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    [{"orgOrder":0,"company":"Medac","sponsor":"Fresenius Kabi AG","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Fresenius Kabi Enters Marketing Agreement For Biosimilar Product","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Medac","sponsor":"Medexus Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Medexus and Medac Enter Into a License Agreement for Treosulfan, in the United States","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Medac","sponsor":"Medexus Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Medexus Pharmaceuticals and medac GmbH enter into Licensing Agreement for First-in-Class Conditioning Agent, Treosulfan, in Canada","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Medac","sponsor":"Medexus Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Treosulfan Pivotal Study Results Published","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Medac","sponsor":"Byondis","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Medac","sponsor":"Glycostem Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Glycostem and Medac Enter Into License, Manufacturing, Supply and Commercialization Agreement for Glycostem's Lead Product - oNKord","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"GERMANY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Medac","sponsor":"Eisai","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Metoject\u00ae Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Medac","sponsor":"UroGen Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Nippon Medac","sponsor":"Eisai","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Metoject\u00ae Subcutaneous Injection Pen (methotrexate) Pen-Type Autoinjector Approved in Japan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]

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              Nippon Medac

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              Metoject® Subcutaneous Injection Pen (methotrexate) Pen-Type Autoinjector Approved in Japan

              Details:

              Metoject subcutaneous injection pen (methotrexate) works by inhibiting dihydrofolic acid reductase enzyme. It is approved for the treatment of rheumatoid arthritis.

              Lead Product(s): Methotrexate

              Therapeutic Area: Immunology Product Name: Metoject

              Highest Development Status: Approved Product Type: Small molecule

              Recipient: Eisai

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 15, 2024

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              Medac

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              UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

              Details:

              Under the agreement, UroGen will develop a next-generation novel mitomycin-based formulation, UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, for urothelial cancers.

              Lead Product(s): Mitomycin

              Therapeutic Area: Oncology Product Name: UGN-103

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: UroGen Pharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement January 17, 2024

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              Medac

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              Metoject® Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis

              Details:

              Primary endpoint of ACR20 response* at 12 weeks was 59.6% in Metoject (Methotrexate) group versus 51.0% in oral MTX group, indicating comparable efficacy. Adverse drug reaction incidence rates in this trial were 25.0% in the Metoject group and 34.0% in the oral MTX group.

              Lead Product(s): Methotrexate

              Therapeutic Area: Immunology Product Name: Metoject

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Eisai

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 26, 2022

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              Medac

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              Glycostem and Medac Enter Into License, Manufacturing, Supply and Commercialization Agreement for Glycostem's Lead Product - oNKord

              Details:

              Under the terms of the agreement, medac receives an exclusive license to commercialize oNKord® (GTA002) in the EU, the UK and further European countries for acute myeloid leukemia (AML) and multiple myeloma (MM) patients.

              Lead Product(s): GTA002,Cyclophosphamide,Fludarabine Phosphate

              Therapeutic Area: Oncology Product Name: oNKord

              Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

              Recipient: Glycostem Therapeutics

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement August 01, 2022

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              Medac

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              EMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer

              Details:

              Antibody part of SYD985 (trastuzumab duocarmazine) binds to HER2 on surface of cancer cell and the ADC is internalized by cell. After proteolytic cleavage of linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death.

              Lead Product(s): (vic-) Trastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              Highest Development Status: Phase III Product Type: Large molecule

              Recipient: Byondis

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 18, 2022

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              Medac

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              Treosulfan Pivotal Study Results Published

              Details:

              Study found event-free survival and overall survival superior after Trecondyv (treosulfan) compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm.

              Lead Product(s): Treosulfan,Fludarabine Phosphate

              Therapeutic Area: Oncology Product Name: Trecondyv

              Highest Development Status: Approved Product Type: Small molecule

              Recipient: Medexus Pharmaceuticals

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 06, 2022

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              Medexus Pharmaceuticals and medac GmbH enter into Licensing Agreement for First-in-Class Conditioning Agent, Treosulfan, in Canada

              Details:

              Treosulfan will be marketed in Canada under the brand name Trecondyv® and indicated in combination with fludarabine as part of a conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (“allo-HSCT”).

              Lead Product(s): Treosulfan,Fludarabine Phosphate

              Therapeutic Area: Oncology Product Name: Trecondyv

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Medexus Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement July 12, 2021

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              Medexus and Medac Enter Into a License Agreement for Treosulfan, in the United States

              Details:

              Medac intends to leverage its strong, existing commercial infrastructure in the United States to address the underserved allo-HSCT market through its commercialization of treosulfan.

              Lead Product(s): Treosulfan,Fludarabine Phosphate

              Therapeutic Area: Oncology Product Name: Trecondi

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Medexus Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement February 02, 2021

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              Fresenius Kabi Enters Marketing Agreement For Biosimilar Product

              Details:

              Medac’s sales representatives will begin offering the adalimumab biosimilar IDACIO® as an additional therapy option to the rheumatologists and dermatologists they work with.

              Lead Product(s): Adalimumab

              Therapeutic Area: Immunology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Fresenius Kabi AG

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement May 28, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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