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Investor Update

Basel and South San Francisco, 1 April 2009

FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS ACCELERATED APPROVAL OF AVASTIN FOR PREVIOUSLY TREATED BRAIN CANCER (GLIOBLASTOMA)

Genentech, Inc. announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin® (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit.  The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009.  

“We look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade,” said David Schenkein, M.D., senior vice president, Clinical Hematology and Oncology, Genentech.  “A global Phase III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later this year.”  

About Glioblastoma

Glioblastoma affects approximately 10,000 people per year in the United States. Following initial treatment, glioblastoma tumors nearly always return and there are currently no widely accepted non-surgical medicines when these relapses occur.

According to historical estimates, fewer than 10 percent of patients respond to treatment and approximately 10 to 20 percent will live six months without their disease getting worse.  Glioblastoma tumors invade brain tissue and can impact physical activities and mental abilities.

Avastin Application for Accelerated Approval

An accelerated approval of Avastin for previously treated glioblastoma would provide doctors with safety and efficacy information and give people with this rapidly progressing brain cancer a new option.  The application is based on positive, independently reviewed data from the non-comparative Phase II BRAIN study (AVF3708g) of 167 patients.  In the 85 patients treated with Avastin alone, the trial showed:

  • In 28 percent, tumors shrank to at least half their original size;
  • In those whose tumors shrank, half experienced a response of at least 5.6 months;
  • 43 percent lived six months without their disease getting worse; and,
  • Half lived at least 9.3 months after starting treatment with Avastin and 38 percent survived longer than one year.

No new safety signals were observed in the trial and the safety profile was consistent with Avastin experience in other tumor types.  The most common severe (Grade 3 or greater) adverse events in patients treated with Avastin alone were high blood pressure (8 percent) and seizures (6 percent).  There were two deaths associated with adverse events in the group of patients treated with Avastin alone.

AVF3708g was an open-label, multicenter study that evaluated Avastin alone or in combination with irinotecan in previously treated glioblastoma.  

All patients had previously progressed on prior temozolomide and radiation.  The two primary endpoints of the study were objective response rate and six-month progression-free survival (PFS).  Response rate was defined as a decrease in tumor size by at least 50 percent on two consecutive independent assessments at least four weeks apart.  Six-month PFS was defined as the number of patients who lived six months without their disease getting worse.  Secondary endpoints included overall survival and safety.  

About Avastin

Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis.  Glioblastomas express high levels of VEGF and develop an extensive network of tumor blood vessels.  VEGF is a potent activator of angiogenesis throughout the lifecycle of a tumor and is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).  

Avastin is approved for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel.

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 2008 sales by the Pharmaceuticals Division totaled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interest in Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.