Tuesday, August 10, 2004

Genentech gets OK to make cancer drug in bulk in Vacaville


10:04 AM PDT Tuesday, August 10, 2004

Genentech Inc. said Tuesday that the Food and Drug Administration approved the supplemental biologics license application for the manufacturing of Avastin (bevacizumab) bulk drug substance at the company's Vacaville plant.

The South San Francisco-based biotech giant said that Avastin was approved by the FDA in February 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 Ebersman, senior vice president of product operations.

Avastin bulk drug substance will continue to be manufactured at the company's South San Francisco factory.

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).

© 2004 American City Business Journals Inc.

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