Catalyst, KYE Agree to Commercialize Firdapse for Adult LEMS Patients in Canada

Catalyst Pharmaceuticals and KYE Pharmaceuticals have reached an exclusive agreement that will enable KYE to commercialize Firdapse (amifampridine), Catalyst’s oral therapy for adults with Lambert-Eaton myasthenic syndrome (LEMS), in Canada.

The announcement comes after the medication was approved by Health Canada earlier this month.

“Catalyst remains focused on making a meaningful impact in the lives of those suffering from rare diseases. We are excited to partner with the experienced team at KYE in making Firdapse available to LEMS patients throughout Canada,” Patrick J. McEnany, chairman and CEO of Catalyst, said in a press release.

Under the terms of the agreement, Catalyst will be responsible for providing supplies of Firdapse to KYE, while KYE will be in charge of advertising, promoting, importing, distributing, and selling the therapy.

In addition, KYE (whose headquarters are in Canada) will be responsible for maintaining Firdapse’s regulatory information in the country, and for all future communications with Health Canada.

“Partnering with Catalyst to make Firdapse available to LEMS patients in Canada allows us to continue fulfilling our goal to bring critically needed medicines to Canadian patients and the healthcare community. We look forward to working with the experienced and talented Catalyst team in the years ahead,” said Doug Reynolds, co-founder and president of KYE.

LEMS is caused by the production of autoantibodies — immune proteins that mistakenly attack the body’s own tissues or organs — against voltage-gated calcium channels (VGCC) found at the end of nerve cells. Such channels are important for the cells’ intake of calcium, needed for the release of tiny vesicles containing acetylcholine — a chemical messenger — into the neuromuscular junction, which is the site where nerve cells communicate with muscles. This induces muscle contraction by improving the communication between nerve cells and muscles.

Originally developed by BioMarin Pharmaceuticals, Firdapse is a small-molecule therapy that blocks another channel, known as the voltage-dependent potassium channel, to maintain the remaining VGCCs open so that calcium ions enter nerve cells.

Firdapse, given in 10 mg tablets, also has been available in the U.S. since 2018, in the European Union since 2009, and elsewhere. Catalyst has held the rights to Firdapse in North America from BioMarin since 2012.