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28-Feb-2019

Ortho Dermatologics To Present New Analyses At The American Academy Of Dermatology Annual Meeting

 

10 Poster Presentations Include New Analyses of Phase 3 Data on Investigational Drug DUOBRII™1 and SILIQ™ 

LAVAL, Quebec, Feb. 28, 2019 /PRNewswire/ -- Ortho Dermatologics, one of the largest prescription dermatology health care businesses, and its parent company, Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced the presentation of 10 posters during the American Academy of Dermatology Annual Meeting in Washington, D.C., March 1-5, 2019.

Five presentations will feature new analyses of Phase 3 data on DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) Lotion, an investigational drug awaiting NDA approval. An additional five presentations will include new subgroup analyses of Phase 3 data on SILIQ™ (brodalumab) injection, which examine the safety and efficacy of SILIQ in patients of varying age, disease duration and treatment experience. See below for SILIQ boxed warning about suicidal ideation and behavior.

"We look forward to sharing these important new data on our investigational treatment, DUOBRII, as well as the new data on SILIQ," said Bill Humphries, president, Ortho Dermatologics. "We remain committed to continually studying both our investigational as well as inline therapies to help bring novel products to market and better inform dermatologists so that they can make the best treatment decisions for their patients."

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

DUOBRII™1 (halobetasol propionate and tazarotene) (investigational product IDP-118) Lotion

  • Stein Gold 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"
  • 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 2 Phase III Randomized Controlled Trials"
  • Yamauchi et al. "Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis in a Hispanic Population"
  • Blauvelt et al. "Efficacy of a Halobetasol and Tazarotene Lotion for Plaque Psoriasis Utilizing IGAxBSA Measurements"
  • Lebwohl et al. "Efficacy, Safety and Tolerability of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in the Treatment of Severe Plaque Psoriasis: Post Hoc Analysis of 2 Phase III Randomized Controlled Trials"

SILIQ™ (brodalumab) Injection

  • Blauvelt et al. "Improvements in Skin Clearance and Patient-Reported Signs and Symptoms of Psoriasis with Brodalumab: Pooled Analysis of Phase 3 Clinical Studies"
  • Lebwohl et al. "Brodalumab in Patients With Psoriasis Ages <65 and ≥65 Years: 120-Week Findings from Two Phase 3 Studies"
  • Gottlieb et al. "Long-term Efficacy and Safety of Brodalumab by Duration of Psoriasis: Analysis of Two Phase 3 Studies"
  • Green et al. "Brodalumab in Patients With or Without Previous Use of Biologic Agents: Long-term Findings from Two Phase 3 Psoriasis Studies"
  • Alexis et al. "Assessing the Relationship Between Skin Clearance and Symptom-Free Days in Patients With Psoriasis: Analysis of Clinical Studies of Brodalumab"

About Psoriasis
Psoriasis is an immune-mediated disease that speeds up the life cycle of skin cells, causing them to build up rapidly on the surface of the skin. The extra skin cells form raised, red, scaly patches that are itchy and sometimes painful.1 People with psoriasis are also reported to be at increased risk of developing other serious clinical conditions such as cardiovascular and other noncommunicable diseases and to suffer substantial impairment of physical and psychological quality of life.2 Plaque psoriasis is the most common type of psoriasis.3

What is SILIQ?
SILIQ injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:

  • who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment)
    and
  • who have tried another systemic therapy that didn't work or stopped working

It is not known if SILIQ is safe and effective in children.

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.

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.

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.

References

  1. Mayo Clinic. (2017). Psoriasis. Retrieved from https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840. Accessed February 6, 2018.
  2. World Health Organization. (2016). Global Report on Psoriasis. Retrieved from http://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf;jsessionid=81463A56C4318AF777E56018DB67B563?sequence=1. Accessed February 6, 2018.
  3. National Psoriasis Foundation. About Psoriasis. Retrieved from https://www.psoriasis.org/about-psoriasis. Accessed March 30, 2018.

DUOBRII and SILIQ are trademarks of Ortho Dermatologics' affiliated entities. Any other product/brand names are trademarks of the respective owners. © 2019 All Rights Reserved. MTB.0111.USA.19

1 Provisional Name

Investor Contact:
Arthur Shannon
arthur.shannon@bauschhealth.com  
(514) 856-3855   
(877) 281-6642 (toll free)

Media Contact:
Lainie Keller
lainie.keller@bauschhealth.com  
(908) 927-0617

 

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Last Updated: 28-Feb-2019