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Protalix BioTherapeutics
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Elfabrio (pegunigalsidase alfa-iwxj) is a PEGylated enzyme replacement therapy (ERT) for the treatment of adult patients with Fabry disease. It is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life.


Lead Product(s): Pegunigalsidase alfa-iwxj

Therapeutic Area: Genetic Disease Product Name: Elfabrio

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 10, 2023

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PRX-102 (pegunigalsidase alfa), EC authorized, is a novel PEGylated, covalently crosslinked form of α-galactosidase-A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 05, 2023

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PRX-115 is a PEGylated enzyme expressed via ProCellEx® for intravenous (IV) administration of recombinant Uricase, designed for safe and efficacious treatment of refractory gout


Lead Product(s): PRX-115

Therapeutic Area: Rheumatology Product Name: PRX-115

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 21, 2023

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Details:

PRX–102 (pegunigalsidase alfa) a novel PEGylated, covalently crosslinked form of α-galactosidase A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX–102

Highest Development Status: Phase IIIProduct Type: Large molecule

Recipient: Chiesi Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2023

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Details:

PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. It is a novel, PEGylated ERT under development for the treatment of Fabry disease.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 05, 2022

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Details:

PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX–102

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 14, 2022

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Results from the clinical development programme developed with Protalix BioTherapeutics evaluating pegunigalsidase alfa (PRX-102) an investigational enzyme replacement therapy (ERT), support its potential as a treatment option for adult patients with Fabry disease.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase IIIProduct Type: Large molecule

Recipient: Chiesi Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 02, 2022

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Details:

Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 11, 2021

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PRX–102 is currently being studied in the pivotal Phase III BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX–102 for the proposed treatment of Fabry disease.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2021

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Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch.


Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX–102

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 10, 2021

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