On March 30, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it has entered into license agreements with Nippon Shinyaku, Co., Ltd. for Defitelio (defibrotide sodium) and Vyxeos (cytarabine and daunorubicin liposome injection), or CPX-351, in Japan (Press release, Jazz Pharmaceuticals, MAR 30, 2017, View Source [SID1234518312]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreements, Nippon Shinyaku will receive exclusive rights to develop and commercialize Defitelio and Vyxeos in Japan in return for an upfront payment to Jazz Pharmaceuticals and subsequent payments based on the successful achievement of certain regulatory and commercial milestones. Jazz Pharmaceuticals will manufacture and supply Defitelio and Vyxeos to Nippon Shinyaku, and will receive revenue based on a percentage of product sales in Japan. Financial terms of the agreement have not been disclosed. Commercialization of Defitelio and Vyxeos in Japan is subject to regulatory approval in Japan.
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"We are pleased to have Nippon Shinyaku as our strategic partner in Japan," said Iain McGill, senior vice president, Jazz Pharmaceuticals Europe and rest of world. "Nippon Shinyaku’s expertise and focus in hematology/oncology make them an outstanding partner to bring Defitelio and Vyxeos to patients with significant unmet medical needs in Japan."
About Defitelio
Defitelio received marketing approval in the U.S. in 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). In 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. HSCT is an aggressive, potentially curative procedure to treat patients with malignant and non-cancerous hematologic disorders such as leukemia, lymphoma and aplastic anemia, and congenital immunodeficiency and autoimmune disorders. VOD is a rare and potentially life-threatening complication of HSCT affecting the sinusoidal endothelial cells of the liver, which occurs in approximately 9-14% of HSCT patients.1,2 Defibrotide is also being investigated in a global Phase 3 randomized study (NCT02851407) for the prevention of hepatic VOD in high risk adult and pediatric patients undergoing HSCT. Defibrotide is currently an investigational drug in Japan and the Defitelio trade name has not been approved.
About Vyxeos (CPX-351)
Vyxeos, or CPX-351, is an investigational product being evaluated for the treatment of AML and is a combination of the antineoplastic agents cytarabine and daunorubicin encapsulated within a nano-scale liposome at a 5:1 molar ratio. The proposed trade name, Vyxeos, is conditionally approved by the U.S. Food and Drug Administration (FDA) and is subject to confirmation upon approval of the New Drug Application (NDA). Data from the pivotal Phase 3 study, which met its primary endpoint, were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2016. Jazz Pharmaceuticals has initiated a rolling NDA submission to the FDA with expected completion of the submission by the end of March 2017. A Marketing Authorization Application to the European Medicines Agency is planned for the second half of 2017. There have been no studies with CPX-351 in Japan, and the Vyxeos trade name has not been approved.