Ortho Dermatologics to Present New Data at the 2022 Innovations in Dermatology Conference

Rhea-AI Summary

Bausch Health Companies (NYSE:BHC) and its dermatology division, Ortho Dermatologics, announced the presentation of nine posters at the Innovations in Dermatology Conference on Nov. 3-5, 2022, in Las Vegas. The posters will highlight new analyses of JUBLIA (efinaconazole) and SILIQ (brodalumab), along with encore presentations of DUOBRII and ARAZLO. Ortho Dermatologics aims to engage with dermatologists and provide insights on their products, including the recently recognized JUBLIA, which received the APMA Seal of Approval.

Nine Poster Presentations Include New Analyses of SILIQ® and JUBLIA®

LAVAL, QC / ACCESSWIRE / November 1, 2022 / - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health") and its dermatology business, Ortho Dermatologics, today announced the presentation of nine posters during the Innovations in Dermatology Conference, which takes place Nov. 3-5, 2022, in Las Vegas, Nev. The presentations will feature new data around JUBLIA® (efinaconazole) Topical Solution, 10%, and SILIQ® (brodalumab) Injection, 210 mg/1.5 mL. There will also be six encore presentations, including analyses of DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, ARAZLO® (tazarotene) Lotion, 0.045%, and the investigational medicine IDP-126 Gel-a combination retinoid, antibacterial and antibiotic topical.

"Continued research around our products is a top priority for us at Ortho Dermatologics to ensure our portfolio meets the needs of patients," said Richard Lajoie, vice president and general manager, Ortho Dermatologics. "At this year's Innovations in Dermatology Conference, we look forward to the opportunity to directly engage with dermatologists and share new data on JUBLIA®, which received the APMA Seal of Approval in December 2021, as well as our biologic psoriasis medication, SILIQ®. "

The complete list of Ortho Dermatologics' poster presentations is as follows:

JUBLIA® (efinaconazole) Topical Solution, 10%

• "Combination Therapy With Efinaconazole for the Treatment of Toenail Onychomycosis." Lipner et al.
• "Therapeutic Recommendations for the Treatment of Toenail Onychomycosis in the US." Lipner et al.

SILIQ® (brodalumab) Injection, 210 mg/1.5 mL

• "Brodalumab Provides Rapid Onset of Therapeutic Response for Patients With Moderate-to-Severe Psoriasis." Armstrong et al.
• "Long-term Skin Clearance Achieved in Moderate-to-Severe Psoriasis Through Interleukin-17 Receptor A Blockade." Lain et al.
• "Brodalumab: 4-Year US Pharmacovigilance Report." Lebwohl et al.

ARAZLO® (tazarotene) Lotion, 0.045%

• "Tazarotene 0.045% Lotion for Truncal Acne: Efficacy, Tolerability, and Spreadability." Kircik et al.

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

• "Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for the Treatment of Plaque Psoriasis in Patients With Affected Body Surface Area of 3% to 5% and Poor Quality of Life." Stein Gold et al.
• "Importance of Topical Vehicle Design for the Treatment of Psoriasis: A Review of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion." Stein Gold et al.

IDP-126 Gel (Investigational Drug)

• "Efficacy and Safety of a Fixed-Dose Clindamycin 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: Randomized Phase 2 and Phase 3 Studies of the First Triple-Combination Drug." Stein Gold et al.

Important Safety Information for JUBLIA® (efinaconazole) Topical Solution, 10%

INDICATION

JUBLIA (efinaconazole) Topical Solution, 10% is a prescription medicine used to treat fungal infections of the toenails.

IMPORTANT SAFETY INFORMATION

• JUBLIA is for use on nails and surrounding skin only. Do not use JUBLIA in your mouth, eyes, or vagina. Use it exactly as instructed by your doctor.
• The safety and efficacy of JUBLIA have not been established in children under six years old.
• Before you use JUBLIA, tell your doctor about all your medical conditions, including if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed, because it is not known whether JUBLIA can harm an unborn fetus or nursing infant.
• Tell your doctor about all medications you are taking, and whether you have any other nail infections.
• JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
• JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your doctor about any side effects that bother you or do not go away.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information, including Patient Information.

Visit www.JubliaRx.com to learn more.

Important Safety Information for SILIQ® (brodalumab) Injection, 210 mg/1.5 mL

What is SILIQ?
SILIQ (brodalumab) injection is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

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.

This is not all the Important Safety Information you need to know about SILIQ. Please click here for full Prescribing Information for SILIQ, including Boxed Warning about suicidal ideation and behavior, and Medication Guide.

Important Safety Information for ARAZLO® (tazarotene) Lotion, 0.045%

What is ARAZLO?

ARAZLO^® (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.

It is not known if ARAZLO is safe and effective in children under 9 years of age.

Important Safety Information

ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.

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

• ARAZLO may cause birth defects if used during pregnancy.
• You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
• Use effective birth control during treatment.
• Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.

Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:

• have eczema or any other skin problems.
• are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure.

Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.

What should I avoid while using ARAZLO?

• You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
• Minimize exposure to sunlight; you could get severe sunburn.

If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.

• Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.

ARAZLO may cause side effects, including:

Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.

These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information, including Patient Information.

Important Safety Information for DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%

DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. It is not known if DUOBRII Lotion is safe and effective in children.

DUOBRII Lotion is for use on the skin only; do not use it in your mouth, eyes, or vagina.

DUOBRII Lotion may cause birth defects if used during pregnancy.

Stop using DUOBRII Lotion and tell your healthcare provider right away if you become pregnant while using DUOBRII Lotion.

DUOBRII may cause side effects, including:

• If too much DUOBRII passes through your skin it can cause adrenal glands to stop working
• Cushing's syndrome, a condition from too much exposure to the hormone cortisol
• High blood sugar (hyperglycemia)

The most common side effects of DUOBRII Lotion include redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

This is not all of the Important Safety Information you need to know about DUOBRII; please click here for full Prescribing Information, including Patient Information.

About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription and aesthetic dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis,onychomycosis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio also includes several leading medical device systems for aesthetic applications, such as skin tightening and resurfacing, laser hair removal and preventative therapeutic skin care treatments. More information can be found at www.ortho-dermatologics.com.

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "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 Bausch Health'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 Bausch Health, including but not limited to its project development timelines, launches 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.

Contact:

Bausch Health Investor Contact:
Christina Cheng
ir@bauschhealth.com

Bausch Health Media Contact:
Kevin Wiggins
corporate.communications@bauschhealth.com

JUBLIA, SILIQ, ARAZLO, and DUOBRII are trademarks of Ortho Dermatologics' affiliated entities.
Ortho Dermatologics is a trademark of Ortho Dermatologics' affiliated entities.

© 2022 Ortho Dermatologics' affiliated entities.
ORD.0140.USA.22

SOURCE: Bausch Health Companies Inc

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FAQ

What presentations will Bausch Health showcase at the Innovations in Dermatology Conference 2022?

Bausch Health will showcase nine poster presentations including new analyses of JUBLIA and SILIQ, along with encore presentations of DUOBRII and ARAZLO.

When is the Innovations in Dermatology Conference where Bausch Health will present?

The Innovations in Dermatology Conference will take place from November 3-5, 2022.

What is JUBLIA and why is it significant for Bausch Health?

JUBLIA (efinaconazole) is a topical solution for toenail fungal infections and recently received the APMA Seal of Approval, marking its importance in Bausch Health's portfolio.

What is the primary focus of Bausch Health's dermatology business, Ortho Dermatologics?

Ortho Dermatologics focuses on treating various dermatological conditions, including psoriasis and onychomycosis, through innovative treatments.

What is the significance of the analyses presented for SILIQ?

The analyses for SILIQ (brodalumab) will highlight its rapid therapeutic response and long-term skin clearance for moderate-to-severe psoriasis.