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."

CGI is conducting clinical trials to evaluate GVAX in prostate and lung cancers, and 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, Pharmaceutical Online and Drug Discovery Online
adepalma@vertical.net