Nabi Biopharmaceuticals announced 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 US 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 McLain, CEO.

Chronic hepatitis B virus (HBV) infection is a frequent cause of end-stage liver disease and is present in approximately 5 per cent 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 US 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.