Drugs in Dev. Genetic Disease
Phase III
Israel 
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
December 05, 2022
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
November 14, 2022
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Alpha1-proteinase Inhibitor,Alpha-1 Antitrypsin
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRAB® as well as its recently acquired FDA approved plasma derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF.
Product Name : Glassia
Product Type : Protein
Upfront Cash : Inapplicable
November 07, 2022
Lead Product(s) : Alpha1-proteinase Inhibitor,Alpha-1 Antitrypsin
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
October 11, 2021
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
June 02, 2021
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
February 10, 2021
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
October 02, 2020
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
August 24, 2020
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.
Product Name : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
August 11, 2020
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Chiesi Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The BLA has been filed for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa a long-acting recombinant, PEGylated, cross-linked α-galactosidase-A produc...
Product Name : Elfabrio
Product Type : Enzyme
Upfront Cash : Inapplicable
May 28, 2020
Lead Product(s) : Pegunigalsidase Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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