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giovedì 22 Aprile 2021

Menarini Group and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize ELZONRIS® (Tagraxofusp) in Japan

Da leggere

– Menarini advances the global roll out of Elzonris and underscores its commitment to delivering innovative medicines around the world 

– Partnership with Nippon Shinyaku allows Menarini to start building a footprint in Japan 

FLORENCE, Italy, March 29, 2021 /PRNewswire/ — The Menarini Group announced today that it has entered into an exclusive license agreement for the development and commercialization of ELZONRIS® (tagraxofusp) in the territory of Japan with Nippon Shinyaku Co., Ltd. ELZONRIS is approved for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) by the U.S. Food and Drug Administration and the European Medicines Agency. 


BPDCN is a rare, aggressive hematologic malignancy with historically poor outcomes. ELZONRIS (tagraxofusp) is the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in both the United States and Europe.  

“Partnering with Nippon Shinyaku marks another important step forward in our effort to meet the needs of patients with difficult-to-treat diseases and underscores our commitment to delivering innovative medicines for people around the globe,” commented Elcin Barker Ergun, CEO of the Menarini Group. “Patients with BPDCN have limited treatment options and we are excited to be collaborating closely with Nippon Shinyaku to make ELZONRIS (tagraxofusp) available to patients in Japan.” 

About ELZONRIS® in the European Union 

ELZONRIS® (tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. 

About ELZONRIS® in the USA 

ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with BPDCN. For full prescribing information in the U.S., visit www.ELZONRIS.com. 

ELZONRIS is also being evaluated in additional clinical trials in other indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others are planned. 

About BPDCN 

BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Organization (WHO) termed this disease “BPDCN” in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com. 

About CD123 

CD123 is a cell surface target expressed on a wide range of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123+ cells have been detected in the tumor microenvironment of several solid tumors as well as in certain autoimmune disorders including cutaneous lupus and scleroderma. 

Important Safety Information from EU SmPC 

Warnings and precautions 

Summary of the Safety Profile  

For full prescribing information in Europe please refer to the full SmPC at https://www.ema.europa.eu

About the Menarini Group 

Menarini Group is a leading international pharmaceutical company with a presence in 140 countries, including a direct presence in over 70 countries. Its global platform extends throughout Europe, U.S., Central America, Africa, the Middle East and Asia Pacific, and generates over $4.2 billion in annual sales. Menarini is committed to oncology, with an already commercialized product in the US and several new investigational drugs in development for the treatment of a variety of tumors. For over 130 years, Menarini has also been investing in the development, production and distribution of pharmaceuticals to serve patients and physicians around the world with a full portfolio of products covering a number of different therapeutic areas. 

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