Bausch Health Announces Updated Health Canada Safety Information for ELIDEL®

TOPICAL ATOPIC DERMATITIS TREATMENT, ELIDEL^® NOW AVAILABLE
FOR CHILDREN THREE MONTHS AND OVER

LAVAL, QC, Oct. 17, 2019 /CNW/ - Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced that Health Canada has approved the extension of the indication of ELIDEL® (pimecrolimus cream1%), its prescription treatment for mild to moderate atopic dermatitis, commonly known as eczema, to include patients three months of age and older instead of two years as was previously indicated. Additionally, under the Warnings and Precautions section, the long-term use and safety limitations of ELIDEL^® have been removed.ⁱ The changes are based on Health Canada's review of data.

Part of a class of drugs called topical calcineurin inhibitors, ELIDEL^® cream is a steroid-free topical medicine that treats inflammation of the skin. It works on specific cells in the skin that cause inflammation and lead to the characteristic redness, scaling and itching of eczema. ELIDEL^® non-steroid cream can be applied to all areas of the skin that have been diagnosed by a physician as having atopic dermatitis, including sensitive parts like the face and eyelids.

"Bausch Health, Canada is committed to supporting patients, families and healthcare professionals with products that improve people's lives. The major changes to the safety information that Health Canada has authorized for ELIDEL® are welcome news for the Canadian eczema community," said Richard Lajoie, President and General Manager, Bausch Health Canada. "Not only will physicians be able to include ELIDEL^® as a treatment option for their younger pediatric patients, they will be able to prescribe it with even more confidence for all users."

"Topical calcineurin inhibitors are an important therapeutic class for the treatment of atopic dermatitis in both children and adults. They provide physicians with an effective option in reducing the inflammation and managing the rash-itch cycle that makes living with eczema so difficult for sufferers and their care providers." said Dr. Simone Fahim, MD FRCPC, Assistant Professor in the Department of Medicine, Division of Dermatology, University of Ottawa. "With the updated safety information for ELIDEL®, physicians, pharmacists, patients and their families have an additional treatment option available to them. This update and reassurance regarding the safety of the treatment is terribly important when it comes to counselling our patients on how to manage this condition."

"Managing a child with eczema can be overwhelming, worrisome, and frustrating," said Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. "Parents often struggle to cope with their child's condition, and we are always looking for ways to help simplify treatment regimens. Health Canada's approval of ELIDEL® for younger children and updated safety information will help to provide more choice for families when treating this challenging disease."

ELIDEL^® Side Effects
The most common side effects of ELIDEL^® are a burning feeling or a sensation of warmth at the site of application. These side effects are usually mild to moderate and usually clear up in the first few days of using ELIDEL^®. Other common side effects include headache, and with long term intermittent use, nose and throat infection and flu like symptoms such as fever, viral infection, and cough. For complete information on ELIDEL^®, including safety data and patient information, please refer to the updated product monograph at https://pdf.hres.ca/dpd_pm/00053301.PDF.

About Eczema
It is estimated that up to 17% of Canadians suffer from atopic dermatitis (AD) or eczema at some point in their lives.ⁱⁱ AD usually starts in infants and young children and is characterized by itchy, inflamed skin, usually behind the knees, the inside of the elbows, and on the face, neck and hands. The condition affects both children and adults and quite often members of the same family. One of the most common symptoms is itching which can be almost unbearable. Other symptoms include dryness of the skin, redness and inflammation. AD patients can have periods of remission; however, some patients never experience complete remission from these life altering symptoms and all forms of the disease can have significant quality of life impact on patients, caregivers, and their loved ones.

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 at the Company's website at https://www.bauschhealth.ca.

SOURCE Bausch Health

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