Now Available in Canada - Bausch Health, Canada Launches First of its Kind, Topical Antipsoriatic Agent in Almost Twenty Years

Formulated with PRISMATREX™, a proprietary technology, DUOBRII™ lotion improves the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.

LAVAL, QC, Sept. 2, 2020 /CNW Telbec/ - Bausch Health, Canada, part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") today announced that its novel topical prescription drug for improving the signs and symptoms of plaque psoriasis in adult patients is now available in Canada. DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) is indicated for adults with moderate to severe plaque psoriasis.ⁱ The product is manufactured for distribution throughout Canada and the United States at the Company's Quebec manufacturing facility in Laval.

"Achieving clear skin is the primary goal of patients, and this is equally so for the physicians who treat them," says Richard Lajoie, President and General Manager, Bausch Health, Canada. "As a company fully committed to the Canadian psoriasis community, we are sensitive to the challenges faced in improving the quality of life of patients with psoriasis. DUOBRII works in a unique way by combining halobetasol propionate, which reduces inflammation; and tazarotene that contributes to the normalization of skin cell growth. We are excited to bring this novel product to Canadians and very proud that it is being manufactured at our own facility here in Canada."

Dr. Neil H. Shear, MD, FRCPC, Professor and Head of Dermatology, Sunnybrook Health Sciences Centre has spent decades treating psoriasis patients. "Offering my patients a new option with promising, long-term results will help deliver what every psoriasis patient hopes for: achieving clear skin. Psoriasis is a chronic condition, which means that patients need continuous solutions to manage their symptoms. With DUOBRII, we are seeing positive results in as little as two weeks, which is highly encouraging. The fact that it is the only Health Canada-approved drug for psoriasis to provide extended clearance post-treatment is an important benefit."

Psoriasis is a common, chronic, and life-altering skin condition that affects approximately one million Canadians, with 90% of those affected suffering from plaque psoriasis.ⁱⁱ

The disease is characterized by red elevated patches and flaking silvery scales, and symptoms can range from mild to severe. While the psoriatic lesions can appear anywhere on the body, the most common places include the elbows, knees, scalp, chest and lower back. Because the disease typically affects visible parts of the body, the impact on patients extends well beyond the physical symptoms. Psoriasis often impacts nearly every aspect of an individual's life including their ability to work and maintain social and intimate relationships. In addition to the tremendous medical burden experienced while trying to find a medication that controls the disease, the psychological impact is high. Many individuals suffer from low self-confidence, anxiety, depression and sleep deprivation.ⁱⁱⁱ

"We know how difficult psoriasis is to treat and it is even harder to live with for patients and their families," said Rachael Manion, Executive Director of the Canadian Association of Psoriasis Patients (CAPP). "Patients deserve the most advanced and effective treatment options available, and we are encouraged that Bausch Health, Canada has brought DUOBRII to market as a new topical treatment option for patients with moderate to severe psoriasis."

DUOBRII lotion provides the combined action of two unrelated compounds, halobetasol propionate, a corticosteroid, and tazarotene, a retinoid prodrug. These well-known ingredients have long-established efficacy profiles. When halobetasol propionate and tazarotene are administered together in DUOBRII, they provide complementary effects due to their individual modes of action targeting different receptors and pathways to achieve anti-inflammatory control and epidermal morphologic restoration. The improvement that is seen in psoriatic patients appears to occur in association with the restoration of normal cutaneous morphology and the reduction of the inflammatory markers ICAM-1 and HLA-DR.^iv

DUOBRII is also distinct based on its Prismatrex™ technology, a polymeric emulsification system which provides a stable condition where emulsion droplets retained their distribution across time and temperature.^v

The clinical efficacy and safety of once daily use of DUOBRII were assessed in two prospective, multi-centre, randomized, double-blind Phase III clinical trials in subjects 18 years and older with moderate to severe plaque psoriasis. In the Phase III pivotal studies, analysis of the primary efficacy endpoint demonstrated that Duobrii was statistically significantly more effective than Vehicle Lotion in achieving treatment success in the Investigator's Global Assessment (IGA) at Week 8, defined as at least a 2-grade improvement from Baseline and a score of Clear or Almost Clear in both studies.^vi 

In the first study 35.76% of subjects in the DUOBRII group had treatment success at Week 8 compared with 6.98% in the Vehicle group. In the second study, 45.33% of the subjects in the Duobrii group had treatment success at Week 8 compared with 12.51% in the Vehicle group.^vi In the clinical studies, the individual signs of psoriasis (erythema, plaque elevation, and scaling) showed sustained efficacy improvement up to 4 weeks after treatment.^vii

While the exact cause of psoriasis has not yet been determined, researchers believe it involves a combination of genetic, environmental, and immune factors. Psoriasis develops when there is a malfunctioning of the immune system which causes inflammation. White blood cells (T cells) in the immune system are triggered and this causes inflammation to occur, which then causes skin cells to rise to the surface and shed at 10 times the normal rate.

About Bausch Health Companies Inc.
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology, and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.

In Canada, the Company's prescription product portfolio is focused on eye health, dermatology, and cardio-metabolic conditions. More information can be found on the Company's website at bauschhealth.ca.

SOURCE Bausch Health