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news.Ireland-based Jazz Pharmaceuticals has completed the acquisition of rights to defibrotide in the US and all other countries in the Americas from Sigma-Tau Pharmaceuticals (Sigma-Tau).
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In the European Union (EU), defibrotide is marketed by Jazz Pharmaceuticals 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.
Jazz is working with the US 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.
As part of the previously-announced agreement, defibrotide was acquired for an upfront payment of $75m plus potential milestone payments of $25m upon the acceptance for filing by the FDA of the first NDA for the drug to treat VOD and up to an additional $150m based on the timing of potential FDA approval of defibrotide for VOD.
Jazz Pharmaceuticals has a diverse portfolio of products and product candidates in the areas of sleep, hematology/oncology, pain and psychiatry.
In the US, products marketed by the company in these areas include Xyrem oral solution, Erwinaze, Prialt intrathecal infusion, Versacloz oral suspension, FazaClo HD and FazaClo LD.
Image: Defibrotide is marketed by Jazz Pharmaceuticals under the name Defitelio for the treatment of VOD in the EU. Photo: courtesy of Baitong333/ freedigitalphotos.net