Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Health Canada Accepts AGAMREE NDA for Duchenne Muscular Dystrophy
Details : Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 08, 2025
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Recipient : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Catalyst Pharmaceuticals Enters License Agreement with Kye for AGAMREE® in Canada
Details : Under the terms of the agreement, Kye will have the exclusive Canadian rights to commercialize Agamree (vamorolone) and will be responsible for funding all regulatory and commercialization activities.
Product Name : Agamree
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 24, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Recipient : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Recipient : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 03, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Recipient : Catalyst Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
KYE Pharmaceuticals Announces Commercial Availability of FIRDAPSE in Canada
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.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 28, 2020
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Recipient : Tris Pharma Inc
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the terms of the agreement, KYE has received exclusive rights to commercialize Tris' FDA-approved ADHD product portfolio in Canada. Also, KYE will handle all ongoing Canadian regulatory activities for the products.
Product Name : Quillivant XR
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 07, 2020
Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Recipient : Tris Pharma Inc
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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.
Product Name : Firdapse
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 18, 2020
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement