Catalyst won approval in 2018 for the LEMS treatment and set the price of the drug at $375,000 for the rare disease.
Trevor Collens / Shutterstock
U.S. Sen. Bernie Sanders has a history of taking on the pharmaceutical industry and prices for prescription medicines that he sees as unjust. This week, the Vermont senator has found a new target, Florida-based Catalyst Pharmaceuticals.
On Monday, Sanders sent a letter to Patrick J. McEnany, chairman and chief executive officer of Catalyst Pharmaceuticals, in regards to the $375,000 price tag for its recently-approved drug, Firdapse (amifampridine). In November 2018, after a previous rejection, Catalyst won approval from the U.S. Food and Drug Administration for the oral drug, as a first-ever approved treatment for Lambert-Eaton myasthenic syndrome (LEMS). The disorder affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. It affects approximately one in 100,000 people in the United States and about 3 million people globally. Before finally achieving regulatory approval in the United States, Catalyst had co-marketed marketed a LEMS treatment in Europe it had licensed from BioMarin Pharmaceuticals. Analysts have pegged Firdapse to bring in about $325 million in annual revenue for Catalyst by 2025.
Sanders’ ire was raised over the price tag Catalyst slapped on Firdapse, which had a long road for regulatory approval. For 20 years, Sanders said LEMS patients were able to receive the same drug, known as 3,4-DAP, for free from Jacobus Pharmaceutical under the Food and Drug Administration’s compassionate use program. For years, the family-owned Jacobus has given away treatments to 200 patients battling LEMS, as BioSpace reported in 2016. Jacobus offset giving away the treatment with other drugs it manufactures. Through the compassionate use program, Jacobus was able to sidestep some of the regulatory hurdles associated with marketing a drug. The FDA’s compassionate use program allowed patient access to the Jacobus drug outside of clinical testing, despite the fact it had not been approved by the regulatory agency.
Sanders said the price that Catalyst is charging for Firdapse has many patients worried they will not be able to afford the FDA-approved Firdapse. On his Senate website, Sanders included video of a conversation he had with a LEMS patient, Rebecca Hovde of Wellman, Iowa, who expressed great concern with the price. Hovde told Sanders that when people are unable to continue to use the Jacobus product, they will “just go to bed.”
Sanders called the $375,000 price tag for Firdapse exploitative. He questioned how many patients will suffer or die due to the cost of the drug.
“By setting such a high price and forcing production and distribution of the older, inexpensive version to cease, you are threatening access that patients had to a cheap version of this product, and handing a completely unwarranted bill to American taxpayers,” Sanders wrote in the letter to Catalyst.
A harsh critic of drug prices, Sanders has used the bully pulpit to take on multiple companies over pricing. In 2017, he chastised Illinois-based Marathon Pharmaceuticals over the pricing of its treatment for patients with Duchenne muscular dystrophy. Earlier that year, Sanders called out Ariad Pharmaceuticals for systematically increasing the price of its leukemia drug, Iclusig, more than 73 percent since the drug’s launch in 2012.
The price of pharmaceuticals is a particularly hot topic now on Capitol Hill, as lawmakers are closely examining the way companies and the insurers set prices. Hearings have been held in both the Senate and House of Representatives and last week, HHS Secretary Alex Azar floated a proposal that could change the way drug rebates are offered in order to benefit consumers.
In the letter to Catalyst, Sanders requested information on what the company is charging patients, private insurers and government payers for the medication.
“The egregious price set by Catalyst cannot be allowed to stand. Patients in America should not be allowed to suffer or die because of the greed of a drug company. If Catalyst does not substantially lower the price of this medication, Congress must act to ensure it is affordable for every patient,” Sanders said.
Catalyst has not responded to Sanders, according to reports. Shares of Catalyst fell nearly 6 percent Monday to $2.37 per share on news of Sanders’ letter. The stock is down slightly in premarket trading this morning.
