Bausch Health, Canada Inc. Announces First Public Drug Plan Listings for (Pr)UCERIS(R) (budesonide) Aerosol Foam to Help Address the Unmet Need for the Treatment of Mild to Moderate Distal Ulcerative Colitis in Adults

LAVAL, QC / ACCESSWIRE / April 3, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced the first public drug plan listings for ^PrUCERIS^® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.¹

UCERIS is now available for patients through the public drug plans of five Canadian provinces: Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia.

These first public drug plan listings for UCERIS come following the signing of a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) early this year, setting out the parameters for listing of the treatment by the public drug plans of the provinces, territories and federal government.

"Bausch Health is very pleased that patients with distal ulcerative colitis in five provinces, including the two largest, will now have access to UCERIS and we look forward to the rapid completion of listing agreements with other public drug plans so more Canadians will have insured access to this new therapy," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "We want to provide additional effective treatment options to Canadians."

UCERIS, part of the Company's growing gastrointestinal franchise, has been available in Canada by prescription since September 2023 and is covered by the majority of private insurance drug plans in Canada.

"Living with ulcerative colitis means experiencing painful, frequent bowel movements, which can also be bloody. Effective treatments for this chronic inflammatory bowel disease are vital to have any quality of life," said Gail Attara, President and Chief Executive Officer of the Gastrointestinal Society, a patient group known by its badgut.org website. "We are pleased that public drug plans in Canada are starting to make the new ulcerative colitis treatment UCERIS available as a covered benefit and look forward to their example being followed by all drug insurance plans across Canada."

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

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

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.¹

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, healthcare professionals, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

The Bausch Health Canadian 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.

REFERENCES

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, Aliment Pharmacol Ther. 2006;23(2):303-312.
³ IBD Clinic, University of Alberta: http://www.ibdclinic.ca/what-is-ibd/ulcerative-colitis/.

SOURCE: Bausch Health Companies Inc.