Catalyst’s Revenue From Firdapse Tops $50M in 3rd Quarter 2022

Firdapse boosts chemical signals from nerves to muscle cells, helping to ease muscle weakness

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Catalyst Pharmaceuticals earned $57.2 million in the third quarter of 2022 from sales of Firdapse (amifampridine), its treatment for Lambert-Eaton myasthenia syndrome (LEMS).

According to Catalyst, this represents an all-time high net revenue from Firdapse, a 59.3% year-over-year increase and a gain of 7.8% compared with the second quarter of the year.

“Catalyst delivered another solid quarter driven by record net revenues that exceeded expectations, marking this as another strong quarter of sequential growth of our Firdapse brand. These results reflect our exceptional commercial execution and continued commitment to the patient community that we serve,” Patrick McEnany, chairman and CEO of Catalyst, said in a press release. “During the quarter, our priorities continued to be focused on commercial execution, preparing for the launch of our thoracic oncology programs to reach small-cell lung cancer patients with LEMS and diversifying our product portfolio with the acquisition of innovative therapies that address unmet medical needs in rare diseases.”

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Firdapse works by boosting the strength of the chemical signals sent from nerves to muscle cells, thereby helping to ease muscle weakness and other symptoms of LEMS. The U.S. Food and Drug Administration (FDA) recently extended its approval to cover LEMS patients as young as six.

“Moving ahead, we are well positioned to continue to drive organic growth as we look to strengthen our business with strategic opportunities that translate into added long-term value creation for all of our stakeholders,” McEnany said.

The active agent in Firdapse, called amifampridine, was also the active ingredient in the LEMS treatment Ruzurgi, which was developed by Jacobus Pharmaceutical.

The FDA approved Ruzurgi to treat children with LEMS, but Catalyst sued, alleging the approval infringed on the market exclusivity rights Catalyst had been granted developing Firdapse. Courts ultimately sided with Catalyst, invalidating Ruzurgi‘s approval.

The three-year U.S. court battle ended this year when Catalyst acquired the rights to Ruzurgi from Jacobus.

Catalyst also was recently named BioFlorida’s David J. Gury Company of the Year.

“Coupled with sustained organic growth, several significant milestones were achieved during the quarter that further enhance the commercial runway and long-term growth potential for Firdapse,” McEnany said. “The extraordinary execution across all segments of our business underscores our core competencies and adds further confidence that we are on the right path to achieving our long-term goals.”