Catalyst Pharma Reports Breakthrough Therapy Designation for Firdapse for LEMS

Catalyst PharmaceuticalPartners, Inc. (Nasdaq: CPRX), a specialty pharmaceutical company focused onthe development and commercialization of novel prescription drugs targetingrare (orphan) neuromuscular and neurological diseases, today announced thatits investigational product Firdapse™ (amifampridine phosphate) has received"Breakthrough Therapy Designation" by the U.S. Food and Drug Administration(FDA) for the symptomatic treatment of patients with Lambert-Eaton MyasthenicSyndrome (LEMS). Firdapse™ is Catalyst's investigational therapy that is beingevaluated for the treatment of the debilitating symptoms associated with LEMS,including muscle weakness."We are very pleased to have received Breakthrough Therapy Designation forFirdapse™ and we are excited by the FDA's decision to place our product in acategory that may enable expedited development and review for patients withLEMS," said Patrick McEnany, President and Chief Executive Officer ofCatalyst. "With no approved or effective symptomatic treatment currentlyavailable for LEMS, Firdapse™ has the potential to be the first-line treatmentoption for patients with this rare condition."Breakthrough Therapy Designation for Firdapse™ was based on clinical data fromseveral previously published clinical trials of amifampridine (3,4-DAP) inpatients with LEMS. Firdapse™ has the potential to provide significant reliefof the often debilitating symptoms of the disease, including muscle weakness(e.g. difficulty walking), difficulty swallowing and talking, drooping ofeyelids and facial weakness.