Bausch Health’s Ortho Dermatologics Business To Present Data At The Fall Clinical Dermatology Conference

18 Poster Presentations on Investigational and Existing Products

LAVAL, Quebec, Oct. 15, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of 18 posters during the Fall Clinical Dermatology Conference in Las Vegas (Oct. 17-20, 2019). The presentations will feature analyses on ALTRENO® (tretinoin 0.05%) Lotion, BRYHALI® (halobetasol propionate 0.01%) Lotion, DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion and SILIQ® (brodalumab) injection, as well as a new data on the investigational drug IDP-123 (tazarotene 0.045%) Lotion. Please see below for warning about suicidal ideation and behavior with SILIQ.

“At this year’s Fall Clinical, new data will be presented across our psoriasis and acne portfolios, which have expanded significantly over the last year with the FDA approvals of DUOBRII, BRYHALI and ALTRENO,” said Bill Humphries, president, Ortho Dermatologics. “A total of 18 posters will be presented during the meeting. This includes data on our investigational acne treatment IDP-123, which is currently under review by the FDA with a PDUFA date of Dec. 22, 2019, as well as analyses that further demonstrate the clinical benefits of our current portfolio. Doing so allows us to help address the unmet needs of patients and educate physicians with new information that can help inform their treatment decisions.”

The complete list of all poster presentations that will include Ortho Dermatologics products and pipeline programs during the meeting is as follows.

ALTRENO® (tretinoin) Lotion, 0.05%

• Bhatia et al. “A Randomized, Observer-blind, Split-face Study to Assess Compatibility of Facial Foundation Makeup with Tretinoin 0.05% Lotion and Skin Texture After Application”
• Han et al. “Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in an Asian Population”
• St. Surin-Lord et al. “Acne-Related Quality of Life: Efficacy of a Novel Tretinoin 0.05% Lotion in Male and Female Patients with Moderate-to-Severe Disease”
• Woolery-Lloyd et al. “Acne-Related Quality of Life: Correlation Between Acne Symptom Scores and Other Domains Following Treatment with Tretinoin 0.05% Lotion”

BRYHALI® (halobetasol propionate) Lotion, 0.01%

• Bhatia et al. “Halobetasol 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis of the Lower Extremities”

DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion

• Alexis et al. “Efficacy, Safety, and Tolerability of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in the Treatment of Moderate-to-Severe Plaque Psoriasis in a Hispanic Population: Post Hoc Analysis of Two Phase 3 Randomized Controlled Trials”
• Glick et al. “Efficacy of Halobetasol 0.01%/Tazarotene 0.045% (HP/TAZ) Fixed Combination in the Treatment of Moderate Plaque Psoriasis: Indirect Comparison Between Pooled Phase 3 Trials of HP/TAZ and Oral Treatment (Apremilast)”
• Gold et al. “Long-Term Management of Moderate-to-Severe Plaque Psoriasis: Maintenance of Treatment Success Following Cessation of Fixed Combination Halobetasol Propionate 0.01% And Tazarotene 0.045% (HP/TAZ) Lotion”
• Lebwohl et al. “Efficacy, Safety, and Tolerabilty of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in the Treatment of Severe Plaque Psoriasis: Post Hoc Analysis of Two Phase 3 Randomized Controlled Trials”
• Tanghetti et al. “Optimized Formulation for Topical Application of a Fixed Combination Halobetasol/Tazarotene Lotion Using Polymeric Emulsion Technology.”

SILIQ® (brodalumab) Injection

• Armstrong et al. “Importance of Complete Skin Clearance on Quality of Life: Analysis of Three Phase 3 Studies”
• Bhatia et al. “Maintenance and Improvement of Skin Clearance Response With Brodalumab Among Patients With Moderate-to-Severe Psoriasis”
• Gottlieb et al. “Long-term Efficacy and Safety of Brodalumab in Patients With or Without History of Psoriatic Arthritis: Analysis of Two Phase 3 Psoriasis Studies”
• Lebwohl et al. “Long-term Efficacy and Safety of Brodalumab in Patients With Psoriasis Who Did Not Respond to Prior Biologics”
• Leonardi et al. “Long-term Efficacy and Safety of Brodalumab Through 120 Weeks and After Withdrawal and Retreatment”
• Ehst et al. “Long-term Efficacy and Safety of Brodalumab in Patients With Psoriasis Disease Duration ≥10 Years: Analysis of Two Phase 3 Studies”
• Prussick et al. “Patients With Psoriasis Treated With Brodalumab: A Pooled Post Hoc Analysis of a Marker of Liver Inflammation in Individuals With Potential Indicators of Early Nonalcoholic Fatty Liver Disease”

IDP-123 (tazarotene 0.045%) Lotion

• Draelos et al. “Comparison of a novel tazarotene 0.045% lotion to tazarotene 0.1% cream: patient-reported outcomes from a phase 2 clinical trial”

About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio includes several leading acne, anti-fungal and corticosteroid-responsive dermatoses products. More information can be found at www.ortho-dermatologics.com.

About Bausch Health
Bausch Health Companies Inc. (NYSE/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.

What is the most important information I should know about SILIQ?

Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms: new or worsening depression, anxiety, or mood problems; thoughts of suicide, dying, or hurting yourself; attempt to commit suicide, or acting on dangerous impulses; other unusual changes in your behavior or mood.

Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.

Please click here for full Prescribing Information for SILIQ, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

Please see full Prescribing Information for DUOBRII, BRYHALI and ALTRENO.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “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, risks and uncertainties discussed in the Company’s most recent annual or quarterly report and detailed from time to time in the Company’s other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including that the risks and uncertainties outlined above will not cause actual results or events to differ materially from those described in these forward-looking statements. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable, but 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.

ALTRENO, BRYHALI, DUOBRII and SILIQ are trademarks of Ortho Dermatologics’ affiliated entities.

© 2019 Ortho Dermatologics’ affiliated entities.
MTB.0444.USA.19

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SOURCE Bausch Health Companies Inc.

Company Codes: NYSE:BHC, Toronto:BHC