113  0 Kommentare Catalyst Pharmaceuticals Announces FIRDAPSE New Drug Application Submitted in Japan by Partner DyDo Pharma

CORAL GABLES, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that its collaboration partner, DyDo Pharma, Inc. ("DyDo"), reported that it has submitted a New Drug Application (“NDA”) to Japan's Pharmaceuticals and Medical Devices Agency (“PMDA”) seeking marketing approval for FIRDAPSE  (amifampridine) Tablets 10 mg (generic name: amifampridine phosphate), for the treatment of Lambert Eaton myasthenic syndrome ("LEMS") in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS. The review period is expected to be approximately a minimum of nine months from the submission date.

“The NDA submission to the PMDA by our partner DyDo represents a pivotal milestone in our mission to broaden FIRDAPSE’s access as a treatment for LEMS patients in Japan,” stated Patrick J. McEnany, Catalyst’s Chairman and CEO. “Given the absence of therapies available in Japan for this rare neuromuscular disorder, we believe that if approved, FIRDAPSE holds the potential to be a novel treatment option for Japanese individuals grappling with this condition. As we continue to collaborate with our partner during the review process, the submission also triggers an expansion of our territorial rights for the product and a milestone payment to Catalyst. We look forward to initiating our plans to expand the reach for FIRDAPSE into other global regions seeking a novel therapy for the treatment of LEMS.”

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In June 2021, Catalyst entered into a license agreement with DyDo for the development and commercialization of FIRDAPSE in Japan. Under the terms of the agreement, Catalyst is eligible to receive a regulatory milestone payment from DyDo upon submission of the NDA to the PMDA. Under the Company’s license agreement with SERB S.A., upon acceptance of the NDA submission to the PMDA in Japan, Catalyst’s territorial rights to develop and market the product will automatically extend to other key markets in Asia, Central, and South America. The Company is currently initiating plans to seek opportunities to expand the product’s global footprint through strategic partnerships, with a current focus on the Asia Pacific and Latin American regions.