{\rtf1\ansi\ansicpg1252\cocoartf949\cocoasubrtf430
{\fonttbl\f0\froman\fcharset0 TimesNewRomanPSMT;\f1\fswiss\fcharset0 ArialMT;}
{\margl1800\margr1600\margt500\margbl1440}
{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 26 April 2005\line \line {\b Herceptin 
improves survival for the first time in women with early-stage HER2-positive breast cancer} \line \line Joint 
interim analysis of two large phase III clinical trials provides first positive data of a targeted therapy 
after initial surgery\line \line Roche and Genentech today announced that a joint 
interim analysis of two large North American phase III studies showed that the use of Herceptin (trastuzumab) 
significantly increases survival for women with early-stage HER2-positive breast cancer. These results 
provide the first evidence that Herceptin has the potential to reduce the risk of cancer coming back 
at an early stage and to prolong life for women with this aggressive form of the disease. \line \line \u8220?These 
results in early-stage HER2-positive breast cancer suggest that Herceptin may increase the chance of 
long-term survival by preventing the development of metastatic disease, and while further follow-up 
is necessary, they offer new hope to women suffering from this particularly aggressive form of breast 
cancer,\u8221? said William M. Burns, CEO of Roche\u8217?s Pharmaceuticals Division. \u8220?Given these latest data, determining 
HER2 status as soon as a patient is diagnosed is becoming an essential step in the management of breast 
cancer.\u8221? \line \line The two studies evaluated the use of Herceptin plus chemotherapy 
compared to chemotherapy alone following initial surgical treatment (adjuvant treatment). The joint 
interim analysis met its specified primary and secondary endpoints by showing statistically significant 
improvements in disease-free survival (the length of time after treatment during which no disease is 
found) and overall survival. According to the National Cancer Institute (NCI), these results will be 
presented at the American Society of Clinical Oncology (ASCO) annual meeting, May 13 \u8211? 17, 2005.\line \line Dr 
Martine Piccart, Head of the Medicine Department at the Jules Bordet Institute in Brussels and lead 
investigator of the HERA ({\b HER} ceptin {\b A} djuvant) study, another 
large Herceptin adjuvant trial, commented, \u8220?The medical community has eagerly awaited results of Herceptin 
in the early-stage breast cancer setting, and these interim data demonstrate for the first time that 
a targeted therapy has a clinical benefit in early-stage HER2-positive breast cancer. The news of these 
North American trials also heightens anticipation around the upcoming interim analysis of the HERA study, 
which similarly investigated Herceptin in early breast cancer, but with a wider range of chemotherapy 
regimens.\u8221? \line \line Herceptin has already demonstrated improved survival in the 
advanced (metastatic) setting, where its addition to first-line chemotherapy allows patients to live 
up to one-third longer than chemotherapy alone. Since 1998, Herceptin has been used to treat over 230,000 
metastatic HER2-positive breast cancer patients worldwide. HER2-positive breast cancer affects approximately 
20 \u8211? 30% of women with breast cancer and is a particularly aggressive form of the disease with a poor 
prognosis.{\super {\pard\f0\li0\ri0\sa360\sl360\fs18 1\par}} \line \line {\b About 
the NCCTG and NSABP studies} \line The two studies were sponsored by the NCI, part of 
the National Institutes of Health, and conducted by a network of researchers led by the National Surgical 
Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), who 
conducted this prospectively-designed joint interim analysis. The NCCTG study enrolled its first patient 
in June 2000 and has enrolled 3,406 patients to date; the NSABP study began enrolment in March 2000 
and has enrolled 2,085 patients to date. The joint interim analysis was based on information from 3,300 
patients. These studies will stop enrolling new patients and the cooperative groups will continue to 
monitor patients for longer-term data. Each of the studies was a randomised, controlled trial that evaluated 
the combination of doxorubicin and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin 
using different treatment schedules of paclitaxel in women with early stage HER2-positive breast cancer. 
\u160?\line \line Adverse events in these studies were consistent with those seen 
in previous Herceptin clinical trials. Each of these studies has an independent, external Data Monitoring 
Committee (DMC) that reviewed data from the studies, including cardiac safety data. The DMCs monitored 
safety data on a regular basis and there were three to four percent more cases of serious or life-threatening 
(and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the 
heart muscle), in patients receiving the combination of Herceptin plus chemotherapy. These findings 
have been reported previously. Patients in these studies will continue to be followed for any additional 
side effects. \line \line {\b About the HERA study} \line Enrolment 
to the HERA trial, conducted by the Breast International Group (BIG){\super {\pard\f0\li0\ri0\sa360\sl360\fs18 2\par}}  
and Roche, began in December 2001, and nearly 5,100 patients have been enrolled at 480 sites in 39 countries 
across the world. HERA is a randomised trial which evaluates the use of standard adjuvant systemic chemotherapy 
and radiotherapy (if applicable), followed with or without Herceptin every three weeks for 12 or 24 
months in women with early stage HER2-positive breast cancer. \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 3\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. \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. \u160?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 disease, it is also indicated as a first-line therapy in 
combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in second- and 
third-line therapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and 
internationally by Roche.\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 
2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics 
Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 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.\line \par}\line \line {\b Further 
information:} \line - Herceptin: www.HER2status.com (http://www.her2status.com) and www.heratrial.com (http://www.heratrial.com)\line - 
Genentech (http://www.gene.com): www.gene.com\line - Cancer (http://www.health-kiosk.ch/start_krebs): www.health-kiosk.ch\line - 
Roche in Oncology (http://www.roche.com/mboncology-e.pdf): www.roche.com/pages/\line downloads/company/pdf/mboncology05e_a.pdf\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 References:\line 1. 
\u160?Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat 
Cancer 9: 75-85, 2002.\line 2. \u160?Collaborative partners for the HERA study include: Roche, 
the Breast International Group (BIG) and its affiliated collaborative groups, plus non-affiliated collaborative 
groups, and independent sites\line 3. \u160?World Health Organization, 2000\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}
}