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Investor Update

Basel, 31 May 2008

Benefits of Avastin in metastatic colorectal cancer further substantiated
Two large studies prove strong overall survival benefit in real life setting

A wealth of new Avastin (bevacizumab) data were presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago confirming that Avastin-based therapy is essential for patients with metastatic colorectal cancer (CRC). In total 15 separate data presentations were made with highlights including:

1. Overall survival data confirmed in two large community-based studies, including nearly 4,000 patients
2. First full data presentation of an Avastin and cetuximab combination study

1. Long-term overall survival reported by studies including almost 4,000 patients
The long term benefits of Avastin use  in combination with any chemotherapy at physician’s choice were confirmed by two large community-based studies which collectively included almost 4,000 patients with metastatic CRC. Key findings from the First BEAT and BRiTE studies, presented at ASCO, were:

  • Avastin-based therapy provides a median overall survival benefit for patients of approximately two years (23.5 and 22.7 months from BRiTE and First BEAT respectively). This finding shows that Avastin in daily clinical practice delivers an overall survival benefit in line with or better than observed in Phase III registration trials.
  • Importantly, long-term Avastin exposure did not increase the risk of the patient experiencing Avastin-specific side effects. Incidence of Avastin-specific side effects was consistent with other scientific studies and was even less after one year of treatment.

2. Adding cetuximab to Avastin and chemotherapy decreases the time patients live without their disease getting worse
The first data presentation from the 755 patient CAIRO-2 study, which compared Avastin + chemotherapy (XELOX) versus Avastin + chemotherapy +/-  cetuximab showed:

  • Patients treated with Avastin and chemotherapy lived longer without their disease getting worse (progression-free survival) compared to those treated with cetuximab, Avastin and chemotherapy (median PFS = 10.7 months vs. 9.8 months; hazard ratio of 1.22, p=0.019).
  • Patients in the cetuximab containing arm had a 10% higher incidence of serious side effects, which was mainly attributed to cetuximab-related skin toxicity (p=0.0012).
  • Both arms had comparable median overall survival benefits (20.4 months vs. 20.3 months).

About Avastin
Avastin directly inhibits vascular endothelial growth factor (VEGF), a key mediator of angiogenesis (the growth of new blood vessels). Blocking tumor angiogenesis with Avastin starves the tumor of the blood supply that is critical for its growth and spread throughout the body (metastasis). Because Avastin directly blocks tumor angiogenesis, a process common to all types of tumor development, it has the potential to deliver patient survival benefits in a variety of different cancer types. Roche is therefore pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already resulted in approvals in advanced colorectal, breast, lung, and kidney cancer.

  • February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
  • June 2006 (US) – second-line treatment in patients with metastatic CRC
  • October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer
  • March 2007 (EU) – first-line treatment in patients with metastatic breast cancer (BC)
  • April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
  • December 2007 (EU) – first-line treatment in patients with advanced renal cell cancer
  • January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
  • February 2008 (US) - first line treatment in patients with HER-2 negative metastatic BC

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’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’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.

All trademarks used or mentioned in this release are legally protected.



Additional information
- Roche in Oncology
- Roche Health Kiosk, Cancer
- Avastin

To access video clips about Avastin in broadcast standard, free of charge, please go to: www.thenewsmarket.com