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TRULANCE® (plecanatide tablets) for Irritable Bowel Syndrome with Constipation in Adults Is now Available to Canadians

CDHF

Written by: CDHF

Updated: November 24th, 2022

TRULANCE® (plecanatide tablets) for Irritable Bowel Syndrome with Constipation in Adults Is now Available to Canadians to Help Meet Treatment Gap that leaves 70 Per cent of Patients Unsatisfied1

February 8, 2022

LAVAL, QC, February 8, 2022 – Bausch Health, Canada, part of Bausch Health Companies Inc. (NYSE/TSX: BHC), (“Bausch Health” or the “Company”) today announced the availability through pharmacies across Canada of its new prescription treatment TRULANCE™ (plecanatide).

TRULANCE® is approved by Health Canada for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults,2 and is the first treatment brought to market in Canada by the gastrointestinal division of the Company. Canadian treatment guidelines for IBS-C recommend a variety of non-pharmaceutical and pharmaceutical approaches to treatment,3 but 70 per cent of surveyed IBS-C patients report no treatment had thus far completely relieved their symptoms.4

“Bausch Health, Canada is proud to launch TRULANCE as the first therapy brought to the Canadian market in an area where there is a great unmet need for Canadian patients and for a condition for which the prevalence in Canada is one of the highest in the world,” said Ginette Gagné, interim president and general manager and vice president, Finance, Bausch Health, Canada. “We know doctors are seeking alternatives to improve care for those Canadians with the often-debilitating symptoms of IBS-C.”

TRULANCE® provides a solution to the treatment gap currently experienced by patients suffering from IBS-C.

In a recent survey of IBS-C patients across Canada, almost three out of four (72 per cent) said not all their symptoms are under control. Almost six out of 10 (57 per cent) said their symptoms prevent them from enjoying their daily activities and roughly the same number (56 per cent) feel their symptoms prevent them from reaching their full potential in life.5 The seriousness and impact of IBS symptoms is reflected in a 2018 survey in which Canadians with IBS reported they would give up 25 per cent of their remaining life (15 years) to live a symptom-free life.6

“Many people with IBS-C suffer in silence or with unsatisfactory treatments, because it is not a life-threatening acute disease, but it does have a big impact on their lives,” said Dr. Louis Liu, chief, Division of Gastroenterology and Hepatology, University Health Network, Toronto. “It often affects people in early-to-middle age during the very busy and productive part of their lives, so it is important that it gets treated to the best extent possible, which is why having a new treatment option is very useful.”

“We welcome a new treatment for IBS-C for Canadians, because we know current treatment options are not meeting the needs of every person with this condition,” said Gail Attara, chief executive officer of the Gastrointestinal Society. “Our own large survey of persons living with IBS showed that only one in five felt confident their symptoms were under control.7 This clearly demonstrates a dire need for new treatment options for those who are living with this invisible condition.”

With the prevalence of IBS being so high in Canada, we are thrilled to hear there is a new treatment option available to help Canadians manage the symptoms and severity of IBS-C,” said Kelsey Cheyne, executive director of the Canadian Digestive Health Foundation. “This works towards our vision to help empower all Canadians to manage their digestive health with confidence and optimism.”

About irritable bowel syndrome with constipation (IBS-C)

Irritable bowel syndrome (IBS) involves frequent and intense symptoms of abdominal cramping, bloating, constipation or diarrhea to the extent that they interfere with day-to-day living.8 IBS-C is one of four subtypes of IBS, which occurs when the digestive system contracts slowly, delaying transit time for products of digestion, resulting in hard, difficult to pass, infrequent stools (constipation). The other forms are IBS-D (diarrhea) and IBS-M (mixed, both constipation and diarrhea symptoms) and IBS-U (unclassified). Constipation-predominant IBS represents about 30% of IBS cases.9

IBS affects up to one in five Canadians at any given time10 and Canada has one of the highest prevalences of the condition in the world.11 The lifetime risk for a Canadian to develop IBS is 30%, with it affecting 20% of the population at any given time, and in Canada and most Western nations, IBS arises significantly more frequently in women than in men.12 Two-thirds (67%) of Canadians with IBS-C say their symptoms make them feel self-conscious, and 60% say it is difficult for them to plan things, because they never know when their symptoms will act up; half (51%) say their symptoms cause them to stay home often.13

About TRULANCE® (plecanatide tablets) in Canada

TRULANCE® is a guanylate cyclase-C agonist, which mimics the effect of natural hormones in the body, giving it a unique method of action which allows it to act in the small intestine in a pH-sensitive manner to facilitate fluid secretion, increase intestinal transit, and decrease the activity of pain-sensitive nerves in the intestines.14 In clinical studies, TRULANCE® provided a statistically significant patient self-evaluated reduction in IBS disease severity and a statistically significant reduction in IBS symptoms versus placebo.15 In the two clinical trials on which the approval of TRULANCE® was based, 30.2 per cent and 21.5 per cent respectively of TRULANCE® patients were considered overall responders, meaning they experienced both a significant decrease in abdominal pain and a significant increase in complete spontaneous bowel movements compared to those on placebo.16 In clinical trials, the incidence of serious adverse events in patients using TRULANCE® was low (0.8 per cent) and similar to that recorded in the placebo arm of the studies.17 TRULANCE® has not been studied in or approved for patients under the age of 18.18

About the IBS-C patient survey19

Statistics about the current attitudes and experiences of Canadians with IBS-C come from a comprehensive survey commissioned by Bausch Health, Canada in September and October 2021 and conducted by the research firm Callosum. The survey received data from 784 Canadians aged 18 and older who have been diagnosed with IBS-C specifically or have diagnosed with IBS generally but have symptoms of constipation. The average age of respondents was 47 years; 72% were females and 28% were males, reflecting the greater incidence of IBS-C among females. Respondents came from all regions of Canada in very close proportion to each region’s respective share of the Canadian population.

About Bausch Health Companies Inc.

Bausch Health logo

REFERENCES

1. Bausch Health, Canada, Understanding Patients’ Perceptions and Treatment Habits of IBS-C, research report by Callosum, October 2021, p. 15.

2. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Indications, p. 4.

3. Moayyedi P et al, Canadian Association of Gastroenterology Clinical Practice Guideline for the Management of Irritable Bowel Syndrome (IBS), Journal of the Canadian Association of Gastroenterology, 2019, 2(1), 6–29.

4. Bausch Health, Canada, Understanding Patients’ Perceptions and Treatment Habits of IBS-C, research report by Callosum, October 2021, p. 15.

5. Bausch Health, Canada, Understanding Patients’ Perceptions and Treatment Habits of IBS-C, research report by Callosum, October 2021, p. 14.

6. Canadian Digestive Health Foundation, Irritable Bowel Syndrome Statistics, https://cdhf.ca/digestive-disorders/irritable-bowel-syndrome-ibs/statistics/.

7. Gastrointestinal Society. 2016 Survey Results Irritable Bowel Syndrome (IBS). https://badgut.org/ibs-survey-results/.

8. Gastrointestinal Society, Irritable Bowel Syndrome (IBS), https://badgut.org/information-centre/a-z-digestive-topics/ibs/.

9. Ibid.

10. Ibid.

11. Canadian Digestive Health Foundation, Irritable Bowel Syndrome Statistics, https://cdhf.ca/digestive-disorders/irritable-bowel-syndrome-ibs/statistics/.

12. Gastrointestinal Society, Irritable Bowel Syndrome (IBS), https://badgut.org/information-centre/a-z-digestive-topics/ibs/.

13. Bausch Health, Canada, Understanding Patients’ Perceptions and Treatment Habits of IBS-C, research report by Callosum, October 2021, p. 14.

14. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Mechanism of Action, p. 11-12.

15. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Clinical Trials, Patient Global Rating (PGR) Assessments, p. 19

16. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Study Results, p. 16.

17. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Adverse Reactions Overview, p. 9

18. Bausch Health, Canada, TRULANCE Product Monograph dated March 17, 2021, Pediatrics, p. 4.

19. Bausch Health, Canada, Understanding Patients’ Perceptions and Treatment Habits of IBS-C, research report by Callosum, October 2021.

________________________

For further information:

Bausch Health Investor Contact: Arthur Shannon, Bausch Health, Arthur.Shannon@BauschHealth.com, (514) 856-3855, (877) 281-6642 (toll free)

Media Contact: Julia Park, Agnostic/Capital-Image (519) 535-7940 / jpark@thinkagnostic.com

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