(Pr)ELIDEL® (pimecrolimus) cream Now Reimbursed Under Alberta's Public Drug Plan for Eligible Patients with Mild to Moderate Atopic Dermatitis

(Pr)ELIDEL® (pimecrolimus) cream Now Reimbursed Under Alberta's Public Drug Plan for Eligible Patients with Mild to Moderate Atopic Dermatitis

LAVAL, QC, July 28, 2026 /CNW/ -- Bausch Health, Canada Inc., a subsidiary of Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) announces that ^PrELIDEL® (pimecrolimus) cream is now listed under Alberta's public drug plan for eligible patients.

ELIDEL® cream is indicated for second-line therapy for short-term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.¹

ELIDEL® has been available by prescription in Canada since 2003. The product is already reimbursed under several public drug plans across Canada, including those in British Columbia, Saskatchewan, Ontario, and Québec. With Alberta now adding coverage, more patients will have access to this treatment option.

"We are delighted that public reimbursement in Alberta will enable more patients living with atopic dermatitis to access ELIDEL®. Improving access to treatment is critical to helping patients better manage their medical condition, while supporting improved health outcomes," said Amy Cairns, General Manager, Bausch Health, Canada Inc.

"The reimbursement of ELIDEL® in Alberta is fantastic news for patients living with atopic dermatitis," said Dr. Jessica Asgarpour, MD, FRCPC, FAAD, DABD, dermatologist at the Skin Health and Wellness Centre in Calgary, Alberta. "Greater access to a topical non-corticosteroid treatment option will help physicians tailor therapy to individual patient needs and expand treatment choices for patients seeking alternatives to topical corticosteroids."

About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing, and remitting inflammatory skin disease² commonly encountered by primary-care providers.³ It affects all ages. In infants, onset occurs most often between 3 and 6 months.² In children and teenagers, the estimated prevalence is 10 to 15%.³  About 40% of these continue to be affected as adults.³ About 85% of all patients have mild to moderate disease.³

ELIDEL® Clinical Data and Safety Information
ELIDEL® Cream should be used in accordance with the Canadian Product Monograph. Please consult the Product Monograph for complete information on indications, contraindications, warnings and precautions, adverse reactions, drug interactions, dosing and administration. ¹

ELIDEL® Cream is contraindicated in individuals with known or suspected hypersensitivity to pimecrolimus or any component of the cream. ELIDEL® should not be applied to areas of active cutaneous viral infections, and clinical infections at treatment sites should be cleared before treatment. Patients should minimize or avoid exposure to natural or artificial sunlight while using ELIDEL®.¹

Vehicle-Controlled Studies in Pediatrics
Two identical 6-week, randomized, vehicle-controlled, multi-center, phase 3 trials were conducted to evaluate ELIDEL® Cream 1% for the treatment of mild to moderate eczema (atopic dermatitis). A total of 403 pediatric patients 2-18 years old were included in the studies. The male/female ratio was approximately 50% and 29% of the patients were African American. At study entry, 59% of patients had moderate disease and the mean body surface area (BSA) affected was 26%. About 75% of patients had atopic dermatitis affecting the face and/or neck region.¹ 

In these studies, patients applied either ELIDEL® Cream or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. At endpoint, based on the physician's global evaluation of clinical response, 35% of patients treated with ELIDEL® Cream were clear or almost clear of signs of atopic dermatitis compared to only 18% of vehicle treated patients. More ELIDEL® patients (57%) had mild or no pruritus at 6 weeks compared to vehicle patients (34%). The improvement in pruritus occurred in conjunction with the improvement of the patients' atopic dermatitis.¹

In these two 6-week studies of ELIDEL®, the combined efficacy results at endpoint are as follows:

In the two pediatric studies that independently support the use of ELIDEL® Cream in mild to moderate atopic dermatitis, a significant treatment effect was seen by Day 15. Of the key signs of atopic dermatitis, erythema, infiltration/papulation, lichenification, and excoriations, erythema and infiltration/papulation were reduced at day 8 when compared to vehicle.¹ 

Active-Comparative Controlled Study in Pediatrics
A 5-year, multi-center, open-label, parallel group, randomized study was conducted to demonstrate the safety of ELIDEL® cream (twice daily) compared with topical corticosteroids (TCS) in the treatment of infants 3 months to less than 12 months of age at enrollment with mild to moderate atopic dermatitis (AD):

• when used for 6 weeks during the acute state of the disease by assessing adverse events (AEs);
• when used for up to 5 years by assessing AEs and any potential effect on the developing immune system and growth velocity; and
• to document the long-term efficacy of ELIDEL® cream in the treatment of mild to moderate AD for up to 5 years (no statistical testing of efficacy was planned).

The facial Investigator's Global Assessment (IGA) rating was severe or very severe for 24 (1.0%) patients. The majority of patients (2415 patients, 99.9%) had an overall IGA rating of mild or moderate disease. Baseline disease characteristics of patients in the immunology/safety set and follow-up/safety set were similar to those for the safety set. ¹ 

Efficacy results: Overall, the efficacy parameters in the ELIDEL® treatment group in infants 3 to <12 months of age (at start of study) were similar to that observed in the topical corticosteroids (TCS) treatment group.¹

• At 3 weeks and 6 weeks of treatment (acute phase), overall IGA treatment success was achieved in more than 50% of patients in both treatment groups, and facial IGA treatment success was achieved in ≥ 61% of patients in both treatment groups. By the end of the fifth year of treatment, treatment success was still demonstrated among patients who remained in the trial.
• The total body surface area (TBSA) affected by AD decreased with both treatments in a similar manner throughout the study. The mean TBSA affected at baseline was approximately 21% in both treatment groups and decreased to less than 10% by week 6 (acute phase) and was sustained to the end of five years in patients who remained in the trial for both treatment groups.

Overall conclusions: ELIDEL® cream was efficacious and well tolerated in subjects with mild to moderate AD who were 3 to 12 months of age at the start of the study. No impairment of systemic immune assessments was seen, and subjects with AD who were treated with ELIDEL® cream or TCS displayed normal immune response maturation and developed effective immunization against vaccine antigens.¹

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, neuroscience, 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, chronic weight management, allergy, neuroscience and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Québec, 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. ELIDEL® Cream Product Monograph. January 16, 2020. Available at: https://pdf.hres.ca/dpd_pm/00054703.PDF
2. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338–351. doi:10.1016/j.jaad.2013.10.010.
3. Lynde C, Barber K, Claveau J, et al. Canadian Practical Guide for the Treatment and Management of Atopic Dermatitis. J Cutan Med Surg. 2005. doi:10.1007/s10227-005-8080-3. Available from: https://link.springer.com/article/10.1007/s10227-005-8080-3

SOURCE Bausch Health Companies Inc.