West Coast Editor

Its gene-activation technology garnered Cell Genesys Inc. a deal worth $26 million in cash and stock with Transkaryotic Therapies Inc., which plans to use the approach with up to 15 therapeutic proteins.

Although the technology helped establish Foster City, Calif.-based Cell Genesys, "it's something we never have used, as we became more of a traditional gene therapy company," Robert Tidwell, vice president of corporate development, told BioWorld Today.

"We quickly changed our therapeutics and production focus," he added. "It really hasn't fit into our plan, although obviously it's important to other people."

The deal with TKT is the largest ever for the technology. Under its terms, Cell Genesys gets $11 million in an up-front license fee and $15 million in TKT's common stock, and more if patent-related milestones are reached.

Since 1994, Cell Genesys has been entering deals with other firms for the technology. Not including the TKT arrangement, such deals have raised more than $25 million so far - perhaps most famously with Aventis Pharma AG, of Frankfurt, Germany, for gene-activated erythropoietin, which led to the ongoing court skirmish between TKT/Aventis and Amgen Inc., of Thousand Oaks, Calif., over EPO products. (See BioWorld Today, March 27, 2002.)

The new deal with TKT includes Fabry's disease and Gaucher's disease, the former of which also has been the subject of TKT litigation. In the winter of 2000, a federal judge dismissed patent litigation brought against TKT by Cambridge, Mass.-based Genzyme General over Replagal (agalsidase alfa), TKT's enzyme-replacement therapy for Fabry's. (See BioWorld Today, Dec. 18, 2000.)

For its part, Cell Genesys focuses on gene therapy for cancer and has three cancer product platforms: GVAX cancer vaccines and in vivo cancer gene therapies.

GVAX vaccines, which have advanced to the Phase II stage, are undergoing clinical trials in lung cancer, prostate cancer, pancreatic cancer, leukemia and myeloma. The lung cancer vaccine is expected to enter Phase III this year, "quickly followed in the first half of 2003 for prostate cancer," Tidwell said.

"I think it would be safe and accurate to say the two lead candidates, GVAX for prostate and lung cancers, would be the major focus on the company," Tidwell said. "Certainly not far behind are some of the oncolytic [treatments] we acquired last year form Calydon [Inc.]," for which Cell Genesys agreed to pay $17.4 million in stock. (See BioWorld Today, Aug. 3, 2001.)

Oncolytic virus therapies include CG7060 and CG7870 in prostate cancer, also in clinical trials, with CG7060 expected to reach Phase III in the second half of next year. Gene therapies for various cancers are in the preclinical stages.

Cell Genesys' stock (NASDAQ:CEGE) closed Monday at $13.24, down 3 cents. TKT's shares (NASDAQ:TKTX) ended the day at $34.97, up $1.47.