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 DUOBRIITM1 (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, ALTRENOTM
(tretinoin) Lotion, 0.05%, and BRYHALITM (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.
DUOBRIITM1 (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."
BRYHALITM (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."
SILIQTM (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."
ALTRENOTM (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
Investor
Contact:
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