Catalyst tries to mitigate approval of Jacobus’ LEMS treatment drug.
Canadian drug company Catalyst Pharmaceuticals (CPRX) has filed a court motion attempting to block rival Jacobus Pharmaceuticals from introducing a treatment solution for a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome (LEMS). In July, Health Canada endorsed the use of the Jacobus’ drug, but Catalyst claims the move was “incorrect and unreasonable because the regulator should not have referenced its drug in a compliance notice due to data protection.” The company wants to delay approval for its competitor’s option to August 2028.
“We think perhaps the FDA was improperly influenced by political pressure regarding high drug prices and we also feel that this is a horrible precedent for companies that are developing drugs to treat rare diseases,” Catalyst Chief Executive Officer Patrick McEnany said. “Innovative drugs, not previously approved in Canada, go through a rigorous drug approval process in Canada. A sponsor must submit clinical and nonclinical safety, tolerability, and efficacy data, to demonstrate the safety and efficacy of the drug. In exchange for that effort, and as an incentive to do that, Health Canada regulations are supposed to prevent other pharmaceutical companies from being able to use the innovator’s data as a basis for approval for eight years from the date of the Notice of Compliance. In (our) case, Health Canada only did so for ten days.”
Catalyst filed a lawsuit in 2019 against the Food and Drug Administration (FDA) for approving Jacobus’ Ruzurgi. Catalyst claimed the federal agency violated the law, because the approval “unfairly encroached on seven years of market exclusivity” it garnered for its own drug, Firdapse. A magistrate judge recommended dismissing the suit.
Jacobus had distributed Ruzurgi for free for years under an FDA compassionate use program sanction, while Catalyst charged $375,000 after securing FDA approval in 2018. When Catalyst was approved, Jacobus could no longer market its version. Catalyst offered assistance programs that significantly reduced patient costs, but public and private payers have to front the difference. At the same time, many doctors and patients have voiced concerns over the ineffectiveness of Firdapse.
Catalyst’s drug was approved by the regulator for adults, while the Jacobus drug was approved for kids ages 6 to 17. McEnany said, “If it is used according to label, which is for pediatric patients, it won’t affect our market at all.” However, approval of both meant physicians could opt to prescribe either to any of their patients. Physicians have a right to prescribe a treatment option they believe will be most effective.
Catalyst alleged the FDA “arbitrarily and capriciously approved” Ruzurgi, and the agency unfairly threatened its “right to marketing exclusivity. As a result, the FDA may hinder [the company’s] ability to recoup its $100 million investment.” Ruzurgi costs less than half of Firdapse.
Express Scripts has already announced it will favor Jacobus’ version over Catalyst’s. Others are likely to follow suit, favoring the less expensive option and choosing to carry only one version for all populations.