Launch Expected to Occur Later this Month Following
Final FDA Approval
LAVAL, Quebec, Nov. 7, 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 it expects to start distribution
of BRYHALI™ (halobetsasol propionate) Lotion, 0.01%, to
U.S. wholesale pharmaceutical distributors later this month. The
company received final approval from the U.S. Food and Drug
Administration (FDA) for BRYHALI Lotion on Nov. 6, 2018. BRYHALI Lotion, which is indicated
for the topical treatment of plaque psoriasis in adult patients, is
a new potent to superpotent corticosteroid in a novel vehicle
lotion with safety established for dosing up to eight
weeks.1
"We are proud of our efforts to make BRYHALI Lotion available as
quickly as possible following final approval by the FDA," said
Bill Humphries, president, Ortho
Dermatologics. "In doing so, our customers and their patients now
have a new topical treatment option that provides the efficacy of a
high-potency steroid with tolerability and longer duration of use.
We look forward to engaging physicians in their offices later this
month to discuss BRYHALI Lotion and its unique attributes to help
meet the needs of their patients."
BRYHALI Lotion had initially received a tentative approval from
the FDA due to the pending expiration of exclusivity for a related
product. The FDA approval of BRYHALI Lotion was based on data from
two prospective, multicenter, randomized, double-blind clinical
trials. In clinical trials, BRYHALI Lotion was applied once daily
for eight weeks and shown to be generally well-tolerated with no
increase in epidermal atrophy. In Study 1 and Study 2, 37 percent
and 38 percent of patients, respectively, treated with BRYHALI
Lotion achieved treatment success (at least a two-grade improvement
from baseline in Investigator's Global Assessment (IGA) and an IGA
score equating to "clear" or "almost clear") at eight weeks,
compared to eight percent and 12 percent of patients treated with
vehicle. Data from both trials showed that BRYHALI Lotion
demonstrated significant treatment success over vehicle as early as
week two (Study 1) and week four (Study 2), which continued through
12 weeks (four weeks post treatment). The most common adverse
reactions, occurring in ≥1 percent of subjects treated with BRYHALI
Lotion through week eight, were upper respiratory tract infection
(2 percent), application site dermatitis (1 percent) and
hyperglycemia (1 percent).1
"BRYHALI Lotion will help address an unmet need for many plaque
psoriasis patients," said Lawrence J.
Green, M.D., a lead investigator on the BRYHALI Lotion Phase
3 studies and associate clinical professor of Dermatology
at George Washington University
School of Medicine in Washington,
D.C. "Topical steroids are the most frequently used
treatment for psoriasis, but come with an increased risk of adverse
events and a duration of use limited to two to four weeks. With
BRYHALI Lotion, I'm excited to offer my patients a topical steroid
option that can be used for up to eight weeks without sacrificing
tolerability, and with proven efficacy."
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.2 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.3 Plaque psoriasis is the most common type of
psoriasis.4
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.
Important Safety Information for BRYHALI ™ (halobetasol
propionate) Lotion 0.01%
What is BRYHALI Lotion?
- BRYHALI™ Lotion is a prescription medicine used on the skin
(topical) to treat adults with plaque psoriasis. It is not known if
BRYHALI Lotion is safe and effective in children under 18 years of
age.
Important Safety Information
- BRYHALI Lotion is for use on skin only. Do not use BRYHALI
Lotion in your mouth, eyes, or vagina.
Before you use BRYHALI Lotion, tell your healthcare provider
about all your medical conditions, including if you:
- Have had irritation or other skin reaction to a steroid
medicine in the past
- Have a skin infection
- Have diabetes
- Have adrenal gland or liver problems
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed. It is not known if
BRYHALI Lotion passes into your breast milk. If you do breastfeed,
do not apply BRYHALI Lotion to your nipple or areola to avoid
getting it in your baby's mouth
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Especially tell your healthcare
provider if you take other corticosteroids by mouth or injection,
or use other products on your skin that contain
corticosteroids.
What are the possible side effects of BRYHALI
Lotion?
BRYHALI Lotion may cause serious side effects,
including:
- A condition where your adrenal glands stop working
- Cushing's syndrome, a
condition caused by too much exposure to the hormone cortisol
- High blood sugar (hyperglycemia)
- Skin reactions at the treated site
- Vision problems such as cataracts and glaucoma. Tell your
doctor about any blurred vision or other vision problems during
treatment
- Effects on growth and weight in children
The most common side effects of BRYHALI Lotion include:
burning, stinging, itching, dryness (application site dermatitis),
upper respiratory tract infection, and high blood sugar
(hyperglycemia).
These are not all the possible side effects of BRYHALI
Lotion.
Call your healthcare provider for medical advice about side
effects. You may report side effects to the FDA at
1-800-FDA-1088.
Please click here for full Prescribing Information.
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
- BRYHALI™ [prescribing information]. Bridgewater, NJ: Ortho Dermatologics.
- Mayo Clinic. (2017). Psoriasis. Retrieved from
https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840.
Accessed February 6, 2018.
- 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.
- National Psoriasis Foundation. About Psoriasis. Retrieved from
https://www.psoriasis.org/about-psoriasis. Accessed March 30, 2018.
BRYHALI is a trademark of Ortho Dermatologics' affiliated
entities.
© 2018 All Rights Reserved.
BRY.0084.USA.18
Investor
Contact:
|
Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@bauschhealth.com
|
lainie.keller@bauschhealth.com
|
(514)
856-3855
|
(908)
927-0617
|
(877) 281-6642 (toll
free)
|
|
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SOURCE Bausch Health Companies Inc.