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Investor Update

Basel, 28 July 2008

Avastin filed for broader breast cancer label in Europe

Roche announced today that they have submitted an application to the EMEA to extend the current European label of Avastin (bevacizumab) in patients with metastatic breast cancer to include its use in combination with docetaxel chemotherapy. If granted, the new label will allow even more patients to get access to the benefits provided by Avastin. The proposed new label will give physicians more choice and treatment flexibility as it will allow Avastin to be combined with two commonly used taxane chemotherapies (paclitaxel and docetaxel). This filing is important because docetaxel is the chemotherapy of choice for many European physicians.

The new filing is supported by data from the phase III AVADO study. AVADO investigated Avastin in combination with docetaxel compared to docetaxel alone in the first-line treatment of patients with metastatic breast cancer. Avastin was administered at either 7.5 or 15 mg every 3 weeks. The trial demonstrated that both doses of Avastin in combination with chemotherapy significantly increase the time patients live without their disease advancing (progression-free survival) compared to chemotherapy alone. The high dose Avastin yielded numerically higher activity without impacting the tolerability.

Avastin is currently licensed in the EU as first-line treatment in patients with metastatic breast cancer in combination with paclitaxel. The current label is based on the results from the pivotal E2100 trial, which showed that the addition of Avastin to paclitaxel doubled patients’ chances of being alive without disease progression compared to paclitaxel alone. In addition, these results formed the basis of the FDA’s decision to grant an accelerated approval for Avastin in the USA for first-line treatment of HER-2 negative metastatic breast cancer in February 2008.

Each year more than one million women are diagnosed with breast cancer worldwide, and over 400,000 of these women die from their disease.1

About the AVADO study

AVADO is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups,

  • Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
  • Avastin 15 mg/kg every 3 weeks in combination with docetaxel
  • docetaxel + placebo as control arm
  • The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin-containing treatment arms compared to the control arm. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety and tolerability.

The results of the phase III “Avastin and Docetaxel” (“AVADO”, BO17708) study were presented at the recent American Society of Clinical Oncology (ASCO) meeting in June 2008 and showed that the combination of Avastin and docetaxel resulted in:

  • Up to 64% improved PFS (hazard ratio of 0.61; p=0.0001) in the 15 mg/kg treatment arm and up to 45 percent (hazard ratio of 0.69; p=0.0035) in the 7.5 mg/kg treatment arm, compared to docetaxel alone.
  • Up to two thirds of patients (63%) experiencing major shrinkage of their tumor, which is unprecedented (p=0.0001).
  • After one year, 83 percent and 78 percent of patients were alive in the 15mg/kg and 7.5 mg/kg Avastin treatment arms, compared to 73 percent of patients receiving chemotherapy alone. The study protocol specified analyses for overall survival at the time of primary endpoint analysis and 24 months after the last patient was enrolled.  The final analysis for overall survival is expected in 2009.  Hazard ratios for the preliminary analysis of overall survival are 0.68 and 0.92 for the 15 mg/kg and 7.5 mg/kg Avastin arms, respectively.  These initial results for overall survival are  based on early information.
  • No new or unexpected safety signals related to Avastin. Furthermore, Avastin did not have a major impact on the known toxicity profile of docetaxel.

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 renal cell 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 80,000 people. Additional information is available on the Internet at www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1) Parkin M,  Bray F,  Ferlay J, and Pisani P: CA Cancer J Clin 2005;55;74-108

Additional information

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