Bausch Health, Canada Inc. Treatment for Acne Vulgaris, (Pr)CABTREO(TM) (clindamycin phosphate, adapalene and benzoyl peroxide gel), Now Available Through Public Drug Plans of Ontario, Quebec and Two Federal Programs

Rhea-AI Summary

Bausch Health Canada (NYSE:BHC) announced that its acne treatment CABTREO is now available through public drug plans in Ontario and Nova Scotia, as well as federal programs NIHB and CSC. CABTREO is a first-of-its-kind triple-combination topical treatment for acne vulgaris in patients 12 years and older.

The prescription gel combines three mechanisms of action: an antibiotic (clindamycin phosphate), a retinoid (adapalene), and an antibacterial agent (benzoyl peroxide). The treatment is administered once daily to affected skin areas and has already been available through most private drug insurance plans.

Positive

• First and only triple-combination topical acne treatment approved by Health Canada
• Expanded market access through major public drug plans in Ontario and Nova Scotia
• Additional coverage through federal programs NIHB and CSC
• Already available through most private drug insurance plans

Negative

• Coverage not yet available in all Canadian provinces
• Prescription-only availability may limit accessibility

Insights

Pharmaceutical Industry Analyst

Bausch Health's CABTREO acne treatment now covered by major public drug plans, expanding market access for this novel triple-combination therapy.

Bausch Health has secured an important market access win with CABTREO, their novel triple-combination acne treatment. The product is now accessible through Ontario and Nova Scotia provincial drug plans, plus two federal programs: the Non-Insured Health Benefits (NIHB) for Indigenous populations and the Correctional Service of Canada (CSC) plan.

This represents a significant expansion in patient access. The reimbursement approvals from these major public payers will complement CABTREO's existing coverage on "most private drug insurance plans" according to the company, creating a more comprehensive market reach for this differentiated product.

What makes CABTREO noteworthy is its first-in-class triple-combination status in Canada, combining clindamycin phosphate (1.2%), adapalene (0.15%), and benzoyl peroxide (3.1%). This creates three distinct mechanisms of action - antibiotic, retinoid, and antibacterial - integrated into a once-daily topical gel for patients 12 and older.

For Bausch Health, this regulatory milestone likely carries revenue implications. While no specific sales projections were provided, expanding public payer coverage significantly increases the addressable patient population. The company's statement about working toward "completing listing arrangements... with other public drug plans across Canada" signals their strategic focus on maximizing CABTREO's market penetration through continued reimbursement negotiations.

The endorsement from the Acne and Rosacea Society of Canada adds clinical credibility to the listing decisions, highlighting the medical importance of diverse treatment options for a condition with both physical and psychological impacts.

LAVAL, QC / ACCESS Newswire / July 9, 2025 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced that ^PrCABTREO^TM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,¹ is now available to beneficiaries of the public drug plans of Ontario and Nova Scotia as well as through the federal government's Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations and that of the Correctional Service of Canada (CSC).

CABTREO is a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. 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

"It is very encouraging for people with acne vulgaris who use the Ontario, Nova Scotia and federal drug plans to now have access to CABTREO along with those on most private drug insurance plans," said Amy Cairns, General Manager, Bausch Health, Canada Inc. "We look forward to completing listing arrangements in the near future with other public drug plans across Canada."

"We are pleased that public drug plans are ensuring Canadians with acne have access to new treatments, recognizing the importance of making different options available," said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. "Acne can significantly impact a person's mental and physical health, so this is a big win for the patient community."

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 ARAZLO^TM (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 in adults; 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 care 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 about Bausch Health, 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 at 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%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024.

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/.

Investor Contact: Garen Sarafian ir@bauschhealth.com (877) 281-6642 (toll free)

Media Contact: Katie Savastano corporate.communications@bauschhealth.com (908) 569-3692

SOURCE: Bausch Health Companies Inc.

View the original press release on ACCESS Newswire

FAQ

What is Bausch Health's CABTREO and what is it used for?

CABTREO is a triple-combination topical prescription gel containing clindamycin phosphate, adapalene, and benzoyl peroxide, approved for treating acne vulgaris in patients 12 years and older.

Which public drug plans now cover Bausch Health's CABTREO treatment?

CABTREO is now covered by Ontario and Nova Scotia public drug plans, as well as the federal Non-Insured Health Benefits (NIHB) for Indigenous populations and Correctional Service of Canada (CSC) programs.

How is BHC's CABTREO administered to patients?

CABTREO is a topical gel that is administered once daily to affected areas of the skin.

What makes CABTREO unique in the acne treatment market?

CABTREO is the first and only Health Canada-approved triple-combination topical treatment for acne that combines three mechanisms of action: an antibiotic, a retinoid, and an antibacterial agent.

Who is eligible for CABTREO treatment under the new coverage?

Patients aged 12 years and older with acne vulgaris who are beneficiaries of Ontario, Nova Scotia public drug plans, NIHB, CSC, or most private insurance plans can access CABTREO with a prescription.