Bausch's Cabtreo acne drug on two provincial drug plans

Ms. Amy Cairns reports BAUSCH HEALTH, CANADA INC. TREATMENT FOR ACNE VULGARIS, (PR)CABTREO (CLINDAMYCIN PHOSPHATE, ADAPALENE AND BENZOYL PEROXIDE GEL), NOW AVAILABLE THROUGH PUBLIC DRUG PLANS OF QUEBEC AND SASKATCHEWAN Bausch Health Companies Inc.'s Bausch Health, Canada Inc. has made available Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2 per cent w/w, 0.15 per cent w/w and 3.1 per cent w/w, for the treatment of acne vulgaris to beneficiaries of the public drug plans of Quebec and Saskatchewan. This new public drug plan availability of Cabtreo is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government's Non-Insured Health Benefits (NIHB) drug plan for indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada. Cabtreo is a new Canadian-made 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. "The addition of Cabtreo to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment -- joining those already covered under most private insurance plans," said Amy Cairns, general manager, Bausch Health Canada. "Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage." 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. 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. It can also cause skin pigmentation changes. 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 end points, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count and percentage of patients achieving predefined treatment success. Combined efficacy results for both trials for Cabtreo achieved approximately 50-per-cent treatment success and a greater than 70-per-cent reduction in both inflammatory and non-inflammatory lesions at week 12. 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. 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. 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 (tazarotene lotion, 0.045 per cent w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; Bryhali (halobetasol propionate lotion 0.01 per cent w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and Duobrii (0.01 per cent w/w halobetasol propionate and 0.045 per cent 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, Que., facility for Canada and the United States. About Bausch Health Companies Inc. Bausch Health Companies is a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health care outcomes. It develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through a controlling interest in Bausch + Lomb Corp. We seek Safe Harbor.