Bausch Health’s Ortho Dermatologics Business To Present New Scientific Data During The Fall Clinical Dermatology Conference

16 Poster Presentations Include New Evaluations of Investigational and Existing Products

LAVAL, Quebec, Oct. 15, 2018 /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 16 posters during the Fall Clinical Dermatology Conference in Las Vegas, Oct. 18-21. The presentations will feature new analyses of the investigational drug DUOBRII^TM1 (halobetasol propionate and tazarotene) (IDP-118) Lotion—including long-term evaluations of safety and maintenance of treatment success—as well as new data on SILIQ ™ (brodalumab) injection, ALTRENO^TM (tretinoin) Lotion, 0.05%, and BRYHALI^TM (halobetasol propionate) Lotion, 0.01%, which received tentative approval from the U.S. Food and Drug Administration (FDA) on Oct. 8, 2018. Please see below for SILIQ boxed warning about suicidal ideation and behavior.

“We are committed to researching and bringing forward innovative dermatology treatment options for the patients we serve,” said Bill Humphries, president, Ortho Dermatologics. “These new data presentations underscore the promise of our late-stage pipeline, as well as the strength of our robust and growing product portfolio, including SILIQ, BRYHALI Lotion and ALTRENO Lotion.”

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

DUOBRII^TM1 (halobetasol propionate and tazarotene) (investigational product IDP-118) Lotion

• Stein Gold et al. “Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis.”
• Yamauchi 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. “Long-Term Safety of a Fixed Combination Halobetasol Propionate 0.01% and Tazarotene 0.045% (HP/TAZ) Lotion in Moderate-to-Severe Plaque Psoriasis.”
• Pariser et al. “Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect after Cessation of Therapy.”
• Kircik et al. “A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Synergistic Effect of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis.”

BRYHALI^TM (halobetasol propionate) Lotion, 0.01%

• Sugarman et al. “Safety and Efficacy of Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies.”
• Kerdel et al. “A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Clinical Study to Compare the Safety and Efficacy of a Halobetasol Propionate 0.01% Lotion and Halobetasol Propionate 0.05% Cream in the Treatment of Plaque Psoriasis.”

SILIQ^TM (brodalumab) Injection

• Lebwohl et al. “Long-Term Efficacy of Brodalumab for the Treatment of Moderate-to-Severe Psoriasis in 2 Pivotal Phase 3 Clinical Trials.”
• Reich, Kristian, et al. “Brodalumab, a Human Anti-Interleukin-17 Receptor A Monoclonal Antibody, Shows Low Immunogenicity in Patients with Moderate-to-Severe Psoriasis.”
• Lebwohl, Mark, et al. “Malignancy Rates in the Brodalumab Psoriasis Clinical Studies.”
• Feldman, Steven, et al. “Distribution of Depression and Suicidality in a Psoriasis Clinical Trial Population.”

ALTRENO^TM (tretinoin) Lotion, 0.05%

• Kircik et al. “Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in an Adult and Adolescent Female Population.”
• Eichenfield et al. “Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in a Preadolescent Population.”
• Cook-Bolden et al. “Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in a Hispanic Population.”
• Zeichner et al. “Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Safety and Tolerability in Subgroups.”

FORMULATIONS

• Kircik et al. “Transepidermal Water Loss (TEWL) and Skin Hydration Assessment of a Novel Lotion Formulation.”

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 actinic keratosis, acne, atopic dermatitis, cold sores, athlete’s foot, nail fungus and other dermatoses. The Ortho Dermatologics portfolio includes several leading acne, antifungal 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, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

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.

DUOBRII, SILIQ, BRYHALI and ALTRENO are trademarks of Ortho Dermatologics’ affiliated entities.
© 2018 All Rights Reserved.
MTB.0498.USA.18

¹ Provisional Name

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SOURCE Bausch Health Companies Inc.

Company Codes: NYSE:BHC, Toronto:BHC