Tuesday, Aug 10, 2004
South San Francisco and Vacaville, Calif. -- August 10, 2004 --Genentech, Inc. (NYSE: DNA) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for the manufacturing of Avastin (bevacizumab) bulk drug substance at the company's facility in Vacaville, Calif. Avastin was approved by the FDA in February 2004 to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a first-line treatment for metastatic colorectal cancer and is the first FDA-approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis.
"The FDA approval for Avastin bulk drug production at our Vacaville facility is an important step in ensuring that there is sufficient supply available for patients who need Avastin," said David A. Ebersman, senior vice president, Product Operations. "We are pleased with the successful transfer of the Avastin process and appreciate the diligent efforts by our employees and the FDA to secure the approval of this filing."
Avastin bulk drug substance will continue to be manufactured at the company's South San Francisco facility, as well as at the Vacaville facility.
The current Vacaville site has a manufacturing capacity of 144,000 liters and was originally licensed by the FDA in April 2000. The facility is licensed to produce bulk drug substance for Avastin, Herceptin® (Trastuzumab), Rituxan® (Rituximab) and Xolair® (Omalizumab).
Avastin is a therapeutic antibody designed to inhibit VEGF, a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By binding to VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis. Avastin received approval by the FDA on February 26, 2004, to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for first-line metastatic colorectal cancer. For full prescribing information, Boxed Warnings on Avastin and information about angiogenesis, visit www.gene.com or call 800-821-8590. For more information about Avastin, visit www.avastin.com.
Avastin Safety Profile
In Genentech-sponsored studies, the most serious adverse events associated with Avastin were gastrointestinal perforation, wound healing complications, hemorrhage, hypertensive crisis, nephrotic syndrome, and congestive heart failure. The most common Grade 3-4 adverse events (occurring in greater than 2 percent of patients in the Avastin arm, compared to the control group) were asthenia, pain, hypertension, diarrhea and leukopenia. The most common adverse events (occurring in greater than 2 percent of patients in the Avastin arm, compared to the control group) of any severity were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For press releases and additional information about the company, please visit http://www.gene.com.
The statement made in this press release related to ensuring sufficient supply of Avastin is forward-looking and actual results could differ materially. Among other things, the supply of Avastin could be affected by a number of factors, including problems with Genentech's or a contractor's manufacturing process, insufficient capacity, a prolonged interruption in the operations of Genentech's or a contractor's manufacturing facilities, the inability of a supplier to provide raw materials, equipment failures or malfunctions, damage to a facility, changes in FDA regulatory requirements or standards, actions by the FDA, a contractor going out of business or failing to produce product or a delay in construction of new facilities. Genentech disclaims any obligation and does not undertake to update or revise the forward-looking statements discussed in this press release.