Partnering with Catalyst
We take a careful approach, assessing each opportunity based on its unique merits and evaluating the potential to transform healthcare.
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In July 2023, Catalyst completed our acquisition of an exclusive license for North America for AGAMREE, a treatment for patients with Duchenne muscular dystrophy (DMD) from Santhera Pharmaceuticals Holdings (Santhera). Additionally, Catalyst holds the North American rights for any future approved indications of AGAMREE. AGAMREE previously received FDA Orphan Drug and Fast Track designations. On October 26, 2023, the FDA approved AGAMREE oral suspension 40 mg/mL for the treatment of DMD in patients aged two years and older. On March 13, 2024, Catalyst launched AGAMREE in the US.
In July 2024, Catalyst entered into a License, Supply and Commercialization Agreement with Kye providing the exclusive Canadian commercial rights to AGAMREE. Under the terms of the agreement, Catalyst will supply the product to Kye, who will assume full responsibility for obtaining regulatory approval for AGAMREE for the treatment of DMD from Health Canada and all future aspects of commercialization of the product within Canada. On October 2, 2025, Kye announced that Health Canada approved AGAMREE for the treatment of DMD in boys age 4 and older.
Please see full Prescribing Information for additional Important Safety Information.
In October 2012, Catalyst agreed to a sublicense from BioMarin for the exclusive North American rights to FIRDAPSE Tablets 10 mg. Catalyst’s New Drug Application (NDA) for FIRDAPSE for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS) was approved in 2018 by the US Food & Drug Administration (FDA), and today FIRDAPSE is commercially available in the US as a treatment for LEMS.
In May 2019, Catalyst and BioMarin amended that agreement to provide Catalyst with exclusive rights to the product in Japan and potential rights for parts of Asia and Central & South America. In January 2020, SERB SA acquired BioMarin’s overall license for the product, and SERB SA is currently Catalyst’s global partner and licensor for FIRDAPSE.
Catalyst entered into a license and supply agreement with KYE Pharmaceuticals (KYE) in July 2024. Canada’s national healthcare regulatory agency, Health Canada, approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS in 2020 and FIRDAPSE is now commercially available in Canada for the treatment of patients with LEMS.
In June of 2021, Catalyst entered into an exclusive license and supply agreement with DyDo Pharma, Inc for the development and commercialization of FIRDAPSE Tablets 10 mg in Japan for the treatment of LEMS. In September 2024, Japan’s national healthcare regulatory agency, the Ministry of Health, Labour and Welfare (MHLW), approved the use of FIRDAPSE for the treatment of patients in Japan with LEMS. FIRDAPSE became commercially available in Japan in January 2025, meeting a significant unmet need for patients in the region.
Please see full Prescribing Information for additional Important Safety Information.
On December 17, 2022, we entered into an asset purchase agreement with Eisai Co., Ltd (Eisai) for the acquisition of the US rights to FYCOMPA.
FYCOMPA is a prescription medication used alone or in combination with other medicines to treat focal onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older and with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older.
We closed the acquisition of the US rights to FYCOMPA on January 24, 2023, and Catalyst currently makes FYCOMPA available in the US.
FYCOMPA may cause mental (psychiatric) problems, including:
new or worse aggressive behavior (including homicidal thoughts and threats), hostility, anger, anxiety, or irritability; being suspicious or distrustful (believing things that are not true); seeing objects or hearing things that are not there; confusion; difficulty with memory; other unusual or extreme changes in behavior or mood. Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.
Please see full Prescribing Information for additional Important Safety Information.
“Catalyst is proof that you can have a successful business while ensuring patients get treatments when and where they need them.”
—Jeff Del Carmen, Commercial
