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{\pard\sa900\fs50\f0\i Media Release\par}
Basel, 13 October 2006\line \line {\b Roche files Herceptin 
plus hormonal therapy for advanced HER2-positive breast cancer with European Authorities} \line \line Roche 
announced today the submission of a Marketing Authorisation to the European Medicines Agency (EMEA) 
for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone receptor-positive breast 
cancer. The application is based on data from the international TAnDEM study which showed that the addition 
of Herceptin to hormonal therapy doubles the median progression-free survival (amount of time a patient\u8217?s 
cancer is kept under control), from 2. 4 months to 4.8 months.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}}  
\line \line HER2-positive breast cancer, which affects 20 to 30 percent of women 
with breast cancer, is an aggressive form of the disease that requires special and immediate attention 
because the tumours are fast-growing and there is a higher likelihood of relapse.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
Up to a half of HER2-positive breast cancers are also hormone receptor-positive, a form of the disease 
that has typically been considered \u8216?lower-risk,\u8217? due to successful treatment with hormonal therapies.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 3\par}}  
However, TAnDEM is the first randomised study to show that this specific subset of \u8216?co-positive\u8217? patients 
(both HER2- and hormone receptor positive) is actually \u8216?higher-risk\u8217?, making the positive results with 
Herceptin even more meaningful. \line \line \u8220?The results from the TAnDEM study show 
once again that Herceptin should be the backbone for all HER2-positive breast cancer patients \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,\u8221? said Eduard Holdener, 
Global Head of Roche Pharma Development. \u8220?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.\u8221? \line \line {\b About the 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 randomized 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 {\pard\f0\li0\ri0\sa360\sl360\fs18 4\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 percent 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. 
It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on 
its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin 
has been shown to improve response rates, disease-free survival and overall survival while maintaining 
quality of life in women with HER2-positive breast cancer.\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 now 
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 310,000 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 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, while 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 protected by law.\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 \line To 
access video clips (http://www.thenewsmarket.com/), in broadcast standard, free of charge. \line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References\line 1 
\u160?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 \u160?Harries M, Smith I. The development 
and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.\line 3 \u160?Marty 
M, Cognetti F, Maraninchi D, et al. Efficacy and Safety of Trastuzumab Combined with Docetaxel in Patients 
with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Administered as First-Line 
Treatment: Results of a Randomised Phase II Trial by the M77001 Study Group. J Clin Oncol. 2005;23:4265-4274\line 4 
\u160?World Health Organization, 2000.\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}
}