Bausch Health Announces Availability of SILIQ™ (Brodalumab) For the Treatment of Moderate-To-Severe Plaque Psoriasis in Canada

LAVAL, QC, Sept. 24, 2018 /CNW/ - Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or "the Company") announced that SILIQ^TM (brodalumab) is now available in Canada and is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. SILIQ^TM, for subcutaneous injection, is the first and only human monoclonal antibody that selectively targets the IL-17 receptor subunit A.

"We are proud to offer Canadians a new option to treat moderate-to-severe plaque psoriasis with a comprehensive Patient Support Program, fulfilling a significant unmet medical need and improving patients' lives," said Richard Lajoie, President, Canada, Bausch Health. "SILIQ™ is an innovative, effective and cost-effective treatment that can provide savings to private insurance and government health plans. The pricing of SILIQ™ demonstrates our commitment to making our medicines affordable for the patients who need them, and we will work closely with private and public payers to list SILIQ™ in their health care plans as soon as possible to ensure patients have access to this important new treatment."

Plaque psoriasis is the most common type of psoriasis, a chronic, non-communicable, skin disease.¹ The disease alters the life cycle of skin cells, causing them to build up rapidly on the surface of the skin. SILIQ™ works by binding to IL-17 Receptor A with high affinity, thereby blocking the inflammatory downstream activity of IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C, and IL-17E. By targeting the IL-17 receptor, SILIQ™ works to prevents the accumulation of excess skin cells in psoriatic plaques and improves the signs and symptoms of psoriasis. In three phase 3 clinical studies that have been completed, between 51 and 67.5% of patients who used SILIQ™ achieved total skin clearance within a year^2,3. Psoriasis Area Severity Index (PASI) 100, or "[c]omplete skin clearance represents a clinically meaningful end point and outcome for patients, reflected in experiences of no psoriasis symptoms and no impairment on health-related quality of life."²

"The availability of SILIQ™ gives doctors and patients an effective new option to treat plaque psoriasis," said Dr. Kim Papp, MD, PhD, FRCPC. "SILIQ™ is the only biologic that has demonstrated a Psoriasis Area Severity Index (PASI) 100 for complete skin clearance as a primary endpoint. As the first IL-17 receptor A blocker, SILIQ™ blocks the activity of the pro-inflammatory IL-17 cytokine family. This blockade results in thorough and rapid normalization of the psoriatic skin inflammation."

"Patients are looking for new treatments that can empower them to live full lives while they manage their chronic moderate-to-severe plaque psoriasis," said Canadian Association of Psoriasis Patients President, Kathryn Clay. "Having effective treatment options is imperative for patients suffering from moderate to severe plaque psoriasis and we are pleased that SILIQ™ is now available in Canada."

SILIQ™ received its Notice of Compliance (NOC) from Health Canada on March 6, 2018.

WARNING: SUICIDAL IDEATION AND BEHAVIOUR
SILIQ™ has a warning/precaution for the risk in patients with a history of suicidal thoughts or behaviours. SILIQ™ was approved with a comprehensive Patient Support Program that supports patients and healthcare professionals with the prescribing, administration, delivering and monitoring of patients who receive SILIQ™ treatment. The most common adverse reactions were headache, arthralgia, fatigue, oropharyngeal pain, and diarrhea. SILIQ™ is contraindicated in patients with Crohn's disease. Suicidal ideation and behaviour have been reported. Serious infections have occurred; therefore, caution should be exercised when considering the use of SILIQ™ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment.

Knowing that psoriasis is associated with higher rates of depression, anxiety and Suicidal Ideation & Behaviours (SIBs), Bausch Health will ensure that health care professionals and their patients are informed and educated about SIBs before initiating, and during, treatment with SILIQ™. SIBs have occurred in patients treated with SILIQ™. A causal association between treatment with SILIQ™ and increased risk of SIBs has not been established.

Bausch Health has exclusively licensed the rights to SILIQ™ in Canada from AstraZeneca.

About SILIQ™
SILIQ™ is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by preventing the binding of several types of IL-17 to the receptor. By blocking IL-17 from activating the receptor, SILIQ™ prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

About Bausch Health
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.

In Canada, our areas of focus include eye health, dermatology and cardio-metabolic. We are delivering on our commitments as we build an innovative company dedicated to advancing the health of Canadians. More information can be found at the Company's website.

References:

1. Global Report on Psoriasis, World Health Organization.
2. SILIQ Product Monograph, Valeant Canada LP, 2018.
3. Papp KA, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. N Eng J Med 2016;175(2):273-286.
4. Strober B, et al. Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol 2016 Jul;75(1):77-82.
5. Kurd SK, et al. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol 2010;146(8):891-895.

SOURCE Bausch Health

For further information: Media: Boyd Erman, Longview Communications, Email: [email protected], 416-649-8007; Lainie Keller, Vice President, Corporate Communications, Email: [email protected], 908-927-0617; Investor Contact: Arthur Shannon, Email: [email protected], [phone], [phone] (toll free)

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