PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel) Treatment for Acne Vulgaris Receives Positive Reimbursement Recommendations from Canada's Drug Agency and Quebec's INESSS

LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE/TSX:BHC), today announced that 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 has received positive reimbursement recommendations from Canada's Drug Agency (CDA, formerly the Canadian Agency for Drugs and Technology in Health) and Quebec's Institut national d'excellence en santé et en services sociaux (INESSS).

The recommendations are an important element in the process to achieve reimbursement of a new medication by Canada's public drug plans operated by the provinces, territories and federal government. Bausch Health, Canada will now work with the pan-Canadian Pharmaceutical Alliance (pCPA) to agree on the particulars regarding the reimbursement of CABTREO by Canada's public drug plans.

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

"The positive recommendations of both CDA and INESSS are important steps in achieving the inclusion of CABTREO on Canada's public drug plans and recognize this new treatment's value in helping Canadians with acne," said Amy Cairns, General Manager, Bausch Health, Canada. "We look forward to working with the pCPA to finalize the terms of eventual drug plan listings to increase the availability of CABTREO to Canadians who might benefit from it."

"We are thrilled that Canadians with acne will soon have access to new treatment options that may improve their quality of life," said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. "Acne is a chronic skin condition and can greatly impact a person's physical, emotional and social well-being."

CABTREO 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 which has a broad-spectrum bactericidal activity.1 The prescription therapy is available now through pharmacies across Canada.

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 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 use or intravaginal use.1

About Dermatology at Bausch Health, Canada

Bausch Health, Canada 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 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 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/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, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. 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 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/.

SOURCE: Bausch Health Companies Inc.