The Florida-based company points to inaccuracies in the letter Sanders sent earlier this month regarding the price of LEMS treatment Firdapse.
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Earlier this month U.S. Sen. Bernie Sanders called out Florida-based Catalyst Pharma over the price for its recently-approved drug, Firdapse (amifampridine) and accused it of repurposing an old drug in order to gouge patients. Now the company is firing back.
On Thursday, the company responded to the senator’s complaints in a letter posted on the company’s website. In its response, the company said that Sanders, who has a long history of publicly calling out pharmaceutical companies over the price of medications, was inaccurate in his condemnation of the company.
In the letter, Sanders claimed that the Catalyst drug, a first-ever approved treatment for Lambert-Eaton myasthenic syndrome (LEMS) in the United States, had been available for free from another manufacturer. Following the November 2018 approval from the U.S. Food and Drug Administration, Catalyst set a list price of $375,000 for the treatment. Sanders called the $375,000 price tag for Firdapse exploitative and said that patients in America “America should not be allowed to suffer or die because of the greed of a drug company.” Sanders questioned how many patients will suffer or die due to the cost of the drug. In its response to Sanders, Catalyst noted that there were patients who received a LEMS drug for free, but only about 200 of the approximately 3,000 patients in the U.S. As BioSpace reported when Sanders fired his first shot, the family-owned Jacobus Pharmaceutical has given away treatments to 200 patients battling LEMS. The medication, known as 3,4-DAP, had not been approved by the FDA for LEMS and was provided to the patients under the regulatory agency’s compassionate use program.
“The approval of Firdapse by the FDA means that all LEMS patients in the United States now have access to this much-needed medication,” Catalyst said in its response.
Because the Jacobus treatment had never been approved by the FDA, Catalyst said it “respectfully questions” the idea that the use of an experimental product that has not been approved by the FDA is “an acceptable standard of care for LEMS patients,” or for any other patients.
Regarding the price of the medication, Catalyst said it has developed an “array of financial assistance programs” that can reduce co-pays and deductibles to affordable levels. The company said in most cases, with the financial plans in place, as well as with insurance programs, the monthly out-of-pocket expenses by most patients are on average about $10.
Catalyst also challenged Sanders’ notion that the approved Firdapse is an old drug. The company said it is neither old nor repurposed. Until the FDA approval of Firdapse, Catalyst said an amifampridine-based product had never been approved in the United States for any indication. Because of that, it received a new chemical entity designation from the regulatory agency.
The company also pointed out the enormous expenses it undertook in order to gain approval. Prior to its November approval, Firdapse was previously rejected by the FDA, which caused the company to cut a considerable number of employees to preserve cash flow. Approval cost the company millions of dollars and Catalyst said it continues to spend millions of dollars evaluating the medication as a potential treatment for other indications where there is no approved treatment.
