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Details:
Norgine will commercialize Pedmarqsi (sodium thiosulfate) in Europe, Australia and New Zealand. Pedmarqsi is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity induced by cisplatin chemotherapy in patients with localized, non-metastatic solid tumors.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmarqsi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Norgine
Deal Size: $271.6 million Upfront Cash: $43.4 million
Deal Type: Licensing Agreement March 18, 2024
Details:
The net proceeds will be used by the company for the commercialization of Pedmark (sodium thiosulfate), the only approved therapy for reducing the risk of hearing loss in pediatric cancer patients who receive treatment with platinum-based chemotherapy.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Petrichor
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing December 05, 2023
Details:
Pedmarqsi™ (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmarqsi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2023
Details:
Pedmark® (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2023
Details:
Pedmark® (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2023
Details:
Under the terms of the agreement, an additional is to be funded upon the potential U.S. Food and Drug Administration approval of PEDMARK (sodium thiosulfate) by September 30, 2022 and satisfaction of other closing conditions.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Petrichor Healthcare
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 22, 2022
Details:
PEDMARK (sodium thiosulfate), has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, the clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Petrichor Healthcare Capital Management
Deal Size: $45.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 01, 2022
Details:
87% of patients who experienced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020, a novel, proprietary formulation of sodium thiosulfate treated ear.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-020
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
PEDMARK is a small molecule, unique formulation of STS, is administered 6 hours post completion of cisplatin infusion in an intravenous bolus dose over 15 minutes, has potential to reduce the incidence of chemotherapy-induced hearing loss.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
PEDMARK™ (a unique formulation of sodium thiosulfate), is currently under evaluation by EMA, as an essential chemotherapeutic agent for many pediatric malignancies also has received breakthrough therapy and fast track designation.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2021
Details:
After recent completion of a pre-approval inspection of the manufacturing facility of Fennec's drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of practices that are required to be resolved prior to the approval of PEDMARK™.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Pedmark
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
Potential for PEDMARK to be the first product for the prevention of cisplatin-induced hearing loss in children.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2020
Details:
The Phase 1a trial showed that DB-020 was safe and well-tolerated in healthy volunteers and confirmed that administration of DB-020.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2020
Details:
The patent captures the use of Fennec’s PEDMARK product to reduce the ototoxic effects of cisplatin in pediatric patients.
Lead Product(s): Sodium Thiosulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2020
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