Italian pharma gets LEMS drug Firdapse, enters US market in $4B deal

Angelini to acquire Catalyst, aims to become 'global player' in rare disease

Written by Marisa Wexler, MS |

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Angelini Pharma, a privately-owned company based in Italy, has struck a deal — worth more than $4 billion — to acquire Catalyst Pharmaceuticals, the seller of Firdapse (amifampridine), the only approved oral therapy for Lambert-Eaton myasthenic syndrome (LEMS).

The acquisition sets up the Italian pharmaceutical for entry into the U.S. market, with the sale expected to close by the end of September, according to a joint press release from the two companies.

“Today, we take [a] significant step with the acquisition of Catalyst Pharmaceuticals, which we believe will establish Angelini Pharma as a relevant global player in neurological Rare Diseases,” said Sergio Marullo di Condojanni, CEO of Angelini.

The company will buy all shares of Catalyst‘s stock for $31.50 per share, with a total value estimated at $4.1 billion. After the merger, Catalyst will become a fully owned subsidiary of Angelini. This will mark the first time Angelini will sell medications in the U.S., according to the company.

“Entering the U.S. market will allow us to acquire the scale and capabilities needed to continue this journey,” di Condojanni said. “Patient care remains at the heart of our vision. We continue to look ahead with determination, backed by a clear strategy and the drive to keep growing on a global scale.”

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An autoimmune disease, LEMS is marked by muscle weakness caused by self-reactive antibodies that prevent nerve cells from properly sending signals to muscle cells. Firdapse is a small molecule that works to boost the strength of nerve signals, thereby improving muscle strength and easing LEMS symptoms.

The therapy has been approved in the U.S. since 2018, and is now indicated for use by LEMS patients ages 6 and older. Approvals for similar indications were also obtained in Europe, Canada, and Japan.

Firdapse was originally developed by Biomarin Pharmaceutical, but Catalyst has owned its marketing rights in North America for more than a decade. Catalyst also owns rights to develop and market Firdapse in other markets, including parts of Asia and South America.

Catalyst CEO noted ‘incredible foundation’ built by team

Rich Daly, president and CEO of Catalyst, said that the acquisition will merge Catalyst’s rare disease expertise with Angilini’s global marketing reach. In so doing, “we will create a stronger, scalable, and robust rare disease platform to expand access to life-changing therapies worldwide,” Daly said.

“This is a pivotal and transformative moment for Catalyst, our team, and the patients we serve,” Daly added. “We are proud of the incredible foundation our team has built and are confident that together with Angelini, we can enhance patient support, accelerate innovation, and continue to drive sustainable long-term value for all stakeholders.”

The acquisition by Angilini will be subject to regulatory approval and other customary conditions.

Catalyst also announced it has entered a settlement to resolve a legal dispute with Hetero USA, which had sought to bring a generic version of Firdapse to the U.S. market before Catalyst’s patents on the drug had expired.