Catalyst Pharmaceuticals said today it will eliminate 30% of its workforce—approximately seven jobs—in a move to conserve cash as it completes an already delayed NDA submission for its lead product.
Catalyst said it will immediately lay off employees now part of the company’s commercial team. Based in Coral Gables, FL, the company had 23 employees as of March 11.
“The decision to reduce the Company's workforce has been extremely difficult, but we believe that it is a necessary step to better align our resources and enable us to achieve our goal of bringing Firdapse to market for patients with LEMS [Lambert-Eaton myasthenic syndrome] and CMS [congenital myasthenic syndromes],” Catalyst Chairman and CEO Patrick J. McEnany said in a statement.
The workforce reduction comes 3 months after Catalyst’s February 17 disclosure that it received a “refusal to file” letter from the FDA pending completion of additional studies to support the NDA for Firdapse® (amifampridine phosphate). The company aims to win FDA approval of Firdapse for the treatment of LEMS and CMS.
On April 26, Catalyst said that in addition to results of its already submitted multicenter, randomized, placebo-controlled Phase III LMS-002 trial, the FDA had requested that the company also submit positive results from several more short-term toxicology studies and an additional “adequate and well-controlled” study in patients with LEMS. At the time, Catalyst said the FDA was open to discussing a design for a “small, short-term study” that could efficiently accomplish the requirement.
The company and the FDA were still in talks as of last week: “We are currently engaged in dialogue with the FDA with regard to logistics required for our path forward and will provide an update once we have more clarity,” McEnany stated on May 10.
Today, Catalyst said that it continues to believe that its current resources will be sufficient to complete and refile an NDA for Firdapse for LEMS and CMS.
The company finished the first quarter with a GAAP net loss of $5,386,237, less than the $5,410,259 GAAP loss reported for Q1 2015, despite a 51% year-over-year jump in R&D expenses for reasons that included consulting on regulatory affairs and Firdapse’s expanded access program, including manufacture of the drug.
In its announcement of the layoffs today, Catalyst said it will continue to grow its expanded access program for Firdapse with participating physicians and eligible patients with LEMS and CMS.
Firdapse is the first and only drug approved in Europe for symptomatic treatment in adults with LEMS.
In the U.S., Firdapse has received the FDA’s Breakthrough Therapy Designation for the treatment of LEMS, as well as Orphan Drug Designations for LEMS and CMS.