Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: SERB Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 20, 2024

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            Under the agreement, Meridian will supply DuoDote to the Administration for Strategic Preparedness and Response within the United States. DuoDote® is an FDA-approved dual-chamber autoinjector (atropine and pralidoxime chloride) chemical nerve agent antidote.

            Lead Product(s): Atropine,Pralidoxime Chloride

            Therapeutic Area: Pharmacology/Toxicology Product Name: DuoDote

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: ASPR

            Deal Size: $9.9 million Upfront Cash: Undisclosed

            Deal Type: Agreement November 14, 2023

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            Rising Pharmaceuticals

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            Details:

            Edetate calcium disodium for injection is a prescription medicine, used for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.

            Lead Product(s): Edetate Calcium Disodium

            Therapeutic Area: Pharmacology/Toxicology Product Name: Edetate Calcium Disodium-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2023

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: BTG Specialty Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 25, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: BTG Specialty Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2021

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            Details:

            KLOXXADOTM contains twice as much naloxone per spray as Narcan® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.

            Lead Product(s): Naloxone Hydrochloride

            Therapeutic Area: Pharmacology/Toxicology Product Name: Kloxxado

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 30, 2021

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            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: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Serb

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition March 02, 2021

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