LAVAL, Quebec, April 21, 2017 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today
announced that following the evaluation and approval of its Patient
Access and Pricing Committee (PAPC), the company has decided to
list SILIQ™ (brodalumab) injection, at $3,500 per month, which is the lowest injectable
biologic psoriasis treatment currently on the market. SILIQ will
also be included in the company's patient access program to further
offer financial support and access to patients. SILIQ, a
monoclonal antibody that targets the IL-17 receptor for patients
with moderate-to-severe plaque psoriasis, 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 is the only product that included the
psoriasis area and severity index (PASI 100) during clinical trials
as a primary endpoint. The sales and marketing of SILIQ are
expected to commence in the U.S. during the second half of
2017.
"The Patient Access and Pricing Committee was constructed to
help our company ensure patients have the best possible access to
our products. Our goal with SILIQ is to provide outstanding
efficacy while being the most affordable injectable biologic for
patients with moderate-to-severe plaque psoriasis," said Joseph Papa, Chairman and CEO of Valeant.
In May 2016, Valeant established
the PAPC to be responsible for the pricing of the company's drugs.
The PAPC ensures that Valeant's pricing, contracting, compliance
and reimbursement strategies are consistent and compliant with all
relevant laws, regulations and guidance, as well as the company's
position on patient-affordable access to medicines. The Company's
Board of Directors oversees the committee, which is chaired by Papa
and includes a multi-disciplinary team of Valeant employees,
including doctors, scientists, and other executives.
SILIQ has a Black Box Warning for risk 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.
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 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.
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.
Contact Information:
Elif McDonald
514-856-3855
877-281-6642 (toll free)
elif.mcdonald@valeant.com
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
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SOURCE Valeant Pharmaceuticals International, Inc.