Cangene gets orphan status for HepaGam

Canada's Cangene Corp says that its HepaGam B (hepatitis B immune globulin intravenous [human]), has received orphan drug exclusive approval from the US Food and Drug Administration for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen-positive liver transplant patients.

Biotest responds

Responding to the news, US firm Biotest Pharmaceuticals' chief executive, Rainer Pabst, noted that "the designation...does not affect our ability to continue to provide Nabi-HB to the marketplace. Nabi-HB has been the industry gold standard for the prevention of hepatitis B infection following accidental exposure to hepatitis B virus and many hospitals, physicians and patients have come to rely on Nabi-HB's long, safe and effective history since its approval in the late 1990s. We are committed to continuing to work with our partners and the medical and patient community to provide Nabi-HB to those who need it. Biotest Pharmaceuticals also is committed to continuing our research and development activities in the hepatitis liver transplant community."