Paladin Pharma and the pan-Canadian Pharmaceutical Alliance (pCPA) Successfully Complete Negotiations for Public Funding of XCOPRI® (cenobamate tablets)

MONTREAL, April 14, 2025 /CNW/ -- Paladin Pharma is pleased to announce the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the public funding of XCOPRI^® (cenobamate tablets) as adjunctive therapy in the management of focal seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.¹

"We are pleased to have successfully concluded the negotiation process with the pCPA," said Livio Di Francesco, Vice President & General Manager of Paladin Pharma. "This is a significant milestone to ensure that appropriate Canadian epilepsy patients have broad and equitable access to XCOPRI, and it is exciting news for the epilepsy community across Canada."

Since launch, the Paladin team has already achieved early access for XCOPRI through private payer reimbursement, with approximately 85% of privately insured lives in Canada having access to the treatment.

The next step in the public reimbursement process will be for provincial, territorial, and federal government organizations to make their respective final decisions on public reimbursement for their regions. Paladin looks forward to working with each of them to make XCOPRI available as soon as possible through public drug plans.

"We hope the jurisdictions move as quickly as possible," added Di Francesco. "Uncontrolled epilepsy can have a significant impact on a patient's life, and we look forward to the day when all appropriate patients in Canada can have access to this important treatment option."

About Epilepsy ^2-4

Epilepsy is a chronic neurological condition affecting ~300,000 Canadians. It is characterized by recurrent, unprovoked seizures. While there are many different types of seizures, they can be grouped into two broad categories – generalized seizures and focal seizures – based on where in the brain the seizure activity starts. Focal seizures (also called partial-onset seizures) affect ~60% of people with epilepsy. While many people with epilepsy respond to anti-seizure medication, ~30% of patients continue to experience seizures, despite treatment with currently available medication options.

About XCOPRI

XCOPRI received Health Canada approval in June 2023 for use as adjunctive therapy in the management of focal seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. It is taken orally, once daily.⁵

XCOPRI is a new generation of anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. It is a novel molecule with a dual mechanism of action. In pre-clinical studies, XCOPRI has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a modulator of the γ-aminobutyric acid (GABAA) ion channel.^5-6 The efficacy and safety of XCOPRI for the treatment of adults with uncontrolled partial-onset seizures (also known as focal-onset seizures) were assessed in two randomized, placebo-controlled, double-blind clinical trials (C013 and C017).^6-7 The long-term safety of cenobamate in this population has been studied in an open-label safety study (C021).⁸

During Studies C013 and C017, a total of 441 patients were exposed to XCOPRI. In both studies, the primary efficacy endpoint was median percent reduction from baseline in seizure frequency per 28 days. The key secondary endpoint was responder rates, defined as the proportion of patients with 50% or greater reduction in seizure frequency. XCOPRI significantly reduced seizure frequency and demonstrated a significantly higher ≥50% responder rate compared to placebo. In Study C013, 28.3% of patients in the cenobamate group reported being seizure free during the maintenance phase (placebo: 8.8%).

Consult the Product Monograph for complete efficacy and safety information.

Cenobamate is currently marketed in the U.S. as XCOPRI^® and in Europe under the trademark ONTOZRY^®.

About Paladin Pharma

Paladin Pharma 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, Inc. For more information visit www.paladin-pharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, the statements by Mr. Di Francesco and any statements relating to marketing approval, public funding and reimbursement, product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Paladin's or Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Paladin and Endo may not currently be able to predict. Although Paladin and Endo believe that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the public funding processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A.

References:

1. pCPA, "Xcopri (cenobamate)", available at Xcopri (cenobamate) | pCPA Accessed April 4, 2024
2. Canadian Epilepsy Alliance. https://www.canadianepilepsyalliance.org/about-epilepsy/. Accessed April 4, 2024.
3. Public Health Agency of Canada. Epilepsy in Canada. 2021. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/64-03-17-2021-Epilepsy-in-Canada-EN-FINAL.pdf. Accessed April 4, 2025.
4. Epilepsy Canada. https://www.epilepsy.ca/what-is-epilepsy. Accessed April 4, 2025.
5. XCOPRI^® Product Monograph. Paladin Pharma Inc. May 15, 2024.
6. Chung SS, et al. Neurology. 2020;94:e2311-e2322.
7. Krauss GL, et al. Lancet Neurol. 2020;19:38-48.
8. Sperling MR, et al. Epilepsia. 2020;61(6):1099-1108.

SOURCE Paladin Pharma Inc.

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