Jazz Pharmaceuticals, announced the closing of its acquisition of rights to defibrotide in the United States (US) and all other countries in the Americas from Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Jazz Pharmaceuticals now owns worldwide rights to defibrotide.
Defibrotide is a novel product that is marketed by Jazz Pharmaceuticals in the European Union (EU) under the name Defitelio for the treatment of severe hepatic veno-occlusive disease (VOD) in patients over one month of age undergoing hematopoietic stem cell transplantation (HSCT) therapy. In the U.S., Jazz Pharmaceuticals is working with the Food and Drug Administration (FDA) on the regulatory pathway for submission of a New Drug Application (NDA) for the potential approval of defibrotide to treat patients with severe VOD.
Under the previously-announced definitive agreement with Sigma-Tau, a wholly-owned subsidiary of Jazz Pharmaceuticals acquired the rights to defibrotide in the Americas for an upfront payment of $75 million plus potential milestone payments of $25 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD and up to an additional $150 million based on the timing of potential FDA approval of defibrotide for VOD.