Dive Brief:
- Jazz has acquired rights to defibrotide in the Americas. The company already has rights in Europe where the drug has been marketed as Defitelio since EMA approval in October 2013.
- Defibrotide is for treatment of severe hepatic veno-occlusive disease in patients over month of age who are undergoing hematopoietic stem cell transplantation therapy.
- Total payments from Jazz to Sigma-Tau, including an upfront payment and milestone payments, are $250 million.
Dive Insight:
Jazz has acquired rights to the defibrotide NDA and is now engaged in the hard work of gaining FDA approval for treatment of VOD infections in HSCT patients.
Payments include $75 million up front, $25 million for acceptance from FDA to file the NDA and an additional $150 million upon FDA approval -- depending on timing. Jazz will fund all payouts from cash on hand.