Catalyst Pharmaceuticals Announces DyDo Pharma Initiation of a Phase 3 Study for FIRDAPSE® (amifampridine) in Japan
"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
Catalyst entered into a sub-license agreement with DyDo to develop and commercialize FIRDAPSE in
About FIRDAPSE® (amifampridine) Tablets 10 mg
FIRDAPSE® (amifampridine) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization. This action results in the opening of slow voltage-dependent calcium (Ca2+) channels, allowing for a subsequent influx of Ca2+. In turn, it induces the exocytosis of synaptic vesicles containing Acetylcholine (ACh) to release more ACh into the synaptic cleft, enhancing neuromuscular transmission and providing for improved muscle function. FIRDAPSE was granted orphan drug designation by the Ministry of Health,
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further,
About DyDo Pharma
DyDo Pharma is the rare disease pharmaceutical wholly owned subsidiary of DyDo Group Holdings. DyDo Group Holdings, Inc. operates through the following segments: Domestic Beverage Business, International Beverage Business, Pharmaceutical-related Business, Food Business, and Other Businesses. The Domestic Beverage Business accounts for more than 70% of total sales, and beverages are sold through vending machines that are widely prevalent in Japan. The company was founded on January 27, 1975, and is headquartered in Osaka,
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether DyDo Pharma's clinical trial in
Investor ContactMary Coleman Catalyst Pharmaceuticals, Inc. (305) 420-3200 mcoleman@catalystpharma.com Media ContactDavid Schull Russo Partners (858) 717-2310 david.schull@russopartnersllc.com
Source: Catalyst Pharmaceuticals, Inc.