Our Business Development Strategy
At Catalyst, our mission is to bring innovative and transformative therapies to patients with rare, debilitating neuromuscular and neurological diseases. Strategic partnerships with other leading companies in the field drive both our Portfolio Growth and Geographic Expansion and enable Catalyst to continuously improve on our ability to deliver on our mission. Our strong commercial infrastructure, expertise in neuromuscular and neurological diseases, and demonstrated success as a leading rare disease company with long-term growth make us an ideal partner.
Portfolio Growth
BioMarin
In October 2012, Catalyst agreed to a sublicense from BioMarin for the exclusive North American rights to FIRDAPSE® (amifampridine) Tablets 10 mg which was subsequently approved by the FDA in November 2018 for the treatment of adults with LEMS under the tradename and launched by Catalyst in early 2019. In 2022, a supplemental NDA received approval for its use in LEMS patients aged 6 and older.
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 S.A. acquired BioMarin’s overall license for the product and SERB S.A. is currently Catalyst’s global partner and licensor for FIRAPSE®.
Fycompa
In Jan 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) in multiple strengths and dosage forms from Eisai Co. Ltd. FYCOMPA is a commercial product in the U.S. approved alone or in combination with other medicines to treat partial-onset seizures with or without secondarily generalized seizures in patients aged 4 years and older and in combination with other medicines to treat primary generalized tonic-clonic seizures in patients aged 12 years and older.
Santhera
In Jul 2023, Catalyst entered into a strategic collaboration with Santhera Pharmaceuticals Holding AG (Santhera) for the exclusive North American rights to AGAMREE® (vamorolone) oral suspension, a treatment for patients 2 years and older suffering with DMD that was subsequently approved by the FDA in October 2023 and launched by Catalyst in the United States in March 2024. The agreement also provides Catalyst with both a right of first negotiation for rights in Europe and Japan in the event Santhera opts to license those rights as well as North American rights for any future approved indications of vamorolone.
Geographic Expansion
KYE Pharmaceuticals
In Aug 2020, after receiving a Notice of Compliance from Health Canada for its New Drug Submission for FIRDAPSE, Catalyst granted an exclusive sublicense to KYE Pharmaceuticals for the rights to commercialize FIRDAPSE in Canada.
Dydo Pharmaceuticals
In Jun 2021, Catalyst granted an exclusive sublicense to Dydo Pharmaceuticals for the rights to develop and commercialize FIRDAPSE for the treatment of LEMS in Japan.
Contact Catalyst’s Business Development Team
Catalyst is actively seeking opportunities to develop and commercialize transformative products in rare disease as well as ex-US partners who can help bring our products to patients in need. To discuss potential partnering opportunities, please contact our Strategy, Business Development & Partnering team, led by our highly experienced Chief Strategy Officer, Preethi Sundaram.
