Date: 2014-07-02
Type of information: Licensing agreement
Compound: Defitelio® (defibrotide)
Company: Jazz Pharmaceuticals (Ireland) Sigma-Tau Pharmaceuticals (USA - MD)
Therapeutic area: Rare diseases
Type agreement: licensing
Action mechanism:
Disease: hepatic veno-occlusive disease
Details: * On July 2, 2014, Jazz Pharmaceuticals announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals, 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, which was acquired by Jazz earlier this year. Defibrotide 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. \"The acquisition of the remaining worldwide rights to defibrotide is a strong strategic fit with our specialty focus and would continue the momentum of our recent launch of Defitelio in the EU, further leveraging our global clinical and commercial expertise in hematology/oncology,\" said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.
Financial terms: 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, including expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
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