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[{"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":"Small molecule","graph2":"Paradigm Biopharmaceuticals"},{"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":"Small molecule","graph2":"Paradigm Biopharmaceuticals"},{"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":"Small molecule","graph2":"Paradigm Biopharmaceuticals"},{"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":"Small molecule","graph2":"Paradigm Biopharmaceuticals"}]

Paradigm Biopharmaceuticals

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FDA Grants Fast Track Designation for Paradigm Biopharmaceuticals Phase III Osteoarthritis Program

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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Paradigm Biopharmaceuticals

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Paradigm Biopharmaceuticals Receives US FDA Feedback on IND Application for PPS in Knee OA

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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Paradigm Biopharmaceuticals has Clear Path Towards Zilosul® OA Phase 3 Clinical Trial and Product Registration in Europe

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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Paradigm Biopharmaceuticals

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Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol

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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