Fresenius grants licence to market immunosuppressive agent ATG in North America

The Biotechnology Division of Fresenius and the US company Enzon Pharmaceuticals have signed an agreement regarding the development and marketing of the immunosuppressive agent ATG-Fresenius S for North America. Enzon will be granted the exclusive sales and distribution rights for ATG-Fresenius S after the product has been approved by the US authorities. The polyclonal antibody preparation is used for T-lymphocyte suppression following organ transplantations. It is currently marketed by Fresenius in over 60 countries.

Enzon will initiate a Phase III clinical programme to obtain regulatory approval for this product by the US Food and Drug Administration (FDA). Under the terms of the agreement, Enzon will be responsible for the costs related to the clinical development and registration in North America, and Fresenius for the manufacturing aspects in accordance with the requirements of the US authorities. Fresenius will receive two milestone payments of 1 million dollars each: the first payment upon approval of the IND (Investigational New Drug Application) and the second on submission of the BLA (Biological License Application). After the market launch, ENZON will purchase the product from Fresenius.

"We are very happy to have Enzon as our partner in North America. The company has proven expertise in the fields of development, regulatory approval and marketing. This co-operation opens up a wide market for our long-established, successful product", said Dr. Thomas Gottwald, Managing Director of Fresenius Biotechnology.

Arthur Higgins, Enzon's Chairman and CEO: "ATG-Fresenius S is a great strategic fit. We can utilize our development and marketing competence in this segment and enhance our product pipeline. ATG-Fresenius S has the potential to generate annual sales of more than 50 million dollars."

ATG-Fresenius S is a polyclonal antibody preparation that has proved to be extremely effective in suppressing the rejection by the immune system of organ and bone marrow transplants. The demand for ATG-Fresenius S has steadily risen over the past years, largely due to the increase in the number of bone marrow transplantations.