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
Bausch Health, Canada Inc. has signed a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) for public drug plan coverage of CABTREO, their triple-combination topical treatment for acne vulgaris. The agreement will enable coverage through all Canadian government drug plans, including provincial, territorial, and federal programs.
CABTREO is the first Health Canada-approved triple-combination topical acne treatment combining three mechanisms of action: an antibiotic (clindamycin phosphate), a retinoid (adapalene), and an antibacterial agent (benzoyl peroxide). The prescription gel, administered once daily, is indicated for patients 12 years and older.
Bausch Health, Canada Inc. ha firmato una lettera di intenti con il pan-Canadian Pharmaceutical Alliance (pCPA) per la copertura del piano di farmaci pubblici di CABTREO, il loro trattamento topico a tripla combinazione per l'acne vulgaris. L'accordo permetterà la copertura attraverso tutti i piani farmaceutici governativi canadesi, inclusi i programmi provinciali, territoriali e federali.
CABTREO è il primo trattamento topico per l'acne a tripla combinazione approvato da Health Canada, che combina tre meccanismi d'azione: un antibiotico (fosfato di clindamicina), un retinoide (adapalene) e un agente antibatterico (perossido di benzoile). Il gel da prescrizione, somministrato una volta al giorno, è indicato per pazienti di 12 anni e oltre.
Bausch Health, Canada Inc. ha firmado una carta de intención con la Alianza Farmacéutica Pan-Canadiense (pCPA) para la cobertura del plan de medicamentos públicos de CABTREO, su tratamiento tópico de triple combinación para el acné vulgar. El acuerdo permitirá la cobertura a través de todos los planes de medicamentos gubernamentales canadienses, incluidos los programas provinciales, territoriales y federales.
CABTREO es el primer tratamiento tópico de triple combinación aprobado por Health Canada que combina tres mecanismos de acción: un antibiótico (fosfato de clindamicina), un retinoide (adapaleno) y un agente antibacteriano (peróxido de benzoilo). El gel recetado, administrado una vez al día, está indicado para pacientes de 12 años o más.
바우쉬 헬스, 캐나다 주식회사는 범캐나다 제약 동맹(pCPA)와 CABTREO의 공공 약물 계획 보장을 위한 의향서를 체결했습니다. 이는 그들의 여드름 치료를 위한 삼중 조합의 국소 치료제입니다. 이 계약은 모든 캐나다 정부 약물 계획을 통해 보장을 가능하게 하며, 주, 준주 및 연방 프로그램을 포함합니다.
CABTREO는 세 가지 작용 메커니즘을 결합한 Health Canada 승인을 받은 첫 번째 삼중 조합 국소 여드름 치료제입니다: 항생제(클린다마이신 인산염), 레티노이드(아다팔렌), 항균제(벤조일 과산화물). 처방 젤은 하루 한 번 투여되며, 12세 이상의 환자에게 적합합니다.
Bausch Health, Canada Inc. a signé une lettre d'intention avec l'Alliance pharmaceutique pan-canadienne (pCPA) pour la couverture du plan de médicaments publics de CABTREO, leur traitement topique à triple combinaison pour l'acné vulgaire. Cet accord permettra la couverture à travers tous les régimes de médicaments gouvernementaux canadiens, y compris les programmes provinciaux, territoriaux et fédéraux.
CABTREO est le premier traitement topique à triple combinaison approuvé par Santé Canada, combinant trois mécanismes d'action : un antibiotique (phosphate de clindamycine), un rétinoïde (adapalène) et un agent antibactérien (peroxyde de benzoyle). Le gel sur prescription, administré une fois par jour, est indiqué pour les patients âgés de 12 ans et plus.
Bausch Health, Canada Inc. hat ein Absichtsschreiben mit der pan-kanadischen Pharma-Allianz (pCPA) zur öffentlichen Arzneimittelversorgung von CABTREO, ihrer topischen Dreifachkombination zur Behandlung von Akne vulgaris, unterzeichnet. Die Vereinbarung ermöglicht die Abdeckung durch alle kanadischen staatlichen Arzneimittelpläne, einschließlich der provinziellen, territorialen und föderalen Programme.
CABTREO ist die erste von Health Canada genehmigte topische Aknebehandlung mit Dreifachkombination, die drei Wirkmechanismen kombiniert: ein Antibiotikum (Clindamycinphosphat), ein Retinoid (Adapalen) und ein antibakterielles Mittel (Benzoylperoxid). Das verschreibungspflichtige Gel wird einmal täglich angewendet und ist für Patienten ab 12 Jahren geeignet.
- First-to-market advantage as the only triple-combination topical acne treatment approved by Health Canada
- Secured public drug plan coverage across all Canadian government programs
- Expands market access and potential revenue through government insurance channels
- None.
Insights
Bausch Health has achieved a significant market access milestone by securing a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) for CABTREO, its triple-combination acne treatment. This agreement establishes the framework for coverage under all Canadian public drug plans - provincial, territorial, and federal programs.
The pCPA agreement represents a critical hurdle cleared in Canada's multi-step reimbursement process. Bausch must now finalize individual listing agreements with each public plan, but with standardized terms already established through the pCPA, this typically proceeds more efficiently than negotiating separately with each jurisdiction.
CABTREO's unique triple-mechanism formulation (combining an antibiotic, retinoid, and antibacterial agent) gives it a distinct competitive advantage as the first and only such combination approved in Canada. This differentiation is particularly valuable in the highly competitive dermatology space where novel formulations can drive prescription preference.
For Bausch, securing public reimbursement significantly expands the potential patient population for CABTREO beyond those with private insurance or paying out-of-pocket. While impact magnitude isn't quantifiable without knowing the pricing terms negotiated or potential prescription volumes, the development clearly strengthens Bausch's dermatology portfolio in Canada by removing a key access barrier for this differentiated product.
LAVAL, QC / ACCESS Newswire / 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
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
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,
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 www.bauschhealth.com 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 www.bauschhealth.ca.
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.
REFERENCES
1 Bausch Health, Canada Inc., CABTREO Product Monograph, https://pdf.hres.ca/dpd_pm/00076715.PDF.
2 Canadian Dermatology Association, Acne, Quick Facts, https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%
3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024.
4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.
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SOURCE: Bausch Health Companies Inc.
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FAQ
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