{\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}
Basel, 26 May 2006 \line \line {\b Avastin filed with FDA 
in US for treatment 
of women with advanced breast cancer} \line \line Breakthrough therapy doubles 
the time women live 
without their breast cancer progressing\line \line Roche and Genentech announced 
today that they have filed Avastin (bevacizumab) in the US for the first line treatment of women with 
metastatic (advanced) breast cancer. \u160?Breast cancer is the leading cause of cancer death worldwide 
in women.\line \line \u8220?The addition of Avastin to chemotherapy as a primary treatment 
for metastatic breast cancer doubled the time that women lived without their disease advancing compared 
to patients who received chemotherapy alone.\u8221? said Eduard Holdener, Head of Roche Pharmaceuticals Development. 
\u8220?Breast cancer is now the third type of cancer where Avastin has shown a significant survival benefit. 
This submission marks an important milestone in our ongoing efforts to develop innovative therapies 
for breast cancer patients and to address unmet medical needs.\u8221?\line \line The supplemental 
Biologics License Application (sBLA) has been submitted to the US Food and Drug Administration (FDA) 
for use of Avastin in combination with standard chemotherapy (taxanes) for the first-line treatment 
of women with metastatic breast cancer. \u160?The submission is based on the impressive results of the 
pivotal E2100 Phase III trial which shows that, patients receiving Avastin plus paclitaxel had a median 
progression-free survival (PFS) of more than a year while patients receiving paclitaxel alone had a 
median PFS of approximately six months. A Marketing Authorisation Application (MAA) will be filed with 
the European Authorities later this year.\line \line More than one million women 
are diagnosed with breast cancer each year worldwide and eight to nine percent of women are expected 
to develop breast cancer during their lifetime{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} . 
Breast cancer is the leading cause of cancer 
death in women worldwide under the age of 55{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 2} \par}, 
claiming more than 372,000 lives each year{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} .\line \line Avastin 
is the first and only anti-angiogenic agent to have demonstrated improved overall and/or progression-free 
survival in the three important types of cancer: colorectal cancer, non-small cell lung cancer and breast 
cancer. In Europe, Avastin was approved early 2005 and in the USA in February 2004 for first-line treatment 
of patients with advanced colorectal cancer. Avastin was filed in April in the US for the most common 
form of lung cancer. The first filing for Avastin in Japan has been submitted last month for the treatment 
of advanced colorectal cancer. \line \line {\b About the E2100 study} \line This 
is the first phase III study to evaluate Avastin in combination with chemotherapy for first-line treatment 
of metastatic breast cancer. This randomised, controlled, multi-centre study enrolled 722 women with 
previously untreated metastatic breast cancer. \u160?The study was sponsored by the National Cancer 
Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers 
led by the Eastern Cooperative Oncology Group (ECOG). \u160?The patients were randomised to receive 
treatment with paclitaxel with or without Avastin. \u160?Avastin was given at a dose of 10mg/kg every 
two weeks until disease progression. The results showed that patients receiving Avastin plus paclitaxel 
had a median PFS of more than a year while patients receiving paclitaxel alone had a median PFS of approximately 
six months. \u160?Overall in the trial, patients treated with Avastin plus paclitaxel had a 52 percent 
reduction in the risk of disease progression or death, as expressed by a hazard ratio of 0.48 (1-0.48=0.52 
or 52%), which is also identical to doubling PFS (1/0.48= ~2). Overall survival data for this trial 
are currently immature. \line \line Patients with HER2-positive metastatic breast 
cancer were not enrolled in the study unless they had received prior treatment with Herceptin (trastuzumab) 
or were unable to receive treatment with Herceptin. \u160?Patients who had received adjuvant paclitaxel 
within the previous 12 months and patients with a prior history of blood clots or who were receiving 
blood thinners were also excluded from the study. \line \line {\b About 
Avastin} \line Avastin 
is the first treatment that inhibits angiogenesis \u8211? the growth of a network of blood vessels that supply 
nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF 
(Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply 
that is essential for the growth of the tumour and its spread throughout the body (metastasis).\line \line Roche 
and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various 
tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma 
and others) and different settings (advanced and adjuvant ie post-operation). The total development 
programme is expected to include over 25,000 patients worldwide.\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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss 
francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 
70,000 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 {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\line \par}\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References\line 1 
\u160?World Health Organisation (WHO) 2003. http://www.who.int/mediacentre/releases/2003/pr27/en/)\line 2 
\u160?Brandy A. Box et al. Breast cancer. Manual of clinical oncology, fifth edition, 2004; 233-253\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}
}