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Details:
M8 will register, market and commercialize SERB's supportive oncology product Voraxaze (glucarpidase), a carboxypeptidase that reduces toxic plasma methotrexate concentration, in Latin America.
Lead Product(s): Glucarpidase
Therapeutic Area: Pharmacology/Toxicology Product Name: Voraxaze
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SERB Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 20, 2024
Details:
Company recieved positive opinion of CHMP of Voraxaze® (glucarpidase) based on clinical data and real world experience. Voraxaze reduces toxic plasma methotrexate concentration in adults and children may quickly lower MTX levels and avoid further systemic damage.
Lead Product(s): Glucarpidase
Therapeutic Area: Pharmacology/Toxicology Product Name: Voraxaze
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: BTG Specialty Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2021
Details:
Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function.
Lead Product(s): Glucarpidase
Therapeutic Area: Pharmacology/Toxicology Product Name: Megludase
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BTG Specialty Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
BTG Specialty Pharmaceuticals has a portfolio of market-leading emergency care products, including CroFab®, Voraxaze®, and DigiFab®.
Lead Product(s): Glucarpidase
Therapeutic Area: Pharmacology/Toxicology Product Name: Voraxaze
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Serb
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 02, 2021
Details:
An ongoing arm of the study triggered by the difficult circumstances created by the COVID-19 pandemic is exploring the planned use of Voraxaze® (glucarpidase) to enable high dose MTX treatment of CNSL on an outpatient basis.
Lead Product(s): Glucarpidase,Methotrexate
Therapeutic Area: Neurology Product Name: Voraxaze
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 November 12, 2020
Details:
In this study, adult patients with isolated CNSL are treated with rituximab and methotrexate administered for eight cycles. Voraxaze® is given 24 hours following start of each methotrexate infusion.
Lead Product(s): Glucarpidase,Methotrexate,Rituximab
Therapeutic Area: Oncology Product Name: Undisclosed
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 April 23, 2020
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