Despite weathering significant criticism from lawmakers and patient groups over the steep cost of its rare disease med Firdapse, Catalyst Pharmaceutical has repeatedly emerged triumphant over its detractors.
Now, the Florida-based drugmaker has parried another Firdapse challenger in Teva Pharmaceuticals, which had hoped to market a generic version of the Lambert-Eaton myasthenic syndrome (LEMS) drug before its U.S. patents run out.
Catalyst and its licensor SERB have inked a settlement with Teva to resolve patent litigation brought by Catalyst after Teva made its plans to seek approval for its generic known in early 2023.
Under the agreement, Teva is barred from marketing its Firdapse copycat in the U.S. until Feb. 25, 2035, at the earliest, Catalyst said Wednesday. Teva’s generic version of the med, amifampridine, has not yet been approved by the FDA.
Catalyst’s share price jumped more than 16% before market close Wednesday on news of the settlement.
Prior to filing its lawsuit, Catalyst in January of 2023 revealed that Teva had filed for approval of a generic version of Firdapse. Notably, the Israeli-American pharma said it planned to market its copycat before the expiration of Catalyst’s Firdapse patents in the FDA Orange Book. At the time, Teva alleged that those patents, due to run out between 2032 and 2037, were invalid and unenforceable, according to Catalyst.
Firdapse is one of three commercial products marketed by Catalyst, alongside the Duchenne muscular dystrophy med Agamree and the seizure drug Fycompa. For all of 2023, Firdapse recorded sales of $258 million, climbing nearly 21% over the sum it generated in 2022. As of 2024’s third quarter, Catalyst said it expected the therapy to reel in sales between $300 million and $310 million for the entire year.
Since licensing U.S. rights to Firdapse from BioMarin, Catalyst has been mired in controversy over the drug’s hefty price tag, which was originally set at $375,000 before discounts.
In the decades preceding Firdapse’s FDA approval, U.S. patients could access the drug for free through a compassionate use program.
Catalyst’s pricing decision quickly drew the ire of Patients for Affordable Drugs (P4AD) and Sen. Bernie Sanders, I-Vt., who deemed the sticker price a “blatant fleecing of American taxpayers.” In criticizing Firdapse’s price tag, P4AD also urged the industry group BIO to drop Catalyst as a member.
Catalyst, for its part, previously argued that Firdapse filled a large unmet need for an FDA-approved product. Prior to the green light, only about 200 of an estimated 3,000 LEMS patients in the U.S. were using the unapproved version, which was often difficult to obtain, Catalyst said in 2019.
On the heels of the pricing row, the FDA that same year approved Jacobus’ LEMS drug Ruzurgi in patients 6 to less than 17 years old. While the pediatric nod prevented Ruzurgi from competing directly with Firdapse, Oppenheimer analysts suggested Jacobus’ drug could pose an off-label threat.
Catalyst quickly took the matter to court and came out victorious in 2021 when a U.S. appeals court panel ruled that the FDA should not have approved Jacobus’ drug, calling the green light “arbitrary, capricious and not in accordance with the law.”
The FDA officially rescinded its approval of Ruzurgi in February of 2022, according to reports. The agency concluded that because Ruzurgi had the same active ingredient as Firdapse—and because LEMS manifests similarly in kids and adults—Jacobus had failed to demonstrate superiority over Firdapse or any differentiating features that would have justified the pediatric nod.
LEMS is a rare neuromuscular disorder that damages the connections between nerves and muscles. The condition can lead to death if it strikes the respiratory system. There are about 400 known cases of LEMS in the United States and some 2.8 million worldwide, according to the National Organization for Rare Disorders.