Profile: Catalyst Pharmaceuticals Inc (CPRX.PH)
17 Jun 2019
Catalyst Pharmaceuticals, Inc., formerly Catalyst Pharmaceutical Partners, Inc., incorporated on July 21, 2006, is a development-stage biopharmaceutical company. The Company is focused on developing and commercializing therapies for people with rare debilitating diseases. The Company has three drugs in development: Firdapse, CPP-109 and CPP-115.
The Company's Firdapse is indicated for the treatment of lambert-eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS). Firdapse consists of the phosphate salt of amifampridine. The Company has completed the Phase III trial of Firdapse. The Phase III trial was designed as a double blind, randomized withdrawal trial in which all patients were initially treated with Firdapse during a 91-day run-in period followed by treatment with either Firdapse or placebo during a two-week randomization period.
The Company's CPP-109 (vigabatrin) is a gamma-aminobutyric acid (GABA) aminotransferase inhibitor. CPP-109 is indicated for the treatment of Tourette's Disorder. Vigabatrin is approved for human use (Sabril and Lundbeck) and CPP-109 is being employed as a research surrogate for exploring potential indications for which there are no adequate animal models.
The Company's CPP-115 is a GABA aminotransferase inhibitor. CPP-115 is indicated for the treatment of selected neurological indications, such as complex partial seizures and Tourette's Disorder, and epilepsy. The Company has completed the Phase Ib multi-dose safety and tolerance study of CPP-115. CPP-115 has been granted Orphan Drug Designation by the food and drug administration (FDA) for the treatment of infantile spasms and Orphan Medicinal Product Designation in the European Union, for West syndrome (a form of infantile spasms).
The Company competes with Jacobus Pharmaceutical, Pfizer, J&J, UCB, Abbott, GSK, Roche and Novartis.
Catalyst Pharmaceuticals Inc
355 Alhambra Cir Ste 1250
CORAL GABLES FL 33134-5038
Company Web Links
- Catalyst Pharma sues FDA over approval of cheaper rival drug
- UPDATE 2-Catalyst Pharma sues FDA over approval of cheaper rival drug
- Catalyst Pharma files lawsuit against U.S. FDA on Jacobus Pharma drug approval
- UPDATE 1-U.S. Senator Sanders urges FDA to allow older versions of $375,000 drug
- Catalyst Pharmaceuticals defends $375,000 drug price after Bernie Sanders rebuke