Catalyst Pharmaceutical Partners Inc. announced the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) about Firdapse(TM) tablets (Amifampridine), its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Catalyst provided FDA with an update on the development program for Firdapse, which received Breakthrough Therapy designation from the FDA in August 2013. The Company also confirmed with FDA the clinical, nonclinical, and chemistry and manufacturing controls requirements that FDA will require to approve a New Drug Application (NDA) for Firdapse.

This Type B meeting with the FDA was Catalyst's first meeting as the sponsor of the IND for Firdapse. Catalyst will file rolling submissions of the NDA modules as completed in anticipation of receiving a priority review of its NDA for Firdapse. The Company provided a briefing package to the FDA that described all completed, in-progress, and planned preclinical studies, clinical studies, and drug manufacturing activities.

This package included summaries of 54 preclinical studies, six clinical studies, and information related to drug manufacturing (the clinical supplies and the to-be marketed commercial product). The FDA concurred that the Company's completed, in-progress, and planned development activities represented a nearly complete package of information that would be needed for a complete NDA. Catalyst also will submit data from additional in-vitro preclinical studies.

Based on the discussions at this meeting and based on past communications and meetings with the FDA about Firdapse, all of these studies and remaining development activities constitute information needed to file a complete NDA and seek approval for Firdapse. The Company does not anticipate that these additional studies will impact the NDA filing timeline or materially add to its forecast of the aggregate development costs for Firdapse.