The product is currently in phase III trials in the US for lung transplantation; however Fresenius currently markets the drug in more than 60 countries worldwide.
Nabi will pay milestone payments of $1 million to Fresenius Biotech during development and a $4 million payment upon approval by the FDA.
Under the terms of the agreement, Nabi has gained exclusive sales and distribution rights to ATG-Fresenius S in the US and Canada for up to 15 years following the first commercial sale of the product after licensure in the US.
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 US and Canada.
In January 2005, the FDA granted fast track status for ATG-Fresenius S in lung transplantation. Nabi expects to file a biologics license application for the drug in early 2009.
“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 McLain, chairman, CEO and president, Nabi Biopharmaceuticals.