Univax, Genzyme link up on cystic fibrosis therapy Mass. firm to underwrite clinical trials


Univax Biologics Inc., a Rockville-based biotechnology company, said yesterday that it has formed a partnership with Genzyme Corp. under which Genzyme will underwrite most of the costs of clinical trials to test a possible treatment for a respiratory infection that kills 95 percent of cystic fibrosis patients.

Genzyme, based in Cambridge, Mass., will invest $5 million in Univax stock and will provide $6 million in payments to the Maryland company in return for marketing rights to HyperGAM+CF, a therapy for fighting the pseudomonas bacteria.

Pseudomonas, which is harmless to the lungs of most people, causes a deadly inflammation of the airways of patients with cystic fibrosis, a genetic defect that leaves them unable to produce the antibody that kills the bacteria. The median life expectancy for the estimated 30,000 Americans with cystic fibrosis is 29 years.

The therapy, developed at Brigham & Woman's Hospital in Cambridge, Mass., is not regarded as a potential cure for cystic fibrosis, said Dr. Robert Beall, executive vice president for medical affairs at the Cystic Fibrosis Foundation in Bethesda.

However, Dr. Beall said it is a promising therapy that could improve the life expectancy and quality of life for people with the disease.

"There's enough of a glimpse of optimism," he said. "We've got a lot of physicians who would like to participate in the clinical trial."

Cabot Caskie, Univax's chief financial officer, said HyperGAM+CF has already completed its preclinical trials, which showed the therapy to be effective against pseudomonas in the test tube, and the first phase of clinical trials, which demonstrate a drug's safety.

Genzyme's cash will allow Univax, a 5-year-old company that does not yet have products on the market, to cover the estimated $11 million cost of the final phases of clinical trials, which determine the dosage and test the efficacy of a drug. If the trials are successful, Univax would manufacture the drug and the companies would share revenues.

Even if the clinical trials go well, HyperGAM+CF will not be on the market soon, Mr. Caskie said. The trials take up to 16 months, and Food and Drug Administration approval will take at least six months, he said.

Mr. Caskie said HyperGAM+CF will be prepared by inoculating healthy blood plasma donors with a vaccine that will stimulate the production of pseudomonas antibodies. The antibodies will then be extracted from the donors' plasma and administered to cystic fibrosis patients.

Genzyme, with $219.1 million in sales last year, is a biopharmaceutical company that is also developing therapies for cystic fibrosis.

Univax had $51 million in 1992 revenues, all from companies with which it is collaborating.

Univax stock closed yesterday at $8.125, down 12.5 cents.

Genzyme stock dropped $1.50 to $29.

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