BASEL, Switzerland, July 8, 2003 (PRIMEZONE) -- Roche confirmed today that Roche has licensed the rights to Avastin (bevacizumab, rhuMAB-VEGF) for all countries outside the U.S., under the existing agreement with Genentech. Genentech will retain all rights to market the product in the US.
Genentech is pursuing a broad late-stage clinical development program with Avastin including its potential use in the treatment of metastatic colorectal cancer. Positive results of a Phase III study were presented at the American Society of Clinical Oncology in Chicago in May. The study, which was one of the largest metastatic colorectal cancer trials ever conducted, showed that patients treated with Avastin plus the standard of care chemotherapy experienced a marked improvement in survival when compared to patients who received chemotherapy alone.
In addition to being developed for colorectal cancer, Roche and Genentech will jointly develop Avastin in other tumor types (e.g. renal cell carcinoma, Non-Small Cell lung cancer, and metastatic breast cancer). Clinical trials for Avastin are ongoing covering other solid and hematological tumors.
"We are very excited about this agreement, as Avastin is an ideal supplement to our existing range of highly innovative and effective cancer medicines. It also confirms the strengths of our decade-long network strategy with Genentech that shows impressive results." said Franz B. Humer, Chairman and CEO of Roche. "The combined R&D resources of Roche, Genentech and Chugai form the core of our Group's innovation capacity. Together with our network of strategic alliances and partnerships we build a strong team enabling us to offer new options in areas of unmet medical needs."
"Avastin will be a significant advancement in the treatment of cancer as it provides a compelling survival benefit in patients with metastatic colorectal cancer. It will be the fourth Roche oncology drug extending cancer patient's life and bringing new hope to patients and their families," said William M. Burns, Head of Roche's Pharmaceuticals Division.
"With this agreement for Avastin, we look forward to continuing our successful relationship with Roche in the development and commercialization of novel targeted therapies for cancer that can provide clinical benefit to patients around the world," said Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, Development and Product Operations, and chief medical officer.
About Avastin
Avastin (rhuMAb VEGF) - recombinant humanized therapeutic antibody - inhibits Vascular Endothelial Growth Factor (VEGF), a protein that is believed to play an important role in tumor angiogenesis. By inhibiting VEGF, Avastin interferes with the blood supply to tumors and thereby inhibiting tumor growth, and potentially leading to tumor regression. It represents a promising, novel anti-cancer approach with a broad potential applicability in a number of solid tumors, and it is likely to be complementary with current chemotherapy approaches.
About the study: Avastin Metastatic Colorectal Cancer Trial Overview and Safety Results Avastin was evaluated in a randomized multi-center Phase III study enrolling more than 900 patients with previously-untreated metastatic colorectal cancer patients. Patients receiving Avastin plus chemotherapy had a 50 percent increase in their chance for survival compared to patients who received chemotherapy alone. Conversely, this corresponds to a hazard ratio of 0.65 (p=0.00003). This benefit represents an extension in the median survival of patients treated with Avastin plus chemotherapy by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months).
About Colorectal Cancer
Colorectal cancer is the third most common cancer in men and women representing 10 - 15 percent of all cancers. In 2000, the World Health Organization reported that almost 950,000 people worldwide were diagnosed with colorectal cancer and half of the patients died. In Europe, almost 365,000 patients are newly diagnosed with colorectal cancer each year.
Roche in Oncology
Within the last five years Roche has become the worlds lead supplier of medicines for oncology. Its franchise includes Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), Xeloda (colorectal cancer, breast cancer) NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma) and Kytril (chemotherapy and radiotherapy-induced nausea) and sales in 2002 exceeded 5 billion Swiss francs. Roche Oncology has four research sites (two in the US, Germany and Japan) and four HQ Development sites (two in the US, UK and Switzerland) dedicated to Oncology. Roche also offers a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests running on the LightCycler. Within its Integrated Cancer Care Unit the company develops new tests which will have a significant impact on disease management of cancer patients in the future.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
About Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 11 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
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Additional information on Avastin: - Drug description: http://www.gene.com/gene/pipeline/status/oncology/avastin/index.jsp
- Avastin clinical studies: http://www.gene.com/gene/pipeline/trials/
- June 1st: Positive Results from Phase III Avastin Study in Metastatic Colorectal Cancer: http://www.gene.com/gene/news/press-releases/detail.jsp?detail=6247
- June 26th: Genentech Receives FDA Fast-Track Designation for Avastin http://www.gene.com/gene/news/press-releases/detail.jsp?detail=6367