Catalyst Pharma Closes Enrollment in Pivotal Phase 3 Trial of Firdapse in Patients with Lambert-Eaton Myastenic Syndrome

Catalyst Pharmaceutical Partners, Inc.

, a specialty pharmaceutical company focused on developing safe and effective, approved medicines to treat orphan neuromuscular and neurological diseases, announced today that it has reached the patient enrollment target for its pivotal Phase 3 trial evaluating the safety and efficacy of Firdapse™ for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Based on the enrollment and randomization success metrics achieved to date, the Company believes that it has enrolled a sufficient number of LEMS patients to ensure that 36 patients will be randomized into the double-blind, placebo-controlled, discontinuation portion of the trial. The Company continues to screen additional, previously identified LEMS patients who have expressed interest in participating in this study. As allowed in the protocol for this study, all LEMS patients who are not randomized can continue to receive Firdapse™ as participants in the two-year follow-up period. "Completing enrollment in our LEMS trial marks a key milestone for Catalyst as we work towards bringing a safe, effective and FDA-approved therapeutic treatment to the LEMS patient community," said Patrick J. McEnany, Catalyst's Chairman and CEO. "We are on track to report top-line data from the double-blind portion of the trial in the third quarter. If the trial is successful, we expect to begin a rolling NDA filing with the FDA in early 2015, bringing us closer to providing broad access to an FDA-approved treatment for LEMS patients."