Nabi Biopharmaceuticals has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the use of Nabi-HB Intravenous, Hepatitis B Immune Globulin (Human), to prevent liver transplant patients from suffering re-infection of their transplanted livers with hepatitis B virus (HBV).

"The filing of this BLA represents a significant milestone for our company," stated David J. Gury, chairman and chief executive officer. "If the Nabi-HB Intravenous BLA is ultimately approved, it would represent the first hepatitis B immune globulin therapy approved by the FDA to help protect patients from HBV re-infection following liver transplant surgery. Hepatitis B continues to be a major global medical problem and this BLA filing demonstrates our commitment to help address serious unmet medical needs. Underscoring the product's significance for this patient population, Nabi-HB Intravenous has received Orphan Drug Designation for its use in liver transplant patients."

Nabi-HB is a sterile solution of human antibodies that has been approved by FDA for preventing infection with HBV upon acute exposure. The product is produced at the Nabi Biopharmaceuticals' manufacturing plant in Boca Raton, Florida.

Hepatitis B is the most severe form of viral hepatitis and a leading cause of liver cancer. Infection with hepatitis B virus (HBV) often leads to chronic disease. One hundred times more infectious than the AIDS virus, it is a leading cause of death worldwide. It is estimated that more than 350 million people worldwide are chronically infected with HBV, one-third of whom are expected to develop serious liver disease and approximately 1 million will die each year. An estimated 1.25 million Americans are chronically infected with HBV, with 20 to 30 percent acquiring their infections in childhood, according to the U.S. Centers for Disease Control and Prevention.