In May 2019, the FDA approved a New Drug Application (NDA) filed by Jacobus Pharmaceutical Company, Inc. (“Jacobus”) for Ruzurgi
®
, another formulation of amifampridine
(3,4-DAP),
for the treatment of pediatric LEMS patients (ages 6 to under 17). As a result of the approval of Ruzurgi
®
, based on the Company’s belief that the approval violated its statutory rights to exclusivity under the Orphan Drug Act, in June 2019 the Company filed suit against the FDA in the U.S. District Court for the Southern District of Florida challenging this approval, and Jacobus intervened in the case. While the District Court granted summary judgement in favor of the FDA and Jacobus in 2020, on September 30, 2021, a three-judge panel of 11
th
Circuit judges issued a unanimous decision overturning the District Court’s decision. The appellate court adopted our argument that the FDA’s approval of Ruzurgi
®
violated the Company’s rights to Orphan Drug Exclusivity. In November 2021, Jacobus filed a motion seeking rehearing of the decision from the full 11
th
Circuit, which motion was denied in January 2022. Further, in January 2022, Jacobus filed motions with both the 11
th
Circuit and the U.S. Supreme Court seeking a stay of the 11
th
Circuit’s ruling indicating that it would seek a review of the 11
th
Circuit’s decision from the U.S. Supreme Court. Both stay motions were denied, and on January 31, 2022, the U.S. District Court for the Southern District of Florida, based on a mandate issued by the 11
th
Circuit, entered summary judgement in the Company’s favor. On February 1, 2022, the FDA informed Jacobus that, consistent with the Court of Appeals for the Eleventh Circuit’s September 30, 2021 decision in favor of Catalyst, the final approval of the Ruzurgi
®
NDA was switched to a tentative approval until the
7-year
orphan-drug exclusivity (ODE) for FIRDAPSE
®
has expired.