Cell Genesys Inc. is licensing its gene-activated, follicle-stimulating hormone (FSH) to the Swiss company Theriak A.G.,a subsidiary of Akzo Pharma International B.V. The product,for use in the treatment of infertility, is in preclinical testing.

Theriak will take over development of the hormone, conductclinical trials and have worldwide marketing rights. CellGenesys of Foster City, Calif., will receive undisclosed licensingfees, royalties and other payments. In addition, Cell Genesyswill have the right of first refusal to manufacture bulk materialfor the worldwide market and the option to co-promote theproduct in the U.S. Financial terms of the deal were notdisclosed.

FSH is the only gene-activated product that Cell Genesys hasdisclosed it is developing. The company said its proprietarygene-activated technology works by inserting geneticregulatory elements capable of activating genes at specific sitesin chromosomes near the human gene to be activated. Theactivated gene then makes the protein of interest, which thencan be produced in a cell-based production system forcommercialization.

Another way to produce a protein is through gene cloning andrecombinant technology. Cell Genesys said gene activationeliminates the sometimes difficult and time-consuming processof cloning entire human genes, and also may offer certainproduction advantages. The company noted that FSH-typeproducts purified from human urine have been used since the1960s to treat infertility.

Ares-Serono of Geneva, Switzerland, and Organon InternationalB.V., a business unit of Akzo, are developing recombinanthuman FSH. Ares-Serono filed a new drug application for itsproduct, Gonal-F, in December. It is intended for use in womenundergoing in vitro fertilization and embryo transfer.

Ares-Serono announced earlier this month that it won a patentsuit against Organon in Europe. Ares-Serono said the court ofappeals in The Hague, Netherlands, had granted a preliminaryinjunction against Organon's infringement of its recombinantFSH European patent. Ares-Serono said Organon must stopmanufacture, use, delivery and/or maintenance of r-FSH inAustria, Belgium France, Germany, Liechtenstein, Luxembourg,Switzerland, Sweden, the Netherlands and the United Kingdom.

-- Brenda Sandburg News Editor

(c) 1997 American Health Consultants. All rights reserved.