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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, June 3, 2006\line \line {\b New 
data show impressive 
survival benefit for Herceptin in early-stage HER2-positive breast cancer} \line \line Follow-up 
from 
the international HERA trial continues to demonstrate significant patient benefits from Herceptin \line \line New 
23-month follow-up data from HERA, one of the largest breast cancer trials ever carried out, show that 
Herceptin (trastuzumab) following standard chemotherapy significantly reduced the risk of death by 34% 
for women with early-stage HER2-positive breast cancer.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
The data also show that Herceptin continues 
to provide patients with a reduced risk of their cancer coming back. HER2-positive breast cancer, which 
affects approximately 20% \u8211? 30%{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  of women 
with breast cancer, demands special and immediate attention 
because the tumours are fast-growing and there is a higher likelihood of relapse. \line \line The 
data from the international HERA (HERceptin Adjuvant) study were presented today at the American Society 
of Clinical Oncology (ASCO) annual meeting in Atlanta, the biggest conference for oncologists worldwide. 
These follow-up data showed that Herceptin taken for 12 months increases the chance of long-term survival 
by preventing the development of advanced (metastatic) disease. Similar disease-free and overall survival 
benefits from Herceptin in this setting have also been seen in two large US trials,{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  
but the HERA 
study allowed for the use of a wide range of standard chemotherapy regimens before treatment with Herceptin, 
making these results highly meaningful to many parts of the world.\line \line Professor 
Ian Smith, Head of the Breast Unit at Royal Marsden Hospital, London, UK, and investigator of the HERA 
study, commented, \u8220?These significant survival results for Herceptin in the early breast cancer are very 
important. Last year\u8217?s HERA results showed that Herceptin could reduce the risk of recurrence; now we 
have confirmation for the first time that this means a better chance of staying alive. HER2-positive 
breast cancer is a more aggressive form of the disease, and it is very important that women diagnosed 
with early breast cancer have a HER2 test to see if they would benefit from Herceptin.\u8221? \u160?\u160?\line \line Roche 
filed for an indication of Herceptin in early-stage HER2-positive breast cancer in February 2006 based 
on the interim analysis of the 12-month arm of the HERA data. The European Commission granted approval 
for this indication on May 22, 2006. \line \line {\b About the HERA study} \line The 
HERA study is a randomised, phase III trial, which evaluated the use of Herceptin versus observation 
following a wide range of primary chemotherapy (chemotherapy given before or after surgery) and radiotherapy 
(if applicable) for 12 or 24 months in women with early-stage HER2-positive breast cancer. The 23-month 
follow-up data show that patients who received Herceptin in the 12-month arm had statistically significant 
reductions in the risk of death (hazard ratio = 0.66), as well as the risk of cancer coming back (hazard 
ratio = 0.64). \line \line The HERA study has an external Independent Data Monitoring 
Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC, and 
the incidence of severe congestive heart failure was very low (0.6% in the Herceptin arm vs. 0% in the 
observation arm). Patients in this study continue to be followed for any side effects. \line \line HERA, 
conducted by the Roche and the Breast International Group (BIG),{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}}  
is one of the largest adjuvant 
studies ever carried out among breast cancer patients; enrolment to the trial began in December 2001, 
and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world. 
The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive 
and lymph node-negative patients were eligible for entry into the trial.\line \line The 
analysis of the 23-month follow-up compared Herceptin versus observation and did not include a comparison 
of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison 
and data will become available in due time as the study matures.\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.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 5\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 In HER2-positive breast cancer, increased quantities of the HER2 protein 
are present on the surface of the tumour cells. This is known as \u8216?HER2 positivity.\u8217? High levels of HER2 
are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. 
Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer. \line \line Herceptin 
is a humanised antibody, designed to target and block the function of HER2, a protein produced by a 
specific gene with cancer-causing potential. In addition to its efficacy in the early-stage breast cancer 
setting, Herceptin also has demonstrated improved survival in the advanced (metastatic) setting, where 
its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 6\par}}  
\line \line Herceptin received approval in the European Union in 2000 for 
use in patients with metastatic (advanced) breast cancer, whose tumours overexpress the HER2 protein. 
It is indicated for use as first-line therapy in combination with docetaxel in patients who have not 
received chemotherapy for their metastatic disease, first-line therapy in combination with paclitaxel 
where anthracyclines are unsuitable, and third-line therapy as a single agent. As of May 2006, Herceptin 
is also approved in the European Union as adjuvant therapy following standard chemotherapy for early-stage 
HER2-positive breast cancer. \line \line Herceptin is marketed in the United States 
by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to 
treat over 230,000 HER2-positive breast cancer 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 \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in 
this release are legally protected.\par}\line \line {\b Additional 
information:} \line - About Genentech (http://www.gene.com)\line - Roche 
in Oncology (http://www.roche.com/mboncology-e.pdf)\line - Roche Health Kiosk 
on cancer (http://www.health-kiosk.ch/start_krebs)\line - Video clips (http://roche.synapticdigital.com) - in 
broadcast standard, 
free of charge\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References\line 1 
\u160?Smith I, E. et al. Trastuzumab following adjuvant chemotherapy in HER2-positive early breast cancer 
(HERA trial): disease-free and overall survival after 2 year median follow-up. Scientific Special Session, 
American Society of Clinical Oncology (ASCO) Annual Meeting 2006.\line 2 \u160?Harries M, 
Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 
2002.\line 3 \u160?Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant Chemotherapy for 
Operable HER2 Positive Breast Cancer. New England Journal of Medicine 353:16 2005.\line 4 
\u160?Collaborative partners for the HERA study include: Roche, BIG and its affiliated collaborative 
groups, plus non-affiliated collaborative groups, and independent sites. \line 5 \u160?World 
Health Organization, 2000.\line 6 \u160?Extra JM, Cognetti F, Maraninchi D et al. Long-term 
survival demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised trial (M77001) 
in HER2-positive metastatic breast cancer. Abstract #555, American Society for Clinical Oncology (ASCO) 
Annual Meeting 2005.\par}\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}
}
