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    [{"orgOrder":0,"company":"Cycle Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Once Daily Dosing Option for NITYR (nitisinone) Tablets for HT-1 Patients","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sobi's Orfadin\u00ae (nitisinone) Receives Positive Opinion from CHMP for Treatment of AKU","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Oakrum Pharma, LLC","sponsor":"Eton Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Analog Pharma","sponsor":"Dipharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Analog Pharma and Dipharma Announce US FDA Approval of Abbreviated New Drug Application (ANDA) of 20 mg Generic Nitisinone Capsules (temperature stable)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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              Oakrum Pharma, LLC

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              Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

              Details:

              Through the acquisition, Eton gains access to an abbreviated new drug application for Nitisinone Capsules via Oakrum. Nitisinone is FDA approved or the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

              Lead Product(s): Nitisinone

              Therapeutic Area: Genetic Disease Product Name: Nitisinone-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Eton Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Acquisition October 04, 2023

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              Analog Pharma

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              Analog Pharma and Dipharma Announce US FDA Approval of Abbreviated New Drug Application (ANDA) of 20 mg Generic Nitisinone Capsules (temperature stable)

              Details:

              Orfadin (nitisinone) is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1.

              Lead Product(s): Nitisinone

              Therapeutic Area: Genetic Disease Product Name: Orfadin-Generic

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Dipharma

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 31, 2023

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              Swedish Orphan Biovitrum AB

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              Sobi's Orfadin® (nitisinone) Receives Positive Opinion from CHMP for Treatment of AKU

              Details:

              European Medicines Agency (EMA) has adopted a positive opinion for Orfadin® (nitisinone) for the treatment of adult patients with alkaptonuria (AKU). The opinion is based on the scientific results of the DevelopAKUre clinical development programme.

              Lead Product(s): Nitisinone

              Therapeutic Area: Genetic Disease Product Name: Orfadin

              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 18, 2020

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              Cycle Pharmaceuticals

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              US FDA Grants Once Daily Dosing Option for NITYR (nitisinone) Tablets for HT-1 Patients

              Details:

              NITYR® is indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

              Lead Product(s): Nitisinone

              Therapeutic Area: Genetic Disease Product Name: Nityr

              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 September 14, 2020

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              Inke S.A: APIs manufacturing plant.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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