Latest news with #pCPA
Globe and Mail
14-04-2025
- Health
- Globe and Mail
Paladin Pharma and the pan-Canadian Pharmaceutical Alliance (pCPA) Successfully Complete Negotiations for Public Funding of XCOPRI® (cenobamate tablets)
MONTREAL , /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 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: pCPA, "Xcopri (cenobamate)", available at Xcopri (cenobamate) | pCPA Accessed April 4, 2024 Canadian Epilepsy Alliance. Accessed April 4, 2024 . Public Health Agency of Canada . Epilepsy in Canada . 2021. Accessed April 4, 2025 . Epilepsy Canada . Accessed April 4, 2025 . XCOPRI ® Product Monograph. Paladin Pharma Inc. May 15, 2024 . Chung SS, et al. Neurology. 2020;94:e2311-e2322. Krauss GL, et al. Lancet Neurol. 2020;19:38-48. Sperling MR, et al. Epilepsia. 2020;61(6):1099-1108.
Associated Press
14-04-2025
- Health
- Associated Press
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 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: SOURCE Paladin Pharma Inc.
Associated Press
09-04-2025
- Health
- Associated Press
Bausch Health, Canada Inc. and the pan-Canadian Pharmaceutical Alliance Sign Letter of Intent for Public Drug Plan Coverage of (Pr)CABTREO(TM) (clindamycin phosphate, adapalene and benzoyl peroxide gel) Treatment for Acne Vulgaris
LAVAL, QC / / April 9, 2025 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced that it has signed a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) for Canadian public drug plan coverage for PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older.1 The letter of intent means Bausch Health, Canada Inc. can now proceed to finalizing individual listing agreements for CABTREO to be covered by each of Canada's government drug plans, including those of all provinces and territories and the federal government (including plans for veterans and Indigenous peoples). The letter of intent spells out the agreed terms of those listing agreements, given the participation of all Canadian public drug plans in the pCPA process. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action - an antibiotic, a retinoid and an antibacterial agent - to provide a safe and effective treatment.1 'We are very pleased to have reached agreement with the pan-Canadian Pharmaceutical Alliance on the terms that will lead to the availability of CABTREO to Canadians through the public drug plans,' said Amy Cairns, General Manager, Bausch Health, Canada Inc. 'We look forward to quickly finalizing individual listing agreements with the public drug plans.' 'It is very encouraging that a new treatment option for Canadians with acne will soon be available through their public drug plan,' said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. 'Acne can have a lifelong impact on a person's mental and physical well-being, therefore access to care is key to improved health outcomes.' CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ('vulgaris' means 'common') is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn's disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene) lotion, 0.045% w/w, for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments - CABTREO, ARAZLO, BRYHALI and DUOBRII - are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit and connect with us on LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found on the Company's website at Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words 'will,' 'anticipates,' 'hopes,' 'expects,' 'intends,' 'plans,' 'should,' 'could,' 'would,' 'may,' 'believes,' 'subject to' and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. , accessed Aug. 20, 2024. 3 'What to Know about Hyperpigmentation Acne.' Medical News Today, Jessica Caporuscio, April 28, 2021, , accessed Aug. 20, 2024. SOURCE: Bausch Health Companies Inc.
