Seqens Seqens

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[{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Bell Potter Securities","pharmaFlowCategory":"D","amount":"$35.0 million","upfrontCash":"Undisclosed","newsHeadline":"Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Paradigm Biopharmaceuticals has Clear Path Towards Zilosul\u00ae OA Phase 3 Clinical Trial and Product Registration in Europe","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Paradigm Biopharmaceuticals Receives US FDA Feedback on IND Application for PPS in Knee OA","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Paradigm Biopharmaceuticals Initiates a Phase 3 Clinical Trial in Knee Osteoarthritis Across the U.S","therapeuticArea":"Rheumatology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Rheumatology","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MPS Clinical Program Update and Paradigm to Present at the International Conference on Lysosomal Diseases","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Paradigm Achieves Primary Endpoint in PARA_OA_008 Synovial Fluid Biomarker Phase 2 Clinical Trial","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Paradigm Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Australia's Paradigm Biopharmaceuticals Says Phase 2 Trial in Osteoarthritis Shows Signs of Disease Modification at 6-Month Follow-Up","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"}]

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            Details:

            Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects. Clinical study has demonstrated that iPPS may slow the progression of osteoarthritis of the knee.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 11, 2023

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            Details:

            Pentosan Polysulfate Sodium (under the name Zilosul®) is used to treat osteoarthritis. iPPS impacted multiple biomarkers measured in the synovial fluid. Reductions in nerve growth factor (NGF) indicate iPPS mechanisms related to pain reduction.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Zilosul

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 04, 2022

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            Details:

            Three of the four subjects included in Paradigm's open-label phase 2 trial of pentosan polysulfate sodium (PPS) in MPS-I have completed the 48-week study, with a 6-month treatment extension available.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 12, 2022

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            Details:

            Zilosul (pentosan polysulfate sodium (PPS) is a semi-synthetic drug manufactured from European beech xylans that are sulfated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Zilosul

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 12, 2022

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            Details:

            The purpose of the study is to measure the change in pain and function with subcutaneous injections of Zilosul (Pentosan Polysulfate Sodium) compared with subcutaneous injections of placebo in participants with kOA pain.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Rheumatology Product Name: Zilosul

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 17, 2022

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            Details:

            In parallel, Paradigm is continuing Phase 3 study start-up preparation at sites in the US and Australia. Additional sites may be added in order to ensure completion of this pivotal study, within the planned commercialisation timelines.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Zilosul

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 25, 2021

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            Details:

            Positive feedback has been received from European Medicines Agency after Paradigm’s recent Scientific Advice meeting, a key regulatory milestone which supports and validates the company’s clinical development and commercialisation plans for Zilosul® in Europe.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Zilosul

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2020

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            Details:

            Proceeds will be applied to costs of the second phase 3 osteoarthritis (OA) clinical trial and leaves Paradigm fully-funded through to completion of this trial.

            Lead Product(s): Pentosan Polysulfate Sodium

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bell Potter Securities

            Deal Size: $35.0 million Upfront Cash: Undisclosed

            Deal Type: Financing April 20, 2020

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