BOCA RATON, Fla. -- Nabi Biopharmaceuticals announces that it has signed an international
distribution agreement for Nabi-HB [Hepatitis B Immune Globulin (Human)]
with Kamada Ltd., a global biopharmaceutical company engaged in the
development, production and marketing of specialty plasma products. Under the
terms of the agreement, Kamada will purchase finished Nabi-HB from Nabi and
will coordinate the regulatory approval process for registration of the
product with several countries, including the state of Israel and administered
territories, Argentina, Brazil, Mexico and India. Once approved, Kamada will
exclusively sell and distribute Nabi-HB within these countries.
"We believe that the future growth of Nabi-HB sales outside the United
States will be in intravenous use to prevent re-infection of hepatitis B
disease in HBV-positive liver transplant patients. This agreement marks a
critical milestone in our global commercialization strategy to address this
underserved and growing international health concern," said Thomas H. McLain,
chief executive officer and president.
Chronic hepatitis B virus (HBV) infection is a frequent cause of end-stage
liver disease and is present in approximately 5 percent of liver transplant patients.
During liver transplant surgery and in the period immediately following
surgery, patients do not have other licensed treatment options to prevent re-
infection of the new liver. Re-infection of the transplanted liver in HBV-
positive patients almost always occurs after surgery.
A Biologics License Application (BLA) for an intravenous formulation of
Nabi-HB to prevent hepatitis B disease in HBV-positive liver transplant
patients has been submitted to the FDA for approval, and the company expects a
response during the first half of this year. In Europe, Nabi plans to submit
its first license application for the intravenous formulation in the first
half of 2004. Nabi then plans to seek additional regulatory approval to
commercialize Nabi-HB in certain other European countries using the mutual
recognition process. Nabi also plans to enter into agreements with additional
distributors to help grow its business in markets outside the U.S. and Europe.
Nabi-HB is a sterile solution of human antibodies that is manufactured at
Nabi Biopharmaceuticals' FDA-licensed manufacturing facility in Boca Raton,
Florida. It is currently approved in the U.S. for prevention of hepatitis B
virus (HBV) infection following acute exposure.
HBV is a major global health concern. According to the
World Health Organization, of the 2 billion people who have been infected with
HBV, more than 350 million have chronic (lifelong) infections. These
chronically infected persons are at high risk of death from cirrhosis of the
liver and liver cancer, diseases that kill about one million persons each
year. The U.S. Centers for Disease Control, or CDC, currently estimates that
in the U.S. alone there are approximately 1.2 million chronic hepatitis B
carriers, 8,500 new hepatitis B infections per year and 5,000 individuals who
die annually from hepatitis B or its complications. Chronic HBV infection
usually results in liver disease which can lead to liver failure and the need
for transplantation. Recurrence of HBV infection following liver transplant
is almost universal if left untreated.
Source: Nabi Biopharmaceuticals