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Bausch Health Announces Favorable Topline Results From Study Evaluating Investigative Formulation of Rifaximin SSD IR to Treat Overt Hepatic Encephalopathy

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Study Arm Evaluating 40 MG BID of Rifaximin SSD IR In Combination with Standard of Care Therapy Met Primary Endpoint

LAVAL, Quebec, March 31, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health" or the "Company") today announced topline results from a Phase 2 study evaluating an investigative soluble solid dispersion (SSD) formulation of immediate release (IR) rifaximin in combination therapy with the current standard of care therapy, lactulose, for the treatment of Overt Hepatic Encephalopathy (OHE).

In the double-blinded, placebo-controlled multi-arm, dose-ranging study, the treatment arm evaluating 40 mg BID of rifaximin SSD IR plus standard of care therapy met its primary endpoint of time to resolution of OHE using the Hepatic Encephalopathy Grading Instrument (HEGI) scale. The 40 mg BID rifaximin SSD IR in combination with standard of care therapy treatment arm was statistically significantly superior to the placebo plus standard of care therapy treatment arm with median time to resolution being 21.1 hours versus 62.7 hours, respectively. The rates of adverse events were comparable across all treatment arms of the study.

"The topline results of this study will help inform further research on potential new indications for rifaximin using this formulation," said Joseph C. Papa, chairman and CEO, Bausch Health. "Our R&D team will continue to analyze the full results of this dose-ranging study for further insights and present them in an upcoming scientific forum."

About Bausch Health
Bausch Health Companies Inc. (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. More information can be found at www.bauschhealth.com.

Forward-looking Statements
This news release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on the Company, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

Investor Contact:

Media Contact:

Arthur Shannon

Lainie Keller

arthur.shannon@bauschhealth.com 

lainie.keller@bauschhealth.com

(514) 856-3855

(908) 927-1198

(877) 281-6642 (toll free)


 

Bausch Health logo (PRNewsfoto/Bausch Health Companies Inc.)

 

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SOURCE Bausch Health Companies Inc.

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