Jazz Pharmaceuticals Completes Acquisition of Rights to Defibrotide in the Americas from Sigma-Tau Pharmaceuticals, Inc.

Jazz Pharmaceuticals plc has announced the closing of its acquisition of rights to defibrotide in the US and all other countries in the Americas from Sigma-Tau Pharmaceuticals, In. Jazz Pharmaceuticals now owns worldwide rights to defibrotide.

Defibrotide is a novel product that is marketed by Jazz Pharmaceuticals in the 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 US, Jazz Pharmaceuticals is working with 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 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.