Yugoslavia Allows Sale of SPI’s Virazole

Yugoslav health officials have given approval for SPI Pharmaceutical Inc.’s Belgrade subsidiary to market its patented antiviral drug, Virazole, for injection treatment of a deadly fever, the company said Wednesday.

Yugoslavia is the first European nation to authorize use of Virazole to treat hemorrhagic fever associated with Renal Syndrome. The disease is characterized by severe shock, internal bleeding and kidney failure and is caused by the Hantaan virus.

China, where about 300,000 cases of Renal Syndrome are diagnosed each year and the mortality rate is 20%, in 1990 approved the use of Virazole in combatting the disease.

To date, the drug has not been sold in China, but SPI is currently negotiating to form a joint venture to manufacture and distribute the drug there, said company spokesman Paul Knopick.

In Yugoslavia, 15 people have died so far since the 1989 outbreak of the highly contagious disease. The drug will be marketed in Yugoslavia by SPI’s subsidiary, ICN Galenika, which was purchased in May from the national government.

In the United States, Virazole, generically called ribavirin, is approved only for treatment of respiratory syncytial virus, or RSV, which infects the respiratory tracts of infants and children younger than 4 years old.