FDA approves first Univax drug

March 28, 1995|By Timothy J. Mullaney | Timothy J. Mullaney,Sun Staff Writer

Univax Biologics Inc. said yesterday that it has won federal marketing approval for its first drug, a treatment for a common AIDS complication, and analysts said sales of the drug could near $100 million by 1999.

The drug could make the 7-year-old Rockville company Maryland's only profitable publicly held biotechnology/drug development company, depending on whether it can beat Genetic Therapy Inc. of Gaithersburg and Martek Biosciences Corp. of Columbia into the black.

"I think it's a very exciting step, absolutely," said Matthew Geller, an Oppenheimer & Co. analyst who added Univax's stock to the firm's list of about 145 most-recommended companies after the announcement. "It will take a while to get profitable while they ramp up, but they are one of the few biotechnology companies with an approved product."

Univax said the U.S. Food and Drug Administration licensed Rh Pharmaceuticals of Winnipeg, Canada, to manufacture WinRho SD, an intravenous immune system supplement based on proteins.

Under a 1992 agreement with Rh Pharmaceuticals, Univax has exclusive U.S. marketing rights to the drug, developed by the Canadian company, for 10 years. In exchange, Univax helped Rh Pharmaceuticals with the FDA application and will give the company a 60-40 split of the first $50 million of profits and a 50-50 split of additional profits, said Judith Hautala, Univax vice president for communications.

The product will be on the market in six to eight weeks.

Maryland officials have hoped for years that biotechnology companies would mature into a cornerstone of an economic development strategy built around life sciences. Academic and business leaders agree that life science research at Maryland facilities like Johns Hopkins Hospital and the National Institutes of Health should foster biotech growth here, but results for the 200 or so biotechnology companies in the area have been unspectacular so far.

WinRho SD has two applications. The more lucrative is using it to treat ITP, or immune thrombocytopenic purpura, an autoimmune disorder that causes the body to destroy its own platelets, thus reducing the body's ability to stop bleeding and resist bruising.

Dr. Hautala said the disease occurs in about 68,000 U.S. patients a year, including 50,000 who develop the syndrome as a complication of HIV infection. She said about 5 percent of the HIV-positive population suffers ITP complications annually.

Edward Hurwitz, an analyst with Robertson, Stephens & Co. in San Francisco, said WinRho is likely to take over a big chunk of the ITP treatment market very quickly. WinRho costs an estimated $7,000 per year per patient; competing therapies cost twice as much. And Mr. Hurwitz said WinRho can be administered in five minutes or less, compared with up to eight hours for the competition.

WinRho will also be used to treat the immune reaction common when a pregnant woman's blood has a negative Rh factor and her fetus' blood is Rh-positive. Women who are Rh-negative and have an Rh-positive child develop antibodies that attack the red blood cells of their next fetus.

The reaction, sometimes called "Blue Baby Syndrome," can damage the brain, cause jaundice in the fetus, or even cause death.

Drugs to fight the so-called Rh Baby Syndrome, known as Rh isoimmunization, have come onto the market since the 1960s, Dr. Hautala said. But the therapies posed a potential threat because they are made from plasma donated by up to thousands of people, and isolated cases had been reported of patients contracting hepatitis C or other diseases from the therapy.

WinRho SD is the first drug for the Rh baby syndrome that is "virally inactivated," a process that purifies the drug before use.

Between the two markets, Mr. Geller estimates, Univax will sell about $100 million of WinRho annually by 1999.

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