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Nabi Acquires Transplant Antibody in NA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Nabi Biopharmaceuticals has signed an agreement with Fresenius Biotech to advance the development of ATG-Fresenius S in the U.S. and Canada. ATG-Fresenius S is an immunosuppressive polyclonal antibody product used for the prevention and treatment of acute rejection following organ transplantation. The product, which Fresenius currently markets in more than 60 countries worldwide, has been shown to significantly reduce transplant failure and substantially improve survival rates.

Under the terms of the agreement, Fresenius Biotech has granted Nabi Biopharmaceuticals exclusive sales and distribution rights to ATG-Fresenius S in the U.S. and Canada for as many as 15 years following the first commercial sale of the product after licensure in the U.S. Nabi Biopharmaceuticals is required to make aggregate milestone payments of $1 million to Fresenius Biotech during development and a $4 million payment upon approval by the FDA. Fresenius Biotech will manufacture and supply the product from its European facility in exchange for a royalty. Nabi Biopharmaceuticals will be responsible for the clinical development, regulatory approval process, marketing and sales of ATG-Fresenius S in the U.S. and Canada.

In January 2005, the FDA granted Fast Track Status for ATG-Fresenius S in lung transplantation. As a result of the agreement, Nabi Biopharmaceuticals will assume oversight of an ongoing randomized, double-blind, placebo-controlled Phase III study that is being conducted in lung transplant patients in the U.S. and Europe. The company may also undertake additional studies to expand the indications into other areas, such as bone marrow transplantation. Based on the outcome of its upcoming meeting with the FDA, and assuming all regulatory and clinical milestones are met, Nabi Biopharmaceuticals expects to file its BLA for ATG-Fresenius S in early 2009.

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