Benzinga | Dec 6, 2021 07:14AM EST

Catalyst Pharmaceuticals Announces DyDo Pharma Initiation Of A Phase 3 Study For FIRDAPSE In Japan

Catalyst Pharmaceuticals, Inc. (Catalyst) (NASDAQ:CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today announced that its collaboration partner DyDo Pharma ("DyDo") has initiated a Phase 3 registrational study in Japan to evaluate the efficacy and safety of Catalyst's FIRDAPSE(r) (amifampridine) 10 mg tablets for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").

"We are pleased with the important progress being made by DyDo as we advance on our shared commitment of bringing a novel treatment option to LEMS patients in Japan," said Patrick McEnany, CEO and Chairman of Catalyst. "The initiation of this Phase 3 program marks an important milestone towards our goal to expand the global footprint of FIRDAPSE for the treatment of LEMS. Currently, there are no approved treatments for this rare autoimmune neuromuscular disorder in Japan, and we believe FIRDAPSE has the potential to provide a meaningful new therapy option to patients living with this disease. We appreciate the collaborative effort of our partnership and look forward to continuing to support DyDo in the clinical advancement of FIRDAPSE."

Catalyst entered into a sub-license agreement with DyDo to develop and commercialize FIRDAPSE in Japan in June 2021. Under the terms of the agreement, Catalyst will provide clinical and commercial supply to DyDo and technical support to obtain regulatory approval for the product from the Japanese regulatory authorities. DyDo is responsible for the development and commercialization of the product in Japan pending regulatory approval, and Catalyst will be entitled to development and sales milestones and revenue for clinical and commercial supply of the product.