Latest news with #pCPA
Cision Canada
07-08-2025
- Health
- Cision Canada
Alexion, AstraZeneca Rare Disease reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for Ultomiris for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) and adults with generalized myasthenia gravis (gMG) Français
The agreement is a critical step in ensuring adult patients living with NMOSD and gMG have public access to Ultomiris MISSISSAUGA, ON, Aug. 7, 2025 /CNW/ - Alexion Pharma Canada Corp., AstraZeneca's Rare Disease group, has entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for Ultomiris (ravulizumab) for the treatment of adult patients with anti-aquaporin 4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) and adult patients with anti-acetylcholine receptor (AChR) antibody-positive (Ab+) generalized myasthenia gravis (gMG). With the agreement in place with the pCPA, individual provinces and territories may now initiate the process to list Ultomiris on their formularies, the timing of which will vary by province and territory. NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves. 1-4 Most people living with NMOSD experience unpredictable relapses, characterised by a new onset of neurologic symptoms or worsening of existing neurologic symptoms, which tend to be severe and recurrent and may result in permanent disability. 4,5 gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. 6 Those living with gMG may initially experience slurred speech, double vision, droopy eyelids and weakness, with symptoms becoming more severe as the disease progresses, including extreme fatigue, difficulty swallowing, choking and respiratory failure. 7-8 "NMOSD is a rare neurological disease characterized by severe relapses that have significant impact on patients' lives. In the pivotal trial for Ultomiris (ravulizumab), all Ultomiris -treated patients remained adjudicated relapse free at Week 72. This was achieved with a much-improved delivery regimen every 2 months compared to Soliris (eculizumab) that is dosed every 2 weeks. This agreement with the pCPA is a huge step forward to providing patients access to this treatment and improving treatment of NMOSD in Canada," said Mark S. Freedman, HBSc, MSc, MD, CSPQ, FANA, FAAN, FRCPC, Professor of Medicine (Neurology), The Ottawa Hospital. "Ensuring NMOSD patients have access to therapies proven highly effective is a top priority for The Sumaira Foundation globally. Since establishing TSF Canada in 2021, we have been supporting efforts to make these therapies available to Canadian patients as well. We are therefore very pleased to hear the news that ravulizumab is now becoming accessible to AQP4+ NMOSD patients in Canada. Congratulations to all stakeholders for their tireless efforts to make this possible, including the pan-Canadian Pharmaceutical Alliance (pCPA), Alexion Canada and of course, the patients and advocates who supported this important initiative," said Sumaira Ahmed, Executive Director and Founder, The Sumaira Foundation. "The recent pCPA decision marks a key milestone in access to ravulizumab, offering patients with generalized myasthenia gravis a targeted, evidence-based biologic therapy. This agreement advances the treatment landscape and reflects a commitment to improving outcomes and quality of life for those affected by this chronic neuromuscular disorder," said Hans Katzberg, MD, MSc, FRCPC, FAAN, Professor of Medicine, University of Toronto. "Reaching this agreement is an important milestone in addressing the treatment gap for individuals with generalized myasthenia gravis. We look forward to seeing public drug programs list Ultomiris quickly and equitably across the country. It's critical that our health systems reflect fairness and urgency in responding to the needs of those with rare diseases like MG," said Dr. Homira Osman, Vice President of Research & Public Policy, Muscular Dystrophy Canada. "We would like to thank the pCPA for its partnership in recognizing the need for this important innovation for Canadians living with NMOSD and gMG. We look forward to our ongoing collaboration with provincial and territorial jurisdictions to finalize listing agreements and secure public reimbursement for patients and their caregivers," said Karen Heim, Vice President and General Manager of Alexion Canada. NMOSD NMOSD is a rare disease in which the immune system is inappropriately activated to target healthy tissues and cells in the CNS. 1 Approximately three-quarters of people with NMOSD are anti-AQP4 Ab+, meaning they produce antibodies that bind to a specific protein, aquaporin-4 (AQP4). 2-4 This binding can inappropriately activate the complement system, which is part of the immune system and is essential to the body's defence against infection, to destroy cells in the optic nerve, spinal cord and brain. 2-4 It most commonly affects women and begins in the mid-30s. Men and children may also develop NMOSD, but it is even more rare. 9-12 People with NMOSD may experience vision problems, intense pain, loss of bladder/bowel function, abnormal skin sensations (e.g., tingling, prickling or sensitivity to heat/cold) and impact on coordination and/or movement. 5 Most people living with NMOSD experience unpredictable relapses, also known as attacks. Each relapse can result in cumulative disability including vision loss, paralysis and sometimes premature death. 4,5 NMOSD is a distinct disease from other CNS diseases, including multiple sclerosis. 13 The journey to diagnosis can be long, with the disease sometimes misdiagnosed. 1 gMG gMG is a rare autoimmune disorder characterised by loss of muscle function and severe muscle weakness. 6 Eighty-five percent of people with gMG are AChR antibody-positive meaning they produce specific antibodies (anti-AChR) that bind to signal receptors at the neuromuscular junction (NMJ), the connection point between nerve cells and the muscles they control. 14 This binding activates the complement system, causing the immune system to attack the NMJ leading to inflammation and a breakdown in communication between the brain and the muscles. 15 gMG can occur at any age, but it most commonly begins for women before the age of 40 and for men after the age of 60. 16 Initial symptoms may include slurred speech, double vision, droopy eyelids and lack of balance; these can often lead to more severe symptoms as the disease progresses such as impaired swallowing, choking, extreme fatigue and respiratory failure. 7,8 Ultomiris Ultomiris (ravulizumab), the longest-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body's immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells. Following a loading dose, Ultomiris is administered intravenously every eight weeks in adults, or every four or eight weeks in paediatric patients (based on body weight). Ultomiris is approved in the US, EU, Japan and other countries for the treatment of certain adults with paroxysmal nocturnal haemoglobinuria (PNH) and for certain children with PNH in the US and EU. Ultomiris is also approved in the US, EU, Japan and other countries for the treatment of certain adults and children with atypical haemolytic uraemic syndrome (aHUS). Additionally, Ultomiris is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with generalised myasthenia gravis (gMG). Further, Ultomiris is approved in the US, EU, Japan and other countries for the treatment of certain adults with neuromyelitis optica spectrum disorder (NMOSD). Ultomiris is being assessed as a treatment for additional indications as part of a broad development programme. Alexion Alexion, AstraZeneca Rare Disease is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US. For more information, please visit AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit and follow the Company on social media @AstraZeneca. References Jarius S, et al. The History of Neuromyelitis Optica. J Neuroinflammation. 2013;10:8. Hamid SHM, et al. What proportion of AQP4-IgG-negative NMO spectrum disorder patients are MOG-IgG positive? A cross sectional study of 132 patients. J Neurol. 2017;264(10):2088-2094. Yick LW, et al. Aquaporin-4 Autoantibodies From Neuromyelitis Optica Spectrum Disorder Patients Induce Complement-Independent Immunopathologies in Mice. Front. Immunol. 2018;9:1438. Wingerchuk DM, et al. The spectrum of neuromyelitis optica. Lancet Neurol. 2007;6(9):805-815. Mutch K, et al. Life on Hold: The Experience of Living with Neuromyelitis Optica. Disabil Rehabil. 2014:36(13):1100-1107. Jung-Plath W, et al. Assessment of myasthenia gravis patients' quality of life. The Journal of Neurological and Neurosurgical Nursing. 2023;12(2):74-83. Catalin J, et al. Clinical presentation of myasthenia gravis. Thymus. 2019. Farid ZR, et al. Factors affecting generalization of ocular myasthenia gravis. Sriwijaya Journal of Ophthalmology. 2020;3(2):48-54. Bukhari W, et al. Incidence and Prevalence of NMOSD in Australia and New Zealand. J Neurol Neurosurg Psychiatry. 2017:88(8):632-638. Wingerchuk DM, et al. Revised diagnostic criteria for neuromyelitis optica. Neurology. 2006;66(10):1485–1489. Drori T, et al. Diagnosis and classification of neuromyelitis optica (Devic's syndrome). Autoimmunity Reviews. 2014;13(4-5):531–533. Eaneff S, et al. Patient perspectives on neuromyelitis optica spectrum disorders: Data from the PatientsLikeMe online community. Multiple Sclerosis and Related Disorders. 2017;17:116–122. Mealy MA, et al. Assessment of Patients with Neuromyelitis Optica Spectrum Disorder Using the EQ-5D. Int J MS care. 2019;21(3):129–134. Lazaridis K, et al. Myasthenia gravis: autoantibody specificities and their role in MG management. Front Neurol. 2020;11:596981. Huang YF, et al. Visualization and characterization of complement activation in acetylcholine receptor antibody seropositive myasthenia gravis. Muscle Nerve. 2024; 70(4):851-861. Cavanagh N, et al. Exploring the impairments and allied health professional utilization in people with myasthenia gravis: a cross-sectional study. J Clin Neurosci. 2023;114:9-16.
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.
