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Details:
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DyDo Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
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 13, 2023
Details:
Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
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 23, 2023
Details:
A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Ruzurgi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: KYE Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Details:
FIRDAPSE® (amifampridine phosphate) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium channel blocker that causes depolarization of presynaptic membrane and slows or inhibits repolarization for treatment of adults with Lambert-Eaton myasthenic syndrome.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
U.S. FDA approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg under the Orphan Drug Act.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Ruzurgi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
Details:
Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States as a treatment for adults with LEMS.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
DyDo Pharma will have joint rights to develop Firdapse® (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. Firdapse® is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that slows or inhibits repolarization.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DyDo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 28, 2021
Details:
KYE Pharmaceuticals announces FIRDAPSE® (amifampridine phosphate), the first amifampridine product approved in Canada, is now widely available for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Médunik Canada has retained the services of Innomar, a leading specialty pharmaceutical service and patient support program provider, for the distribution of Ruzurgi® and management of its UnikAccess Patient Support Program.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Ruzurgi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jacobus Pharmaceutical Company, Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
Under the terms of the agreement, Catalyst will supply Firdapse® to KYE and KYE will be responsible for promotion, sales, advertisement, marketing, product importation and distribution.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Catalyst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 18, 2020
Details:
The allowed application, "Methods of Administering 3,4-Diaminopyridine", claims a method of treating a human patient diagnosed with a 3,4-DAP sensitive disease by administering 3,4-DAP to slow acetylating patients having certain mutations in each allele of the NAT2 gene.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
The marketing application submitted to Health Canada included safety and efficacy data from Catalyst’s two previously reported multi-national clinical trials evaluating Firdapse® for the treatment of patients with LEMS.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Product Name: Firdapse
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
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