Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ: ENDP), announced today that Health Canada has accepted its New Drug Submission (NDS) for cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

A decision from Health Canada as to whether cenobamate tablets can be marketed and sold in Canada under this NDS is expected mid-2023.

'This is an important step in our journey to address the unmet needs of adult patients diagnosed with partial-onset seizures,' said Livio Di Francesco, Vice President and General Manager of Paladin. 'Paladin Labs is committed to working collaboratively with regulatory, pricing and reimbursement authorities in order to provide cenobamate to appropriate patients as quickly as possible.'

The regulatory submission includes efficacy information from two pivotal studies (C013 and C017)1,2, which enrolled a total of 658 patients. The evaluation of safety was conducted over the course of the two pivotal studies, and their respective open-label extensions, and is complemented by a long-term open-label Phase III safety study (C021)3, also presented in the regulatory submission. A total of 1,944 patients with epilepsy have been treated with cenobamate in the clinical development program.

Endo Ventures Limited, a subsidiary of Endo, and SK Biopharmaceuticals signed a licensing agreement in December 2021 granting Endo Ventures Limited the exclusive right to commercialize cenobamate in Canada. Under the terms of this agreement, Paladin Labs is responsible for all commercial activities in Canada related to cenobamate.

About Cenobamate

Cenobamate is a novel small molecule with a dual mechanism of action under investigation for treating seizures.4,5,6 Cenobamate, at clinically relevant concentrations, acts both as a positive allosteric modulator of the ?-aminobutyric acid (GABAA) ion channel and inhibits voltage-gated sodium currents.2,3 Long-term data of cenobamate has been 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 partial-onset seizures. 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).7

Cenobamate was discovered by SK Biopharmaceuticals and SK life science, and is an anti-seizure medication for the adjunctive or monotherapy 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.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI (cenobamate tablets) CV can be found on www.xcopri.com.

About Endo and Paladin Labs

Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc. For more information visit: www.endo.com or www.paladin-labs.com.

References

1. https://www.clinicaltrials.gov/ct2/show/NCT01397968

2. https://www.clinicaltrials.gov/ct2/show/NCT01866111

3. https://www.clinicaltrials.gov/ct2/show/NCT02535091

4. Guignet M, Campbell A, White HS, Epilepsia. 2020 Oct 16. doi: 10.1111/epi.16718. Online ahead of print

5. Nakamura M, et al. Eur J Pharmacol 2019;855:175-182.

6. Sharma R, et al. Eur J Pharmacol 2020;879:173117.

7. https://www.clinicaltrials.gov/ct2/show/NCT03678753

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