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March 30, 2017

Nippon Shinyaku enters into license agreements with Jazz Pharmaceuticals plc for Defitelio® and Vyxeos™

Nippon Shinyaku Co., Ltd (HQ: Kyoto, President: Shigenobu Maekawa) and Jazz Pharmaceuticals plc (HQ: Dublin, Ireland, Chairman & CEO: Bruce C. Cozadd) announced that the two companies have signed license agreements on Defitelio® (defibrotide sodium) injection, for intravenous use, approved in the U.S. and Europe for the treatment of hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT), and Vyxeos (cytarabine and daunorubicin liposome injection, CPX-351) for the treatment of high risk acute myeloid leukemia (AML). The agreements enable Nippon Shinyaku to exclusively develop and commercialize the two products in Japan.

Defitelio® is the first approved therapy for the treatment of severe hepatic VOD, a rare and life-threatening liver condition which develops in patients following HSCT. Defitelio® was approved by the European Medicines Agency (EMA) in 2013 and by the U.S. Food and Drug Administration (FDA) in 2016. Defitelio® has been launched in 31 countries including 28 European countries, the U.S., Israel, and Korea.

Vyxeos (CPX-351) is a liposomal combination of the antineoplastic agents cytarabine and daunorubicin, the standard treatments of AML. The product is the first therapy that has demonstrated statistically significant improvement in overall survival of high risk AML patients compared with the current standard therapy of cytarabine and daunorubicin (e.g. 7+3). The FDA has granted Breakthrough Therapy designation in May, 2016 to CPX-351 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes.

Nippon Shinyaku markets the products for a variety of haematological malignancies such as Vidaza® for myelodysplastic syndrome, Amnolake® and Trisenox® for relapsed/refractory acute promyelocytic leukemia, and Cylocide® N injection for relapsed/refractory acute leukemia and malignant lymphoma.

Defitelio® and Vyxeos (CPX-351) have been developed to fulfil serious and unmet medical needs in the treatment of diseases/disorders in the fields of haematological malignancies. Nippon Shinyaku aims to contribute to improving treatment options for patients with VOD and AML by working to obtain marketing authorization for Defitelio® and Vyxeos in Japan as soon as possible.



About VOD

Veno-occlusive disease (VOD) occurs when the small blood vessels that lead into or are inside the liver become blocked. Chemotherapy and radiation therapy given during conditioning or intensive therapy before stem cell transplantation can increase the risk of developing VOD. Features of VOD include weight gain, tender hepatomegaly, ascites, and jaundice. In severe cases, VOD can cause multi-organ dysfunction or failure, leading to death in up to 80% of patients.

ABOUT JAZZ PHARMACEUTICALS PLC

Jazz Pharmaceuticals plc, established in 2003, is an international biopharmaceutical company with headquarters in Dublin, Ireland. The company is focused on the development and commercialization of products that address debilitating and life-threatening conditions with a focus in the fields of sleep and hematology/oncology. Jazz Pharmaceuticals markets mainly Xyrem® (sodium oybate) oral solution for the treatment of narcolepsy, Erwinaze® (asparaginase Erwinia chrysanthemi) for acute lymphoblastic leukemia, and Defitelio® (defibrotide sodium) for the treatment of patients with VOD with renal or pulmonary dysfunction following HSCT.

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