SK Biopharm's 'Cenobamate' Begins Regulatory Review in Canada and Israel

SK Biopharm's epilepsy new drug 'Cenobamate (U.S. launch name 'Xcopri')'

[Asia Economy Reporter Chunhee Lee] SK Biopharm's epilepsy drug 'Cenobamate' is challenging entry into Canada and Israel.

According to SK Biopharm on the 9th, Paladin Labs, the Canadian partner, recently completed the submission of the New Drug Submission (NDS) for Cenobamate to Canada Health, the Canadian federal health department, in June, and a full review is expected to proceed.

SK Biopharm signed a license agreement last year with Endo Ventures, a subsidiary of the Irish pharmaceutical company Endo Group, to handle approval and commercialization in Canada. Currently, this is managed by Paladin Labs, a subsidiary of Endo Group. Once the NDS approval is obtained, full-scale commercialization is expected to begin. SK Biopharm is anticipated to secure milestone royalties following approval and commercialization, as well as additional profits from the supply of Cenobamate.

Additionally, the Israeli regional partner, Dexcel Pharma, recently submitted a Cenobamate approval application to the Israeli authorities and announced that the official review process has commenced. Since Israel’s approval process for new drugs already approved by the U.S. Food and Drug Administration (FDA) is relatively simple, rapid commercialization of Cenobamate in Israel is expected.