Data Sets Demonstrating Efficacy and Quality of Life Profile
of SILIQ Presented at 2017 Fall Clinical Dermatology
Conference
LAVAL, Quebec, Oct. 12, 2017 /PRNewswire/ -- Ortho
Dermatologics, a division of Valeant Pharmaceuticals International,
Inc. (NYSE: VRX and TSX: VRX), today announced results from the
Pivotal Phase 3 long-term extension study (AMAGINE-2), which
demonstrated that SILIQ™ (brodalumab) injection provided sustained
high levels of skin clearance (PASI 100) over more than two years
in patients with moderate-to-severe psoriasis. These findings are
being presented for the first time today at the 2017 Fall Clinical
Dermatology Conference in Las
Vegas.
"Over a two-year trial, a PASI 100 response rate was reached by
59 percent of a sub-analysis group of patients, demonstrating that
SILIQ is a long-term option to treat moderate-to-severe psoriasis,"
stated Alan Menter, M.D. "This is
highly important as patients always fear a flare-up of their
psoriasis after initial clearing."
SILIQ 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. SILIQ has a Black Box Warning
and a Risk Evaluation and Mitigation Strategy (REMS) due to
observed suicidal ideation and behavior in clinical trials. SILIQ
is contraindicated in patients with Crohn's disease. Serious
infections have occurred; therefore caution should be exercised
when considering the use of SILIQ in patients with a chronic
infection or a history of recurrent infection. Patients should be
evaluated for tuberculosis infection prior to initiating treatment
and avoid use of live vaccines.
"For patients with and without prior ustekinumab exposure, SILIQ
demonstrated improved skin clearance," said Lawrence J. Green, M.D., associate clinical
professor of Dermatology at George Washington
University School of Medicine in Washington, D.C. "More than 65 percent of both
ustekinumab-naïve and -experienced patients in AMAGINE-1 receiving
SILIQ treatment experienced complete clearance (PASI 100) at week
52, making this an excellent solution with proven results for a
wide range of patients with moderate-to-severe
psoriasis."
Dr. Lawrence Green will be
presenting additional information about SILIQ during a product
theatre titled, "A New Mechanism of Action in the Treatment of
Moderate-to-Severe Plaque Psoriasis" on Thursday, October 12th at 1pm – 2pm PT.
"I am pleased to see the durable efficacy of SILIQ demonstrated
through these additional findings," said Joseph C. Papa, chairman and CEO, Valeant. "This
dermatologic innovation has been shown to not only provide relief
for many patients who suffer from moderate-to-severe plaque
psoriasis, but also had an overall positive impact on the quality
of life of these patients."
Long-term Efficacy of Brodalumab for the Treatment of
Moderate-to-Severe Psoriasis Study (AMAGINE-2)
Results from
the long-term extension study (AMAGINE-2) found that SILIQ provided
sustained high levels of skin clearance (PASI 100) over more than
two years in those with moderate-to-severe psoriasis. Further, a
sub-analysis group of patients who received any dose of brodalumab
in the induction phase and SILIQ during the maintenance and
long-term extension (LTE) phases demonstrated similar response
rates. Patients who received either study dose of brodalumab in the
induction phase and SILIQ throughout the maintenance and LTE phases
at week 120, had a PASI 100 response rate of 59.0% (N=178), and
PASI 90 response rate of 76.4% (N=178). At week 52, the same set of
patients had a PASI 100 response rate of 63.4% (N=290) and PASI 90
response rate of 85.9% (N=290). At week 120, SILIQ continued to be
generally well-tolerated with a safety profile comparable to that
observed in the 52-week period.
Efficacy of Brodalumab in Ustekinumab-Naive and -Experienced
Patients With Moderate-to-Severe Plaque Psoriasis (AMAGINE-1)
Study
Results of a phase III, multicenter, randomized,
double-blind, placebo-controlled study (AMAGINE-1) of the efficacy
of brodalumab in a subset of patients with prior exposure to
ustekinumab, demonstrated that SILIQ was similarly efficacious with
improved skin clearance in patients both with and without prior
ustekinumab exposure. Among patients receiving continuous
SILIQ, rates of 100% reduction in PASI score (PASI 100) was 65.2%
(43 of 66) and 76.5% (n=13 of 17) in ustekinumab-naive and
-experienced patients at week 52, respectively. PASI 90 were 75.8%
(50 of 66) in ustekinumab-naive and 88.2% (15 of 17), in
ustekinumab-experienced patients.
Impact of Brodalumab Treatment on Psoriasis Symptom Severity
and Improvements in Health-Related Quality of Life
Study
Psoriasis symptoms have a significant negative impact
on health-related quality of life, impairing physical functioning
and well-being. Previously, data has shown that treatment with
SILIQ provided rapid improvement in Psoriasis Area and Severity
Index (PASI) and psoriasis symptoms in patients with
moderate-to-severe psoriasis. This improvement with SILIQ can also
be demonstrated by comparing baseline data with measurements at
week 12 in terms of improvement in psoriasis symptom inventory
scores (PSI) and Dermatology Quality of Life Index (DLQI) scores,
which are highly correlated. Additionally, an improvement in
psoriasis symptoms inventory score correlated with decreased PASI
scores with SILIQ treatment.
About SILIQ
In February 2017, the U.S. Food and
Drug Administration (FDA) approved the Biologics License
Application (BLA) for SILIQ, a novel human monoclonal antibody that
binds to the interleukin-17 (IL-17) receptor A and inhibits
inflammatory signaling by preventing the binding of several types
of IL-17 to the receptor. By blocking IL-17 from activating the
receptor, SILIQ prevents the body from receiving signals that may
lead to inflammation. The IL-17 pathway plays a central role in
inducing and promoting inflammatory disease processes.
In August 2015, Valeant entered
into a collaboration agreement with AstraZeneca (AZN.LN, NYSE:AZN,
AZN:SSE) granting Valeant an exclusive license to develop and
commercialize SILIQ globally, except in Japan and certain other Asian countries where
rights are held by Kyowa Hakko Kirin Co., Ltd. In July 2016, AstraZeneca and Valeant amended
Valeant's license for brodalumab to terminate Valeant's right to
develop and commercialize brodalumab in Europe. LEO Pharma currently holds exclusive
rights to develop and commercialize brodalumab in Europe, and Valeant holds the license to
develop and commercialize SILIQ in the U.S and other territories,
other than Japan and certain other
Asian countries.
About Ortho Dermatologics
Ortho Dermatologics is one
of the largest prescription dermatology businesses in the world
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, anti-fungal and anti-infective products. More
information can be found at www.ortho-dermatologics.com.
Important Safety Information
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.
Serious Infections: SILIQ may lower the ability of your
immune system to fight infections and may increase your risk of
infections.
- Your healthcare provider should check you for tuberculosis (TB)
before starting treatment with SILIQ and may treat you for TB
before starting SILIQ if you have TB or a history of it
- You and your healthcare provider need to watch closely for
signs and symptoms of infection during treatment with SILIQ,
including fever, sweats, chills, shortness of breath, stomach
issues, muscle aches, cough, sore throat or trouble swallowing,
warm/red painful skin sores, burning while urinating or more
frequent urination
Who should not use SILIQ?
Do not use SILIQ if you have Crohn's disease. Tell your
healthcare provider if you develop diarrhea, bloody stools, stomach
pain or cramping, sudden or uncontrollable bowel movements, loss of
appetite, constipation, weight loss, fever or tiredness as these
may be symptoms of Crohn's disease.
Before starting SILIQ, tell your healthcare provider if
you:
- have a history of mental health problems, including suicidal
thoughts, depression, anxiety, or mood problems
- have an infection that does not go away or keeps coming
back
- have TB or have been in close contact with someone with TB
- have recently received or are scheduled to receive an
immunization (vaccine). You should avoid getting live vaccines
while being treated with SILIQ
- are or plan to become pregnant, or are breastfeeding or plan to
do so. It is unknown if SILIQ can harm your unborn or newborn
baby
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
How should I use SILIQ?
See the detailed "Instructions for Use" that come
with your SILIQ for information on the right way to store, prepare,
and give your SILIQ injections at home, and how to properly throw
away (dispose of) used SILIQ prefilled syringes. Use SILIQ exactly
as your healthcare provider tells you to use it.
What are possible side effects of SILIQ?
SILIQ may cause serious side effects. See "What is the most
important information I should know about SILIQ?" and "Who should
not take SILIQ?"
The most common side effects of SILIQ
include:
Joint
pain Headache Tiredness Diarrhea Mouth or
throat pain Nausea
|
Muscle
pain Injection site
reactions Flu Low white
blood cell count (neutropenia) Fungal infections of the skin
|
|
|
Call your doctor for medical advice on side effects. You are
encouraged to report negative side effects of prescription drugs to
FDA at www.fda.gov/MedWatch or call
1-800-FDA-1088.
Forward-looking Statements
This press 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
Valeant's other filings with the Securities and Exchange Commission
and the Canadian Securities Administrators, which factors are
incorporated herein by reference. 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.
Valeant undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this press release or to reflect actual outcomes,
unless required by law.
Please call 1-800-321-4576 for full Prescribing Information,
including Black Box Warning about suicidal ideation and behavior,
or visit www.siliq.com
SILIQ is a trademark of Valeant Pharmaceuticals
International, Inc. or its affiliates.
Any other
product/brand names are trademarks of the respective
owners.
© 2017 Valeant Pharmaceuticals North America
LLC.
SLQ.0176.USA.17
Contact
Information:
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Media
Contact:
|
Arthur
Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
514-856-3855
|
908-927-0617
|
877-281-6642 (toll
free)
|
|
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SOURCE Valeant Pharmaceuticals International, Inc.