Biotest Pharmaceuticals Responds to Orphan Drug Act Announcement
Published: Mar 27, 2008
BOCA RATON, Fla., March 27 /PRNewswire/ -- Biotest Pharmaceuticals Corporation, a leading developer of immunology biotherapeutic products, today responded to an announcement that a Hepatitis B Immune Globulin Intravenous (Human) product manufactured by another company has received Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of hepatitis B recurrence following orthotopic liver transplantation.
"The designation announced yesterday does not affect our ability to continue to provide Nabi-HB(R) 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," said Dr. Rainer Pabst, Chief Executive Officer of Biotest Pharmaceuticals.
Biotest Pharmaceuticals acquired Nabi-HB as part of the company's acquisition of Nabi Biopharmaceuticals' Biologics Strategic Business Unit in December 2007.
About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation develops and manufactures pharmaceutical and biotherapeutic products with a specialization in immunology. Biotest Pharmaceuticals will offer the hyperimmunoglobulin Nabi- HB(R), a key product used in the prevention of hepatitis B. Biotest Pharmaceuticals also is currently working to develop additional products including a polyvalent immunoglobulin (IVIG, Phase III) and Civacir(R) (Phase IIb), for the prevention of hepatitis C in liver transplant patients. Biotest Pharmaceuticals was formed in 2007 as part of the Biotest AG acquisition of Nabi Biopharmaceuticals' Biologics business unit, including its plasmapheresis centers across the United States. The company employs approximately 500 people in the U.S. Biotest Pharmaceuticals is a subsidiary of Biotest AG, a German- based global provider of plasma proteins that employs approximately 1,750 people worldwide.
CONTACT: Keri P. Mattox of ThreeZero Communications, +1-215-791-0105,
Web site: http://www.biotestpharma.com/