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Nabi acquires U.S., Canadian commercialization rights to Fresenius' antibody product
New York, April 3 - Nabi Biopharmaceuticals said it has acquired the rights to sell and distribute ATG-Fresenius S in the United States and Canada.
ATG-Fresenius S is an immunosuppressive polyclonal antibody product used for the prevention and treatment of acute rejection following organ transplantation.
Under the license with Fresenius Biotech GmbH, Nabi's rights will run for up to 15 years following the first commercial sale of the product after licensing in the United States.
Nabi will make $1 million in milestone payments during development and a further $4 million on approval by the Food and Drug Administration.
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 United States and Canada.
ATG-Fresenius S for lung transplantation was given fast track status by the FDA in January 2005.
As art of the new agreement, Nabi will assume oversight of a phase 3 clinical trial currently underway in the United States and Europe. Nabi may also undertake additional studies to expand the indications into other areas, such as bone marrow transplantation.
"This agreement represents an exciting opportunity for Nabi Biopharmaceuticals to leverage our proven strengths in marketing specialized antibody products to commercialize a drug that has been used in the treatment of more than 150,000 transplant patients around the world," said Thomas H. McLain, chairman, chief executive officer and president of Nabi Biopharmaceuticals, in a news release.
Nabi is a Boca Raton, Fla., biotechnology company.
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