Suanfarma Suanfarma

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[{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai\u2019s Equfina receives South Korean marketing approval to treat Parkinson\u2019s disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Meiji Seika Pharma","sponsor":"Eisai","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Eisai to Take Over Manufacturing and Marketing Approval for Equfina\u00ae 50 Mg Tablets (safinamide Mesilate)INn Japan from Meiji Seika Pharma","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Zambon Switzerland","sponsor":"Newron Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Newron and Zambon Sign Agreement for Potentially Pivotal Study with Safinamide in Parkinson\u2019s Disease Patient","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Zambon Group SpA","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Plans scrapped for Xadago Trial for Levodopa-induced Dyskinesia","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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            Details:

            Under the agreement, Newron and Zambon have ended their plans to run a clinical trial to test Xadago (safinamide) for uncontrolled movements induced by levodopa in people with Parkinson’s disease.

            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Xadago

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Zambon Group SpA

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 15, 2023

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            Under the agreement, Newron will sponsor the study and be responsible for Xadago (safinamide), development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.

            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Xadago

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Newron Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 12, 2021

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            Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.

            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Equfina

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Eisai

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 07, 2020

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            The marketing authorization application for safinamide in South Korea was submitted in July 2019, and through the approval of this application, South Korea became the first country in Asia outside of Japan to grant marketing approval for safinamide.

            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Equfina

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 25, 2020

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