Jazz Pharmaceuticals plc, a specialty biopharmaceutical company headquartered in Dublin, Ireland, has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. under which a subsidiary of Jazz Pharmaceuticals will acquire from Sigma-Tau rights to defibrotide in the United States 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 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 therapy. In the US, Jazz is working with the Food and Drug Administration (FDA) on the regulatory pathway for submission of a new drug application for the potential approval of defibrotide to treat patients with severe VOD.

As part of the agreement, Sigma-Tau would receive an upfront payment of $75 million upon closing of the transaction. Sigma-Tau would be eligible to receive milestone payments of $25 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD and up to an additional $150 million based on the timing of potential FDA approval of defibrotide for VOD. Jazz expects to fund the transaction with cash on hand and that the transaction will close during the third quarter of 2014, subject to customary closing conditions.

Source: Jazz Pharmaceuticals