BAUSCH HEALTH COMPANIES INC. (NYSE:BHC) New Bausch Health Treatment PrUCERIS(R) (budesonide) Aerosol Foam Now Available Across Canada to Treat Mild to Moderate Distal Ulcerative Colitis in Adults

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12/09/2023 14:00

LAVAL, QE / ACCESSWIRE / September 12, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is pleased to announce that following its approval by Health Canada the new treatment PrUCERIS® (budesonide) aerosol foam is now available across Canada to treat mild to moderate distal ulcerative colitis in adults.

UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.[1] In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.[2]

"Bausch Health is pleased to make this new treatment for ulcerative colitis available to Canadians, providing an innovative therapy option using a convenient aerosol foam," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "This is part of our commitment to being a trusted partner in the healthcare of Canadians."

Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.3 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).[3]

"Distal ulcerative colitis can be challenging for patients to live with and gastroenterologists to treat. Our goal is to put the disease into remission so that patients can improve their quality of life," said Dr. Brian Bressler, Founder of The IBD Centre of BC in Vancouver and Clinical Associate Professor of Medicine in the Division of Gastroenterology at the University of British Columbia. "UCERIS can help overcome current treatment limitations by reaching the affected area of the distal colon and keeping the medication there long enough to be effective. People suffering from distal ulcerative colitis will have another option to consider when facing this disease."

"Living with ulcerative colitis can mean painful, frequent and, at times, bloody stools." said Gail Attara, president and chief executive officer of the Gastrointestinal Society, a patient group known by its badgut.org website. "We look forward to this product being widely available for individuals living with ulcerative colitis who need a good treatment option that is easy to use, which targets the disease directly. UCERIS is an effective solution, meeting the disease right where it happens."

UCERIS is available in one strength: 2 mg budesonide per metered dose and is applied starting twice a day for two weeks followed by once a day for the next four weeks.[4]

In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.[5]

About Bausch Health

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.

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[1] Bausch Health, Canada Inc., UCERIS rectal foam Product Monograph, https://bauschhealth.ca/wp-content/uploads/2022/06/Uceris-PM-E-2020-04-15.pdf

[2] Gross V, et al, Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis, Ailment Pharmacol Ther. 2006;23(2):303-312

[3] IBD Clinic, University of Alberta: http://www.ibdclinic.ca/what-is-ibd/ulcerative-colitis/

[4] Bausch Health, Canada Inc., UCERIS rectal foam Product Monograph, p. 4 and 16, https://bauschhealth.ca/wp-content/uploads/2022/06/Uceris-PM-E-2020-04-15.pdf

[5] Bausch Health, Canada Inc., UCERIS rectal foam Product Monograph, p. 19, https://bauschhealth.ca/wp-content/uploads/2022/06/Uceris-PM-E-2020-04-15.pdf

SOURCE: Bausch Health Companies Inc.

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