Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company based in Coral Gables, Florida. The company is developing therapeutics for rare neurological diseases, including the phosphate salt of amifampridine for the treatment of Lambert–Eaton myasthenic syndrome (LEMS) under the trade name "Firdapse" which was approved by the United States Food and Drug Administration (FDA) for use in Adult LEMS patients on November 28, 2018 and commercially launched in January 2019. On February 4, 2019, Bernie Sanders, United States Senator from Vermont, requested an explanation—including financial and non-financial information—from Catalyst that would justify Catalyst resetting Firdapse's list  price at $375,000 a year. Prior to the FDA approval, patients were able to get an experimental version of the drug for free through compassionate use programs in accordance with FDA Rules and Guidelines. History. Catalyst was founded in 2002, and completed an IPO in 2006. It focused primarily on developing therapies to prevent addiction until 2012. In 2009, Catalyst in-licensed worldwide rights to a family of GABA inhibitors including CPP-115 from Northwestern University. In 2012, it in-licensed patents covering the use of amifampridine phosphate to treat LEMS for the North American market from BioMarin. In 2018 , Catalyst terminated its license for CPP-115 with Northwestern and stopped the development program for that compound. Criticism. On February 4, 2019, Bernie Sanders, United States Senator from Vermont, publicly sent a letter to Catalyst asking why they raised the price of their drug Firdapse to an annual cost of $375,000, considering Firdapse was previously free of charge through an FDA compassionate use program . Sanders questioned the financial decision with regards to the negative impact, specifically asking about how many patients would suffer or die, for patients who may no longer be able to afford the drug. The drug is  used to treat Lambert–Eaton myasthenic syndrome (LEMS), which is a rare neuromuscular disorder. Prior to the price change, patients were able to get the drug for free through a U.S. Food and Drug Administration (FDA) compassionate use program.