Jazz Pharma acquires US rights to Defitelio in US from Sigma Tau Pharma.

Jazz Pharmaceuticals plc has announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. under which a subsidiary of Jazz Pharmaceuticals plc will acquire from Sigma-Tau rights to defibrotide in the United States (U.S.) and all other countries in the Americas. Sigma-Tau holds rights to market defibrotide in the Americas under an agreement with Gentium S.p.A., which was acquired by Jazz earlier this year.

Defibrotide is a novel product that is marketed by Jazz in the European Union (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 U.S., Jazz is working with the 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.