LAVAL, Quebec, Feb. 16, 2017 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE & TSX: VRX) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the Biologics License Application (BLA) for SILIQ™
(brodalumab) injection, for subcutaneous use, a monoclonal antibody
that targets the IL-17 receptor for patients with
moderate-to-severe plaque psoriasis. 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. Valeant expects to commence sales and marketing of SILIQ
in the U.S. in the second half of 2017.
"We believe SILIQ fulfills a significant unmet medical need, and
I am proud of our team's success in developing and bringing to
market this treatment for patients with moderate-to-severe plaque
psoriasis," said Joseph C. Papa,
Chairman and CEO of Valeant. "We are pleased that SILIQ will soon
be available to help treat the suffering of adults who live with
this debilitating, incurable condition, and further our mission to
improve people's lives with our healthcare products."
SILIQ has a Black Box Warning for the risks in patients with a
history of suicidal thoughts or behavior. SILIQ was approved with a
Risk Evaluation and Mitigation Strategy (REMS) involving a one-time
enrollment for physicians and one-time informed consent for
patients. The most common adverse reactions were headache,
arthralgia, fatigue, oropharyngeal pain, and diarrhea. SILIQ is
contraindicated in patients with Crohn's disease. Suicidal
ideation and behavior have been reported. 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.
Plaque psoriasis is the most common type of psoriasis, a
chronic, noncommunicable, skin disease.1 The disease
alters the life cycle of skin cells, causing them to build up
rapidly on the surface of the skin. SILIQ works by binding to
IL-17RA with high affinity, therefore blocking the inflammatory
downstream activity of IL-17A, IL-17F, IL-17A/F heterodimer and
IL-17E. By targeting the IL-17 receptor, SILIQ prevents skin cells
from accumulating. In three clinical studies that have been
completed, more than 50% of patients who used SILIQ achieved total
skin clearance within a year.
"SILIQ is the only product that has demonstrated 100%
improvement in the psoriasis area and severity index (PASI 100)
during clinical trials as a primary endpoint," said Lawrence J. Green, M.D., associate clinical
professor of Dermatology at George Washington
University School of Medicine in Washington, D.C. "As the first IL-17 receptor
A blocker that helps stop the proinflammatory cascade that leads to
psoriasis, resulting in the normalization of skin inflammation,
this is a significant achievement for the many patients who suffer
with moderate-to-severe plaque psoriasis. SILIQ will be a
welcomed addition to my treatment armamentarium."
"As one of the millions of people who has lived with the pain
and stigma of this lifelong chronic condition, I am thrilled that
SILIQ will be available as a treatment option for patients
suffering with moderate-to-severe plaque psoriasis," said
Tena Brown, CEO of Tenacity
Consulting and Patient Advocate. "Achieving total skin clearance is
a major factor in improving quality of life for patients with
severe plaque psoriasis. I look forward to helping educate
physicians and patients about this important and effective new
treatment."
As previously announced, the Marketing Authorisation Application
(MAA) for brodalumab in moderate-to-severe psoriasis was accepted
by the European Medicines Agency (EMA) in the fourth quarter of
2015. In August 2015, Valeant entered
into a collaboration agreement with AstraZeneca (AZN.LN, NYSE:AZN)
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. In July
2016, brodalumab (marketed as LUMICEF) was granted approval
from the Ministry of Health, Labour and Welfare Japan.
About SILIQ
SILIQ is a novel human monoclonal antibody that binds to the
interleukin-17 (IL-17) receptor 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.
About Valeant
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, gastrointestinal disorders,
eye health, neurology and branded generics. More information about
Valeant can be found at www.valeant.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca.com and follow us on Twitter
@AstraZeneca.
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.
1 Source: Global Report on Psoriasis, World Health
Organization.
Contact Information:
Elif McDonald
elif.mcdonald@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
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SOURCE Valeant Pharmaceuticals International, Inc.
