Jazz Pharmaceuticals inked an agreement with Sigma-Tau Pharmaceuticals under which a Jazz subsidiary will pick up the rights to defibrotide in the U.S. and all other countries in the Americas. Sigma-Tau currently holds the rights to market defibrotide in the Americas under an agreement with Gentium, which Jazz acquired in December.
Sigma-Tau will be getting an upfront payment of $75 million and could also get milestone payments of $25 million if the FDA accepts the filing of the first NDA for defibrotide for severe hepatic veno-occlusive disease (VOD) and up to an additional $150 million based on the timing of potential FDA approval of defibrotide for VOD. Jazz expects the transaction to close sometime during the third quarter of this year.
Under the name Defitelio®, Jazz is marketing defibrotide in the EU for the treatment of severe hepatic VOD in patients over one month of age undergoing hematopoietic stem cell transplantation (HSCT) therapy. Russell Cox, Jazz’ evp and COO, said in a statement that patients in the U.S. with severe VOD have a critical unmet medical need that defibrotide has the potential to fill.
“The acquisition of the remaining worldwide rights to defibrotide is a strong strategic fit with our specialty focus and would continue the momentum of our recent launch of Defitelio in the EU, further leveraging our global clinical and commercial expertise in hematology/oncology,” Jazz' chairman and CEO Bruce Cozadd added.