Catalyst Pharmaceutical Partners, Inc. Will Hire 25 Staffers After Successful Drug Trial
October 7, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Florida-based Catalyst Pharmaceutical Partners, Inc. announced on Oct. 6 that it will hire between 25 and 35 new staff members to bring a new drug to the market.
The South Florida Business Journal reports that the company is looking to receive approval from the U.S. Food and Drug Administration for Firdapse, which is designed to treat Lambert-Eaton myasthenic syndrome. This disease weakens the muscles in patients, and Catalyst recently received positive phase 3 trial results for the drug.
“We’ve got a relatively small pipeline, but we’re working on really serious diseases,” Catalyst CEO Pat McEnany told the news source. “There’s an unmet medical need for FDA-approved therapies [for these diseases], not off-label therapies.”
The Progression of Firdapse
Catalyst announced the results of its phase 3 clinical trial for Firdapse on Sept. 29, and the results showed that the drug was superior to the placebo. Firdapse, also known asamifampridine phosphate tablets, was tested to determine its impact against Lambert-Eaton myasthenic syndrome. The drug met its primary endpoints, quantitative myasthenia gravis score and subject global impression.
"These results show that Firdapse provides an important benefit to LEMS patients and continues to demonstrate a favorable safety profile,” said McEnany following the release of the results. “We plan to meet with the FDA in the near future to determine the fastest way to get an NDA for Firdapse approved. We are committed to the LEMS patient community and are pleased that we will be launching our expanded access program next month. This program will provide Firdapse at no charge to patients who meet the inclusion/exclusion requirements."
The clinical trial was a randomized, double-blind study in which patients were treated with the drug over the course of 91 days, then either treated with the placebo or the drug during a two-week randomization period.
"Having well-controlled phase 3 clinical trials and ultimately an FDA-approved medication is an important step forward for all LEMS patients,” said Natacha Pires, director of medical and public affairs at The Neuropathy Association. “We are pleased to see companies like Catalyst investing in the development of therapies for patients with these rare muscular degenerative diseases."
Catalyst plans to present more information on the phase 3 trial on Oct. 12 in a presentation at the 139th Annual Meeting of the American Neurological Association in Baltimore, Md.