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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 24 May 2006\line \line {\b Herceptin 
approved in Europe for early use in HER2-positive breast cancer} \line \line Life-extending 
drug offers new hope to women with aggressive form of breast cancer across Europe\line \line Roche 
today announced that the European Commission has approved Herceptin (trastuzumab) for patients with 
early-stage HER2-positive breast cancer following surgery and standard chemotherapy. HER2-positive breast 
cancer, which affects approximately 20% to 30%{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\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 approval is based on 
impressive results from the international HERA (HERceptin Adjuvant) study which showed Herceptin following 
standard chemotherapy significantly reduces the risk of cancer coming back by 46% compared to chemotherapy 
alone.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  Similarly remarkable benefits 
have also been seen in three other major global and US studies.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}} \line \line \u8220?The 
remarkably quick manner in which Herceptin has received European approval in early-stage breast cancer 
is commendable\u8221? commented William M. Burns, CEO of Roche\u8217?s Pharmaceuticals Division. \u8220?Herceptin has 
clearly demonstrated that it provides the best chance of long-term survival when used as early as possible 
in the course of the disease, and this decision is great news for patients and the medical community. 
We will now work with national authorities to ensure that this treatment is accessible to physicians 
and patients throughout Europe.\u8221?\line \line Herceptin was previously approved in 
the EU for the treatment of metastatic (advanced) HER2-positive breast cancer, so this new approval 
allows women with all stages of this aggressive disease, including early-stage breast cancer, to access 
this life-extending treatment option.\line \line The strength of results from four 
large trials with over 12,000 patients has influenced medical and regulatory organizations around the 
world to act urgently to ensure access to Herceptin for early-stage HER2-positive breast cancer patients. 
Herceptin was recently granted approval status in New Zealand and Australia, and several countries over 
the past year have developed clinical guidelines and committed funding to allow eligible patients faster 
access, prior to license. \line \line In the US, Genentech filed a supplemental 
Biologic License Application (sBLA) for the use of Herceptin in early-stage HER2-positive breast cancer 
with the Food and Drug Administration (FDA) on February 15th, 2006. The application is based on data 
from the combined interim analysis of two large US trials,{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 4\par}}  
and Genentech has received a priority 
review designation. \line \line {\b About the HERA study} \line HERA, 
conducted by the Roche and Breast International Group (BIG),{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 5\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. HERA is a 
randomised trial, which, following standard adjuvant systemic chemotherapy and radiotherapy (if applicable), 
evaluates observation versus Herceptin every three weeks for 12 months or 24 months in women with early-stage 
HER2-positive breast cancer. 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 According to the interim analysis, the primary efficacy endpoint was 
met, showing that in the 12-month arm, patients who received Herceptin had a statistically significant 
improvement in disease-free survival (the length of time after treatment during which no disease is 
found). At a median follow-up of one year, the secondary endpoint of overall survival had not reached 
statistical significance, but showed a clear trend towards an improvement in overall survival, which 
is to be confirmed as the data mature.\line \line The interim analysis 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 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 congestive heart failure was very low (0.5% in the Herceptin arms vs. 0% 
in the observation arm). Patients in this study will continue to be followed for any side effects. \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 6\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 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 7\par}}  
\line \line Herceptin 
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 docetaxel 
as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic 
(advanced) disease, it is also indicated as a first-line therapy in combination with paclitaxel where 
anthracyclines are unsuitable, and as a single agent in third-line therapy. 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 {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are legally protected.\par}\line \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 \line 1 
\u160?Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat 
Cancer 9: 75-85, 2002.\line 2 Piccart-Gebhart M, Procter M, Leyland-Jones B, et al. A Randomized 
Trial of Trastuzumab Following Adjuvant Chemotherapy in Women with HER2 Positive Breast Cancer. New 
England Journal of Medicine 353:16 2005.\line 3 \u160?NCCTG N9831 (US), NSABP B-31 (US), BCIRG 
006 (international)\line 4 \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 5 
\u160?Collaborative partners for the HERA study include: Roche, BIG and its affiliated collaborative 
groups, plus non-affiliated collaborative groups, and independent sites. \line 6 \u160?World 
Health Organization, 2000.\line 7 \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}\line \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}
}