Benzinga | Jun 28, 2021 08:11AM EDT

Catalyst Pharmaceuticals Announces Exclusive License And Supply Agreement With DyDo Pharma For Development And Commercialization Of Firdapse In Japan; Financial Details Not Disclosed

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 it has entered into an exclusive license and supply agreement with DyDo Pharma, Inc. ("DyDo Pharma") for the development and commercialization of Firdapse(r) (amifampridine) Tablets 10 mg in Japan for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). LEMS is a rare autoimmune neuromuscular disorder characterized by debilitating and progressive muscle weakness and fatigue.



Under the terms of the agreement, DyDo Pharma will have joint rights to develop Firdapse(r) (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. DyDo Pharma will be responsible for funding all clinical, regulatory, marketing and commercialization activities in Japan. Catalyst will be responsible for clinical and commercial supply, as well as providing support to DyDo Pharma in its efforts to obtain regulatory approval for the product from the Japanese regulatory authorities. Subject to the satisfaction of terms and conditions as set forth in the License and Supply Agreement, Catalyst will receive an upfront payment and be eligible to receive further development and sales milestones for Firdapse(r), as well as a transfer price on product supplied to DyDo Pharma.

"DyDo Pharma's experienced team and commitment to rare diseases makes the company an attractive choice for Catalyst for the development and distribution of our amifampridine product for the treatment of LEMS in Japan," said Patrick J. McEnany, Chairman and CEO of Catalyst. "Given the limited availability of treatment options for LEMS in Japan, we look forward to working with DyDo Pharma to address this unmet medical need by hopefully providing a new treatment option for patients and their families."

"We are very pleased to have acquired a license for the Japanese rights for Firdapse(r), which Catalyst sells in the United States," said Yasunori Inaoka, president and representative director of DyDo Pharma. "Going forward, we will pursue development with the goal of obtaining marketing authorization approval for Firdapse(r) as a treatment for LEMS in Japan, so that we can offer a new therapeutic option to Japanese LEMS patients who with their families are currently suffering in the absence of an approved treatment."

MTS Health Partners, L.P. served as financial advisor to Catalyst on the transaction.