Catalyst Pharmaceuticals Files Lawsuit Against FDA Over Rival Drug

Catalyst Pharmaceuticals (NASDAQ:CPRX) is suing the US Food and Drug Administration (FDA) over the recent approval of a cheaper rival drug.

In a press release issued on Wednesday (June 11), the pharmaceutical company said that the approval of Jacobus Pharmaceutical’s drug, Ruzurgi, breaches multiple provisions of the FDA’s regulations and Catalyst’s exclusivity rights for its drug, Firdapse.

Both drugs are intended to treat lambert-eaton myasthenic syndrome (LEMS), which is an autoimmune disease that attacks the body’s own tissues. Catalyst’s Firdapse was awarded the first approval to treat LEMS in adult patients by the regulatory agency last year. Ruzurgi was approved by the FDA in May to specifically treat children with LEMS.

“We believe the FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst’s orphan drug exclusivity,” Patrick McEnany, chairman and CEO of Catalyst Pharmaceuticals, said in the press release.

Prior to the FDA’s approval of Firdapse, the drug had been available for free since the 1990s from Jacobus through the FDA’s compassionate use program, Reuters reported in February. Once Firdapse received the green light from the regulatory agency, a US$375,000 annual price tag was slapped onto the drug in December, a move that received criticism from US Senator Bernie Sanders.

“Catalyst’s decision to set the annual list price at US$375,000 is not only a blatant fleecing of American taxpayers, but is also an immoral exploitation of patients who need this medication,” Sanders said in a letter.

Sanders told Reuters in February that the company had demonstrated “blatant disregard for patients with LEMS.”

Jacobus’ Ruzurgi is priced at US$175,200 annually, which is less than half the price of Firdapse.

According to Catalyst Pharmaceuticals’ press release, it is asking the FDA to revoke approval of Ruzurgi so that the company can retain its orphan drug designation for Firdapse. Orphan drug status gives a drug market exclusivity in the US over the course of seven years for an indication.

Firdapse is commercially available in the US to treat LEMS and is the first and only approved drug in Europe for symptomatic treatment of LEMS in adult patients.

Following its announcement, Catalyst Pharmaceuticals bumped up 2.8 percent to close Wednesday’s trading session at US$3.67. After-hours trading bumped it down to US$3.65 as of 4:15 p.m. EDT.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any of the companies mentioned in this article.