Jazz Pharma gains Americas rights to defibrotide from Sigma-Tau
Ireland-headquartered drugmaker Jazz Pharmaceuticals (Nasdaq: JAZZ) has signed a definitive agreement Pharmaceuticals with privately-held Italian drugmaker Sigma-Tau for rights to defibrotide in the USA and all other countries in the Americas.
Sigma-Tau holds rights to market defibrotide in the Americas under an agreement with Italy’s Gentium, which was acquired by Jazz last year for $1 billion.
Defibrotide is a novel product that is marketed by Jazz in the European Union 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 USA, Jazz is working with the Food and Drug Administration on the regulatory pathway for submission of a New Drug Application for the potential approval of defibrotide to treat patients with severe VOD.
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