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Farmaceutici"},{"orgOrder":0,"company":"Chiesi Group","sponsor":"Protalix BioTherapeutics","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"Pegunigalsidase alfa","moa":"Alpha-galactosidase A","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Chiesi Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Chiesi Group \/ Protalix BioTherapeutics","highestDevelopmentStatusID":"10","companyTruncated":"Chiesi Group \/ Protalix BioTherapeutics"},{"orgOrder":0,"company":"Protalix BioTherapeutics","sponsor":"Chiesi Global Rare Diseases","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ISRAEL","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"Pegunigalsidase alfa","moa":"Alpha-galactosidase A","graph1":"Genetic 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BioTherapeutics \/ Chiesi Group"},{"orgOrder":0,"company":"Chiesi Group","sponsor":"Protalix BioTherapeutics","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ITALY","productType":"Large molecule","year":"2023","type":"Not Applicable","leadProduct":"Pegunigalsidase alfa","moa":"","graph1":"Genetic Disease","graph2":"Phase III","graph3":"Chiesi Group","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Chiesi Group \/ Protalix BioTherapeutics","highestDevelopmentStatusID":"10","companyTruncated":"Chiesi Group \/ Protalix BioTherapeutics"},{"orgOrder":0,"company":"Protalix BioTherapeutics","sponsor":"Chiesi Global Rare Diseases","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"ISRAEL","productType":"Large molecule","year":"2023","type":"Not Applicable","leadProduct":"Pegunigalsidase alfa","moa":"","graph1":"Genetic 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                            01

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Approved

                            Sponsor : Chiesi Global Rare Diseases

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102...

                            Details : 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...

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            May 05, 2023

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Approved

                            Sponsor : Chiesi Global Rare Diseases

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Chiesi Group

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Protalix BioTherapeutics

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for Pegunigalsidase Alf...

                            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 effica...

                            Brand Name : PRX–102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            February 24, 2023

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Protalix BioTherapeutics

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Chiesi Group

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance...

                            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 d...

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            December 05, 2022

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Chiesi Group

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Chiesi Global Rare Diseases

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Resubmission of Biologics License Applicatio...

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

                            Brand Name : PRX–102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            November 14, 2022

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Chiesi Global Rare Diseases

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Chiesi Group

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Protalix BioTherapeutics

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Chiesi Global Rare Diseases Announces Presentations on Lysosomal Storage Diseases at the Society for the Study...

                            Details : 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 Fab...

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            September 02, 2022

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Protalix BioTherapeutics

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Chiesi Group

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Regulatory Update on PRX-102 for the Treatmen...

                            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 sho...

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            October 11, 2021

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Chiesi Group

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Fabry Di...

                            Details : 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.

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            June 02, 2021

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for...

                            Details : 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.

                            Brand Name : PRX–102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            February 10, 2021

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Launch of Expanded Access Program in the U.S...

                            Details : Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            October 02, 2020

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            10

                            Protalix BioTherapeutics

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                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Protalix BioTherapeutics Completes Treatment Period for its Phase III BRIGHT Clinical Trial of Pegunigalsidase...

                            Details : The BRIGHT study is a phase III, open label, switch over study to assess the safety, efficacy and pharmacokinetics of pegunigalsidase alfa 2 mg/kg administered by intravenous infusion in patients with Fabry disease currently treated with enzyme replaceme...

                            Brand Name : PRX-102

                            Molecule Type : Large molecule

                            Upfront Cash : Not Applicable

                            August 24, 2020

                            Lead Product(s) : Pegunigalsidase alfa

                            Therapeutic Area : Genetic Disease

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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