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GENZYME ACQUIRES 4% STAKE IN UNIVAX BIOLOGICS

Executive Summary

GENZYME ACQUIRES 4% STAKE IN UNIVAX BIOLOGICS under an R&D/marketing collaboration for treatments of cystic fibrosis- related infections, Genzyme reported Aug. 12. Genzyme is to receive worldwide marketing rights to Univax' immune globulin HyperGAM+ CF, which is being developed for the treatment of cystic fibrosis-related Pseudomonas aeruginosa infections. Genzyme has made an initial equity investment of $5 mil. in the Rockville, Md.-based R&D firm and has agreed to pay up to $6 mil. in milestone and licensing fees. In addition, Genzyme will finance two thirds of the estimated $11 mil. in development costs for the biologic. A portion of Genzyme's payments will be made through Neozyme II, a spin-off of the firm formed in March 1992 to finance R&D of Genzyme's gene therapy and protein replacement treatments for cystic fibrosis ("The Pink Sheet" March 30, 1992, T&G-9). Genzyme's gene therapy protocol is underway, having received FDA clearance July 14. NIH's Recombinant DNA Advisory Committee approved the protocol last December ("The Pink Sheet" Dec. 7, 1992, p. 15). Univax will develop and manufacture HyperGAM+ CF, which is expected to enter a Phase I/II trial in cystic fibrosis patients in early 1994. To produce HyperGAM+ CF, plasma donors are inoculated with a vaccine prepared by Univax. Anti-Pseudomonas antibodies from the donors are then extracted and purified to form HyperGAM+ CF. In a Phase I/II clinical trial of the vaccine, the preparation was "shown to be well-tolerated and to elicit the production, within these donors, of polyclonal antibodies against Pseudomonas," Univax said. The firm plans eventually to submit simultaneous PLAs for the vaccine, as used to elicit an immune response in donors, and for the IVIG treatment itself. "Up to 90% of CF patients eventually experience obstructive bronchitis (inflammation of the airways) associated with this bacteria," Genzyme asserted, noting that "in many of these cases, the immediate cause of death is pulmonary failure associated with Pseudomonas infection." HyperGAM+ CF has been granted an orphan designation by the FDA. Univax said that, in light of the collaboration with Genzyme, it will "very likely mutually terminate" a previous agreement with the Cystic Fibrosis Foundation under which the foundation partially funded development of HyperGAM+ CF. The Univax/Genzyme agreement extends to 10 years after the commercialization date of HyperGAM+ CF, at which time it is renewable.

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