Cell Genesys to build 41,000 square foot manufacturing facility

Site will boast product launch capability

Cell Genesys Inc. (CGI) has begun construction of a multi-product GMP (Good Manufacturing Practices) manufacturing facility in Hayward, California, just down the road from its Foster City headquarters. The new facility will meet CGI's clinical production requirements for Phase III studies as well as potential product launches. The 41,000 square foot plant will manufacture CGI's GVAX cancer vaccines and other gene therapy products for hemophilia, cancer, and other indications. CGI expects the plant to be fully validated and on-line by mid-2002.

CGI has designed the new facility to produce multiple products concurrently. For example, CGI will require manufacturing capacity for cell-based pharmaceuticals, such as GVAX cancer vaccines, as well as for DNA or RNA-based gene therapy products. CGI is installing large-scale fermentation equipment, expanding its current production capacity to multiple 500-liter production lines.

"The substantial expansion of our manufacturing capabilities is driven by our progress across multiple areas of product development, particularly our most advanced clinical stage programs in GVAX cancer vaccines," said Stephen A. Sherwin, chairman and CEO of CGI. "Our considerable financial resources, including both an expected year-end cash balance of more than $250 million and a 10.5% equity interest in Abgenix, a former subsidiary, give us the flexibility to make this strategic investment in manufacturing infrastructure."

GVAX vaccine platform
GVAX vaccines are made from tumor cells which have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone that stimulates an immune response to vaccines. The genetically modified cells, which are irradiated (so they won't cause illness) before administration, stimulate an immune response against their cancer. GVAX cancer vaccines, which have been safely administered to more than 300 patients, show antitumor effects in each of the human cancers in which they have been tested: prostate cancer, pancreatic cancer, lung cancer, renal cancer, and melanoma. Cell Genesys recently announced that an initial Phase II trial of GVAX prostate cancer vaccine demonstrated evidence of anti-tumor activity in patients with advanced metastatic prostate cancer who had failed standard hormone therapy.

CGI is planning additional trials for pancreatic cancer, myeloma, and leukemia, indications for which CGI should begin clinical trials in early 2001. CGI will make most of its cell-based products at the Hayward facility.

In addition to GVAX, CGI's most advanced therapy platform, the company has ongoing preclinical programs for gene therapy in hemophilia, cancer, cardiovascular disease, and Parkinson's.

For more information: Jennifer Cook Williams, Cell Genesis, 342 Lakeside Dr., Foster City, CA 94404. Tel: 650-425-4542. Fax: 650-425-4457.

Edited by Angelo DePalma
Managing Editor, Drug Discovery Online and Pharmaceutical Online
adepalma@vertical.net