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Bausch Health, Canada Inc. Announces Additional Public Drug Plan Listings for PrUCERIS(R) (Budesonide) Aerosol Foam To Treat Mild to Moderate Distal Ulcerative Colitis in Adults

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Bausch Health, Canada announced additional public drug plan listings for PrUCERIS (budesonide) aerosol foam, expanding access for adults with mild to moderate distal ulcerative colitis. New listings include Alberta, Prince Edward Island, Newfoundland and Labrador, and federal plans for Indigenous people and Veterans. Previously, UCERIS was available in Ontario, Quebec, Saskatchewan, New Brunswick, and Nova Scotia. UCERIS, approved in Canada since September 2023, offers a unique glucocorticosteroid rectal foam for remission induction. Clinical trials showed superior efficacy over placebo in remission and rectal bleeding control at Week 6.

Positive
  • Expanded access to PrUCERIS in Alberta, Prince Edward Island, Newfoundland and Labrador, and federal plans for Indigenous and Veterans.
  • Previously listed in Ontario, Quebec, Saskatchewan, New Brunswick, and Nova Scotia.
  • UCERIS offers a unique glucocorticosteroid rectal foam formulation.
  • Clinical trials demonstrated significant efficacy over placebo in remission and rectal bleeding control at Week 6.
  • 84% of patients preferred UCERIS foam over enema due to better tolerability and easier application.
Negative
  • No direct financial figures or projected revenue impact mentioned.
  • Potential market competition from other treatments for distal ulcerative colitis.
  • Late entry into the market as UCERIS was approved only in September 2023.

Insights

The expansion of public drug plan listings for UCERIS aerosol foam brings immediate and widespread access to a significant patient demographic across several provinces. This is particularly relevant in the treatment of ulcerative colitis, a chronic and often debilitating condition. The increased access is likely to enhance patient compliance and treatment outcomes due to the better tolerability and easier application of the foam formulation compared to traditional enema treatments.

Clinical data showed that UCERIS demonstrated significantly higher remission rates and reductions in rectal bleeding compared to placebo. These results indicate robust efficacy, which can bolster physician confidence in prescribing this treatment. Furthermore, its unique position as the only approved glucocorticosteroid rectal foam in Canada may offer a competitive advantage, which could drive market share growth in the gastrointestinal therapeutic segment.

A potential long-term benefit is the reduction in healthcare costs associated with managing poorly controlled ulcerative colitis, as effective treatments reduce the need for emergency care and hospitalizations. However, it is important to consider that accessibility does not guarantee immediate uptake and patient education efforts will be important to maximize benefits.

From a market perspective, the expansion of UCERIS listings under public drug plans across multiple provinces enhances Bausch Health's market reach within the Canadian healthcare system. Public drug coverage often translates to higher adoption rates, especially in regions with significant portions of the population reliant on such plans.

The inclusion across diverse plans, including those for Indigenous populations and veterans, broadens the demographic footprint and underscores the drug's perceived value across different population groups. This strategic move can help Bausch Health strengthen its position in the gastrointestinal therapeutic market and possibly lead to increased revenue streams.

However, market penetration will depend on competitive dynamics and how effectively Bausch Health can differentiate UCERIS from other treatments. Ongoing physician engagement and demonstrating superior clinical outcomes will be important for sustaining market momentum.

LAVAL, QC / ACCESSWIRE / May 23, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced additional Canadian public drug plan listings for Pr UCERIS ® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults. 1

UCERIS has most recently become available for patients through the public drug plans of Alberta, Prince Edward Island and Newfoundland and Labrador, as well as to beneficiaries of the federal drug plans for Indigenous people through the Non-Insured Health Benefit (NIHB) and Veterans Affairs Canada.

Earlier this year, UCERIS was made available for patients through the public drug plans of Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia.

"We are very pleased that these further public drug plan listings for UCERIS mean more Canadians with distal ulcerative colitis now have access to this new therapy," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "It is encouraging that these public drug plans have moved quickly to finalize their listings after our agreement in principle following negotiations with the pan-Canadian Pharmaceutical Alliance."

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

Investor Contact:

Media Contact:
Garen SarafianKevin Wiggins

ir@bauschhealth.com

corporate.communications@bauschhealth.com

(877) 281-6642 (toll free)

(908) 541-3785




SOURCE: Bausch Health Companies Inc.



View the original press release on accesswire.com

FAQ

What is PrUCERIS (budesonide) aerosol foam used for?

PrUCERIS is used to treat mild to moderate distal ulcerative colitis in adults.

When was PrUCERIS approved in Canada?

PrUCERIS was approved in Canada in September 2023.

What are the new public drug plan listings for PrUCERIS?

New listings include Alberta, Prince Edward Island, Newfoundland and Labrador, and federal plans for Indigenous and Veterans.

How effective is PrUCERIS compared to placebo?

Clinical trials showed significantly higher remission rates and rectal bleeding control at Week 6 compared to placebo.

What percentage of patients preferred PrUCERIS foam over enema?

84% of patients preferred PrUCERIS foam due to better tolerability and easier application.

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