Catalyst Gets US Rights to Ruzurgi in Patent Settlement With Jacobus

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by Marisa Wexler, MS |

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In a deal that ends a three-year U.S. court battle over patent infringement claims for Lambert-Eaton myasthenic syndrome (LEMS) medications, Catalyst Pharmaceuticals will acquire the rights to the LEMS therapy Ruzurgi.

Catalyst announced it has reached a settlement with Jacobus Pharmaceutical and PANTHERx Rare on its patent infringement litigation regarding Firdapse, the first therapy approved for treating LEMS.

As part of the settlement, Catalyst will dismiss all further legal claims related to patent issues between the companies. Catalyst also will acquire certain of Jacobus’ intellectual property rights, including the rights to develop and commercialize Ruzurgi in the U.S. and Mexico.

“We are pleased to have reached a mutually agreeable resolution to this litigation, as it removes any further litigation costs and related distractions for Catalyst,” Patrick McEnany, chairman and CEO of Catalyst, said in a press release.

“Having achieved this meaningful milestone, the plan is to address our ongoing focus on patient’s needs by continuing to supply those patients with other neuromuscular conditions currently being treated with Ruzurgi under investigator-sponsored INDs [investigational new drug applications]. At the same time, we will also continue to concentrate our resources on addressing the needs of the LEMS patient community while further evaluating other rare disease opportunities,” McEnany added.

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Catalyst markets Firdapse, which was approved by the U.S. Food and Drug Administration (FDA) in 2018 to treat LEMS patients, ages 17 and older. The active agent in Firdapse, called amifampridine, helps boost the strength of signals sent from nerve to muscle cells by modulating the activity of proteins found on nerve cells called voltage-dependent potassium channels.

Ruzurgi, developed by Jacobus, contains the same active ingredient as Firdapse. The FDA originally approved Ruzurgi in 2019 as the first therapy for children, ages 6–17, with LEMS.

Catalyst challenged that FDA approval in court. In its lawsuit, the company alleged that the approval violated its rights to market exclusivity for Firdapse, which Catalyst had been granted after its therapy received an FDA orphan drug designation.

A federal appeals court ultimately sided with Catalyst, and the FDA’s approval of Ruzurgi was vacated early this year. Catalyst announced plans to ask the FDA to expand Firdapse’s approval to cover children with LEMS shortly after that decision was announced.

As part of the settlement, Jacobus has agreed to dismiss legal action it had in the works to ask the U.S. Supreme Court to overturn the appeals court verdict. Catalyst also will be making a cash payment to Jacobus, and will pay Jacobus a small royalty on its sales of amifampridine in the U.S.

In its original suit, Catalyst also had named PANTHERx, the specialty pharmacy that was distributing Ruzurgi.

According to McEnany, this settlement “underscores the strength of the Firdapse intellectual property portfolio.”

For its part, Jacobus said the settlement “represents the opportunity to build upon our accomplishments to further serve our patients,” according to Laura R. Jacobus, the company’s president.

“Our mission has always been to bring life-changing therapies to patients and families affected by rare diseases, and we are pleased to have reached a favorable outcome with Catalyst, which shares that same commitment,” Jacobus said.