On September 23, 2021 Endo International plc (NASDAQ: ENDP) reported that its subsidiary Endo Ventures Limited has entered into definitive agreements with SK Biopharmaceuticals for the development, registration, supply, commercialization and distribution of cenobamate on an exclusive basis in Canada (Press release, SK biopharmaceuticals, DEC 23, 2021, View Source [SID1234597672]). Paladin Labs Inc., an operating company of Endo, will be responsible for all commercial activities in Canada related to cenobamate.
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"We are very pleased to work with SK Biopharmaceuticals to possibly bring a new treatment option to the market for appropriate Canadian epilepsy patients," said Livio Di Francesco, Vice President and General Manager of Paladin. "This transaction continues to build our neurology franchise. Cenobamate has shown promising clinical evidence to address an unmet need and it has the potential to become a very important addition to our existing Canadian portfolio."
Cenobamate is a novel small molecule with a dual mechanism of action under investigation for treating seizures; it is not approved in Canada. 1, 2,3 Although its precise mechanism of action is unknown, cenobamate, at clinically relevant concentrations, acts both as a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel and inhibits voltage-gated sodium currents.2,3 Long-term data of cenobamate is being studied in the open-label extensions of the double-blind placebo control trials as well as the open-label safety study in adults with uncontrolled focal-onset seizures.4 Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).5
About Cenobamate
Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is an anti-seizure medication for the treatment of partial-onset seizures in adults (also known as focal-onset seizures). In November 2019, the U.S. Food and Drug Administration approved cenobamate tablets, marketed under the trademark XCOPRI (cenobamate tablets) CV in the U.S., for such treatment. In March 2021, the European Commission granted marketing authorization for cenobamate tablets, marketed under the trademark ONTOZRY in Europe, for such treatment.