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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 3 May 2007\line \line {\b Herceptin approved in Europe 
for use in combination with an aromatase inhibitor for the treatment of patients with HER2 and hormone 
receptor-co-positive metastatic breast cancer} \line The first combination of targeted 
therapies for any cancer to receive approval worldwide\line \line Roche announced 
today that the European Commission has approved the use of Herceptin in combination with an aromatase 
inhibitor for the treatment of postmenopausal patients with HER2 and hormone receptor co-positive metastatic 
breast cancer. \line The approval is based on data from the international phase III TAnDEM 
study which showed that the addition of Herceptin to hormonal therapy doubled the median progression-free 
survival (time patients live without their cancer progressing), from 2.4 months to 4.8 months.{\super 1}  
\line "Today\u8217?s approval means that for the first time a combination of targeted therapies 
is available for patients who suffer from a particularly aggressive form of breast cancer," commented 
William M. Burns, CEO Division Roche Pharmaceuticals. "Herceptin 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." \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. 
TAnDEM is the first randomised study to show that this specific subset of patients with \u8216?co-positive\u8217? 
disease (both HER2- and hormone receptor-positive) are at an increased risk of relapse, making the positive 
results with Herceptin even more meaningful. \line \line Herceptin is currently 
approved for the treatment of early and metastatic (advanced) HER2-positive disease, and has demonstrated 
a survival benefit in both settings. This 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 patients with HER2 and hormone receptor co-positive disease 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 
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 breast cancer cases. \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 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 To date, nearly 400,000 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 (http://www.roche.com).\line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All 
trademarks used or mentioned in this release are protected by law.\par}\line \line \line {\b Additional 
information:} \line - About Genentech (http://www.gene.com) \line - Roche 
in Oncology (http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf) \line - Roche Health Kiosk on cancer (http://www.health-kiosk.ch/start_krebs) \line - 
Video clips, in broadcast standard, free of charge (http://www.thenewsmarket.com/) \line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 1Kaufman, 
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;16:1340-1358.\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;10:5670-5676.\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 
{\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}
}