Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Protalix BioTherapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Chiesi & Protalix Announce EMA Validation for Pegunigalsidase Alfa Submission
Details : Elfabrio (pegunigalsidase alfa) is a globotriaosylceramide inhibitor enzyme drug candidate, which is being evaluated to label a less frequent dosing regimen for treating fabry disease.
Product Name : Undisclosed
Product Type : Large molecule
Upfront Cash : Not Applicable
December 09, 2024
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
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
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...
Product Name : PRX-102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Protalix BioTherapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Product Name : PRX–102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Product Name : PRX-102
Product 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
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
Details : PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme.
Product Name : PRX–102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Protalix BioTherapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Product Name : PRX-102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Product Name : PRX-102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Product Name : PRX-102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Product Name : PRX–102
Product 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
Lead Product(s) : Pegunigalsidase alfa
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Product Name : PRX-102
Product 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