Valeant Receives Health Canada Approval of SILIQ™ (Brodalumab) For Moderate-To-Severe Plaque Psoriasis

LAVAL, QC, March 14, 2018 /CNW/ - Valeant Canada ("Valeant" or the "Company") announced that Health Canada granted on March 6 the Notice of Compliance (NOC) for SILIQ™ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis. SILIQ™ is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Valeant expects to commence sales and marketing of SILIQ™ in the Canada in the second half of 2018.

"We believe SILIQ™ fulfills a significant unmet medical need with its potential to improve the quality of life for many patients across Canada who suffer from moderate-to-severe plaque psoriasis," said Richard Lajoie, president of Valeant Canada. "Our team's success in bringing to market this important treatment for people who live with this debilitating, incurable condition demonstrates our commitment to Valeant's mission of improving people's lives with our healthcare products."

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-17Receptor A with high affinity, thereby blocking the inflammatory downstream activity of IL-17A, IL-17F, IL-17A/F heterodimer and IL-17E. By targeting the IL-17 receptor, SILIQ™ prevents skin cells from accumulating. 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. 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

"An additional biologic has just received its approval: SILIQ™ is the only biologic in the treatment of plaque psoriasis that has demonstrated a Psoriasis Area Severity Index (PASI) 100 as a primary endpoint," said Dr. Charles W. Lynde, MD, FRCPC, Diplomate American Boards, Dermatology, Associate Professor in the Department of Medicine at University of Toronto. "This IL-17A receptor antagonist decreases the pro-inflammatory cytokines IL-17resulting in rapid normalization of the psoriatic skin inflammation. Our moderate-to-severe plaque type psoriasis patients will benefit from this new drug being now on the market."

"We are happy to hear that SILIQ™ is now available in Canada," said Kathryn Andrews-Clay, Executive Director, Canadian Association of Psoriasis Patients and the Canadian Skin Patient Alliance. "We believe that every patient should have access to effective treatment options, so we are very pleased that SILIQ™ is a new option available to Canadians living with moderate to severe psoriasis. Having effective treatment is so important for these patients who live with the pain and stigma of this chronic disease. Finding an effective treatment for them translates into an increased quality of life and an ability to participate fully in their day-to-day activities." 

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.

WARNING: SUICIDAL IDEATION AND BEHAVIOUR
Knowing that psoriasis is associated with higher rates of depression, anxiety and Suicidal Ideation & Behaviours (SIBs), Valeant Canada 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.

In August 2015, Valeant Pharmaceuticals International Inc. entered into a collaboration agreement with AstraZeneca granting Valeant Pharmaceuticals International an exclusive license to develop and commercialize SILIQ™ globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd. In July 2016, AstraZeneca and Valeant amended Valeant Pharmaceuticals International's license for brodalumab to terminate Valeant Pharmaceutical International's right to develop and commercialize brodalumab in Europe. LEO Pharma currently holds exclusive rights to develop and commercialize brodalumab in Europe, and Valeant Pharmaceutical International holds the license to develop and commercialize SILIQ™ in the U.S and other territories, other than Japan and certain other Asian countries. The Marketing Authorisation Application (MAA) for Brodalumab (marketed as Kyntheum) in moderate-to-severe psoriasis was accepted by the European Medicines Agency (EMA) in the fourth quarter of 2015.  In July 2016, brodalumab (marketed as LUMICEF) was granted approval from the Ministry of Health, Labour and Welfare Japan.

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 Valeant Canada

Valeant Canada is a subsidiary of Valeant Pharmaceuticals International Inc., a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant Canada can be found at www.valeantcanada.com.

Forward-looking Statements

This press release may contain forward-looking statements which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements 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. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the 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. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.

^1	Source: Global Report on Psoriasis, World Health Organization.
^2	"Clinical meaningfulness of complete skin clearance in psoriasis," Strober B^1, Papp KA^2, Lebwohl M^3, Reich K^4, Paul C^5, Blauvelt A^6, Gordon KB^7, Milmont CE^8, Viswanathan HN^8, Li J^8, Pinto L^8, Harrison DJ^8, Kricorian G^8, Nirula A^8, Klekotka P^8. J Am Acad Dermatol. 2016 Jul;75(1):77-82.e7. doi: 10.1016/j.jaad.2016.03.026. Epub 2016 May 17, Abstract conclusions.

SOURCE Valeant Canada

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