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Details:
Panbela has regained the North American rights to develop and commercialize Flynpovi (the combination of CPP-1X (eflornithine hydrochloride) and sulindac) in patients with FAP. The drug is withdrawn form the european market and company will conduct FAP trial for phase 3.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: One-Two Therapeutics Assets Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination April 11, 2023
Details:
Flynpovi (eflornithine hydrochloride) is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
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 October 06, 2022
Details:
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. The safety profile for Flynpovi did not differ from the single agents and supports the evaluation for FAP.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Panbela Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 16, 2022
Details:
The combined entity will have an expanded pipeline addressing focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer, including Flynpovi, the lead asset.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Oncology Product Name: Flynpovi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Panbela Therapeutics
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 22, 2022
Details:
Although the trial did not demonstrate that overall disease progression was significantly lower with CPP-1X/sul compared to eflornithine or sulindac alone, in a subgroup of patients with intact colons there was a 70% decreased risk of disease progression with CPP-1X/sul.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
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 September 11, 2020
Details:
The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
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 June 29, 2020
Details:
Cancer Prevention Pharmaceuticals plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration this month seeking accelerated approval for CPP-IX/sul for the same indication.
Lead Product(s): Eflornithine,Sulindac
Therapeutic Area: Genetic Disease Product Name: CPP-1X/sul
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 June 18, 2020
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