Dermatology Unit Is Rebranded Ortho Dermatologics
LAVAL, Quebec, July 27, 2017 /CNW/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced the launch of SILIQ™ (brodalumab) Injection during the
Summer American Academy of
Dermatology (AAD) meeting taking place in New York from July
27-30, 2017. SILIQ, a monoclonal antibody that targets
the IL-17 receptor A, 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.
"With the availability of SILIQ, physicians have a novel,
efficacious treatment option for their adult patients who
suffer from moderate-to-severe plaque psoriasis, which can be a
truly debilitating, incurable condition," said Joseph C. Papa, chairman and CEO, Valeant.
"Additionally, Valeant has priced SILIQ as the lowest-priced
injectable biologic psoriasis treatment in the United States and will work closely with
payers to ensure patients have the best possible access to this
important new treatment option."
SILIQ has a Black Box Warning for risks of suicidal ideation and
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 occurred in patients
treated with SILIQ. 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.
"As the first and only IL-17 receptor A blocker, SILIQ is the
only product on the market that demonstrated 100 percent
improvement in the psoriasis area and severity index (PASI 100)
during the clinical trials as a primary endpoint. In the three
clinical trials that have been completed, more than 50 percent of
patients who used SILIQ achieved total skin clearance within a
year," noted Lawrence J. Green,
M.D., assistant clinical professor of Dermatology at George Washington University School of Medicine
in Washington, D.C. "For my patients that have been suffering
with moderate-to-severe plaque psoriasis, having SILIQ as an
accessible treatment option will make a difference in their
day-to-day lives."
Valeant also announced today that its dermatology unit will be
renamed Ortho Dermatologics, effective immediately, under the new
senior leadership team lead by Bill
Humphries, executive vice president and company group
chairman, Ortho Dermatologics.
"The launch of SILIQ is a fitting demonstration of our
dermatologic innovation and strong commitment to physicians and
their patients. Not only are we bringing a product to market that
fulfills a significant unmet medical need, but the pricing of SILIQ
continues to show our commitment to making our medicines affordable
for the patients who need them," said
Humphries. "Historically, Ortho Dermatologics was known for
high connectivity and partnership with physicians throughout their
entire career, and we look forward to continuing to build upon this
long-standing legacy."
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., Canada 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 Ortho Dermatologics
Ortho Dermatologics, a
Valeant Pharmaceuticals International, Inc. company, 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.
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.
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.
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.
Contact Information:
Arthur Shannon
arthur.shannon@valeant.com
514-856-3855
877-281-6642 (toll free)
Media Contact:
Lainie
Keller
lainie.keller@valeant.com
908-927-0617
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SOURCE Valeant Pharmaceuticals International, Inc.