who received Taxotere alone. \line \line \u8220?The 
early use of this new combination therapy represents a vital life-extending treatment option for patients, 
and highlights the critical importance of verifying HER2 status upon diagnosis of breast cancer,\u8221? said 
William M. Burns, Head of Roche\u8217?s Pharmaceuticals Division. \u8220?Now that this combination therapy will 
be made available to women across Europe, this further consolidates the position of Herceptin as the 
foundation of care in HER2-positive metastatic breast cancer.\u8221? \line \line In an 
earlier trial, Herceptin also showed a survival benefit when used as a first-line therapy in combination 
with Taxol (paclitaxel). Both Taxol and Taxotere belong to the most commonly used class of chemotherapy 
agents for metastatic breast cancer in Europe, known as \u8216?taxanes\u8217?. This trial with Herceptin and Taxotere 
firmly establishes Herceptin in combination with taxanes as the foundation of care for women with HER2-positive 
metastatic breast cancer. \line \line The aggressive nature of HER2-positive breast 
cancer makes both the survival and response rates highly meaningful. In HER2-positive breast cancer, 
increased quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the 
surface of the tumour cells. This is known as \u8216?HER2 overexpression\u8217?. High levels of HER2 overexpression 
are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. 
Research shows that HER2 overexpression affects approximately 20-30% of women with breast cancer. \line \line {\b About 
the study} \line 188 patients were recruited into the study (M77001), 94 patients randomised 
to receive Herceptin plus Taxotere and 94 randomised to receive Taxotere alone. Two patients in the 
combination arm did not receive study drug and were excluded from the final analysis. Taxotere was scheduled 
at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly 
doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the Taxotere 
arm of the study were given the option to cross over to receive Herceptin, following disease progression. 
\line \line {\b About breast cancer and Herceptin} \line Eight 
to nine percent of women will develop breast cancer during their lifetime, making it one of the most 
common types of cancer in women.{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 2} \par} Each 
year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of 
nearly 400,000 people per year. \line \line Herceptin is a targeted humanised antibody 
treatment that received approval in the European Union in 2000 for use in patients with metastatic breast 
cancer, whose tumours overexpress the HER2 protein. In addition to being indicated for use in combination 
with Taxotere as a first-line therapy in HER2-positive patients who have not received chemotherapy for 
their metastatic disease, it is also indicated as a first-line therapy in combination with Taxol, and 
as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech, 
in Japan by Chugai and internationally by Roche. \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 and Avastin are marketed by Genentech alone and MabThera/Rituxan by Genentech 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, hypercalcemia 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 6 billion Swiss francs in 
2003.\line \line In a recent phase III study Tarceva met its primary endpoint of 
improving overall survival in patients with non-small cell lung cancer. Tarceva is being developed by 
Roche, Genentech and OSI Pharmaceuticals. Chugai is pursuing its development and regulatory approval 
for the Japanese market.\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 innovation-driven healthcare groups. Its 
core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market 
and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. 
As a supplier of 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 employs 
roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements 
with numerous partners, including majority ownership interests in Genentech and Chugai.\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 1 
M77001 12-month update results, presented at the European Breast Cancer Conference in March 2004\line 2\par}{\pard\f0\li0\ri0\sa360\sl360\fs18  
World Health Organisation, 2000\par}\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \line {\b Further 
information} :\line - Herceptin: www.HER2status.com (http://www.her2status.com) 
and www.heratrial.com (http://www.heratrial.com) \line - Cancer disease: www.health-kiosk.ch (http://www.health-kiosk.ch/start_krebs)\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}
}