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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: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Eton Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition October 04, 2023

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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: ApprovedProduct 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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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 IIIProduct 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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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: ApprovedProduct 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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