SK Biopharmaceuticals announced that Health Canada has accepted Paladin Labs Inc.'s filing of a New Drug Submission (NDS) for cenobamate as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. If Health Canada approves this NDS, Paladin Labs would be able to launch cenobamate in Canada.
In December 2021, SK Biopharmaceuticals entered into definitive agreements with Endo International plc (Endo)'s subsidiary, Endo Ventures Limited, to commercialize cenobamate in Canada. Under the agreements, Paladin Labs, a Canada-based operating company of Endo, is responsible for all commercial activities. SK Biopharmaceuticals will receive milestone payments for future approval and commercialization, as well as additional supply benefits as a result of these agreements.
Dexcel Pharma, an Israeli partner of SK Biopharmaceuticals, has also completed submission of its New Drug Application for cenobamate, and has received filing acceptance from the Israel Ministry of Health.