Coral Gables, FL-based Catalyst Pharmaceuticals, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of therapies targeting rare neurological diseases and disorders such as Lambert-Eaton myasthenic syndrome (LEMS), epilepsy (initially infantile spasms) and Tourette syndrome.
In October 2012, Catalyst had in-licensed rights to Firdapse from BioMarin Pharmaceutical Inc. for the development and commercialization of the product in the United States. Firdapse is currently approved in the European Union as well as in the United States for the symptomatic treatment of LEMS in adults. LEMS is an ultra-rare disease and the company estimates approximately 3,000 LEMS patients in the United States.
The drug is also being studied for additional indications. Catalyst has initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG.The company is also working on a generic version of Lundbeck’s Sabril (vigabatrin), CPP-109, which is marketed by for the treatment of infantile spasms and complex partial seizures.
Meanwhile, in October 2020, the United States Patent and Trademark Office (USPTO) issued a new U.S. patent to Catalyst Pharmaceuticals for Firdapse, U.S. Patent No. 10,793,893, Methods of Administering 3,4-Diaminopyridine, expiring April 7, 2034.
Catalyst recorded revenues worth $119.1 million in 2020, reflecting an increase of 16% on a year-over-year basis.