Catalyst looking to expand access to Firdapse in Asia in 2023

First efforts to improve LEMS therapy availability to focus on Japan

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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In 2023, Catalyst Pharmaceuticals will be working to expand the availability of its Lambert-Eaton myasthenic syndrome (LEMS) treatment Firdapse (amifampridine) to Asian countries.

The company will first focus its efforts in Japan, where its partner DyDo Pharma is now conducting a Phase 3 clinical trial testing Firdapse in LEMS patients.

Firdapse is the only oral therapy approved in the U.S. as a symptomatic treatment for LEMS. It works to improve muscle strength and mobility in adults and children with the autoimmune disease.

“The Catalyst team is incredibly proud of what we accomplished in 2022 and excited about the prospects for the year ahead,” Patrick J. McEnany, chairman and CEO of Catalyst, said in a press release.

“We expect to continue to deliver a sustained performance in 2023 and anticipate a meaningful increase in revenues as we build upon our momentum to maximize value for all our stakeholders,” McEnany added.

Catalyst’s net revenues in the fourth quarter of 2022 were estimated at $61 million, bringing the company’s total 2022 revenue to $214 million — a 52% year-over-year increase compared with the $141 million revenue of 2021.

In 2023, Catalyst estimates that it will earn $245 to $255 million in sales from Firdapse, as well as about $130 million from sales of the approved epilepsy medication Fycompa (perampanel). Catalyst acquired U.S. rights to Fycompa from its former developer Eisai in late 2022.

“We look forward to welcoming and onboarding to the Catalyst team many of the Eisai employees responsible for the success of the Fycompa epilepsy program. In doing so, we remain dedicated to serving our patient communities and enhancing access, as we leverage our proven competencies and our expanded U.S. presence in neuroscience,” McEnany said.

The company also is hoping to increase U.S. Firdapse revenue in 2023 via greater awareness and education among patients and healthcare providers. In particular, Catalyst is focused on patients with lung cancer, given that LEMS often develops in people with cancers.

Catalyst also is reaffirming its commitment to its patient support programs in the U.S. These programs work to help people with LEMS to access Firdapse; similar programs are in place for Fycompa.

“We entered 2023 well positioned to capitalize on our expanded product portfolio, with a clear objective to fuel the continued growth of our highly complementary products, Firdapse and Fycompa,” McEnany said.

Another goal for Catalyst in the new year is to continue defending its intellectual property rights. Catalyst has waged court battles over rights to Firdapse in the past, and most recently announced its intent to fight a bid by Teva Pharmaceuticals to produce and sell a generic version of the medicine.