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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 26 March 2007\line \line {\b Herceptin 
receives positive opinion in Europe for use in combination with an aromatase inhibitor for the treatment 
of patients with HER2- and hormone receptor-positive metastatic breast cancer} \line The 
first combination of targeted therapies for any cancer to receive a positive opinion\line \line Roche 
today announced that the European Union\u8217?s Committee for Human Medicinal Products (CHMP) has issued a 
positive recommendation for the use of Herceptin in combination with an aromatase inhibitor for the 
treatment of postmenopausal patients with HER2- and hormone receptor-positive metastatic breast cancer. 
The recommendation is based on data from the international phase III TAnDEM study which showed that 
the addition of Herceptin to hormonal therapy doubles the median progression-free survival (time patients 
live without their cancer progressing), from 2.4 months to 4.8 months.{\super 1}  \line \line Comprehensive 
reviews have suggested that approximately two thirds of breast tumours are hormone receptor positive{\super 2} . 
Of these, a significant percentage (up to 25%) are also HER2-positive{\super 3,4,5} \line \line TAnDEM 
is the first randomised study to show that this specific subset of 'co-positive' patients (both HER2- 
and hormone receptor-positive) is 'high-risk', making the positive results with Herceptin even more 
meaningful. \line \line "The results from the TAnDEM study show once again 
that 
Herceptin should be the backbone for all patients with HER2-positive breast cancer \u8211? it consistently 
benefits patients regardless of whether it is given in the early- or advanced-stage settings, or whether 
it is in combination with chemotherapy, hormonal therapy, or as a single agent," said Eduard Holdener, 
Chief Medical Officer of Roche. "This combination offers a new treatment regimen for patients who 
suffer 
from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress 
this application so quickly." \line \line The positive opinion proposes the 
approval 
of Herceptin in this combination by the European Commission. Herceptin is currently approved for the 
treatment of early and metastatic (advanced) HER2-positive disease, and has demonstrated a survival 
benefit in both settings. The new approval will also allow Herceptin to be used in combination with 
hormonal therapy for advanced breast cancer.\line \line {\b About the 
TAnDEM study} \line TAnDEM, conducted by Roche, is a randomised, phase III trial, which 
evaluated Herceptin in combination with the hormonal therapy anastrozole versus anastrozole alone as 
first-line therapy (or second-line hormonal therapy) in postmenopausal women with advanced (metastatic) 
HER2-positive and hormone receptor-positive (ER-positive and/or PR-positive) breast cancer. Enrolment 
to the trial began in 2001, and 208 HER2 and hormone receptor co-positive patients were randomised at 
77 centres in 22 countries across the world. \line \line Median progression-free 
survival, the primary endpoint of the trial, was 4.8 months for patients who received the combination 
compared to 2.4 months for patients who received hormonal therapy alone (p = 0.0016). Patients in the 
combination arm also responded significantly better to treatment (overall response rate was 20.3% versus 
6.8%; p = 0.018). There was also a positive trend in median overall survival (28.5 months versus 23.9 
months; p = 0.325); this is despite the fact that in the hormonal therapy alone arm, more than half 
of patients (58/104) crossed over to receive Herceptin during the trial when their disease had progressed, 
and an additional 15 (out of 104) patients received Herceptin at a later time point. \line \line Overall 
safety data in both arms of the trial were acceptable given the known safety profile of each of the 
drugs in the advanced breast cancer setting. 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 6} . 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 7} \line \line Herceptin 
received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer 
in 2000 and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is approved 
for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, 
as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. In 
the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy. Herceptin 
is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. \line \line To 
date, over 350,000 patients with HER2-positive breast cancer have been treated with Herceptin 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 the world\u8217?s 
biggest biotech company and an innovator of products and services for the early detection, prevention, 
diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people\u8217?s 
health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and 
transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune 
diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals 
Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion 
Swiss francs. Roche employs roughly 75,000 worldwide 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 at 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 \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, in broadcast standard, free of 
charge (http://roche.synapticdigital.com)\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 1)Kaufman, B. Trastuzumab 
plus anastrozole prolongs progression-free survival in postmenopausal women with HER2 positive, hormone-dependent 
metastatic breast cancer (MBC). European Society for Medical Oncology (ESMO) Congress, Abstract no. 
LBA2, 2006.\line 2) Chu KC, Anderson WF. Breast Cancer Res Treat 2002;74:199\u8211?211.\line 3) 
Fornier M, Risio M, Van Poznak C, Seidman A. Oncology 2002;16:1340\u8211?1358.\line 4) Penault-Llorca 
F, Vincent Salomon A, Mathieu MC et al. Ann Oncol 2002;13:(Suppl 5):49 (Abstract 176P)\line 5) 
Arpino G, Green SJ, Allred DC et al. Clinical Cancer Res 2004;10:5670\u8211?5676.\line 6) World 
Health Organization, 2000.\line 7) 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}
}