Committee to Review Valeant's BLA 761032 Brodalumab
Subcutaneous Injection For Treatment of Adult Patients with
Moderate to Severe Plaque Psoriasis
LAVAL, Quebec, June 9, 2016 /CNW/ -- Valeant Pharmaceuticals
International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant" or the
"Company") today announced that it has received notification from
the U.S. Food and Drug Administration (FDA) that the Dermatologic
and Ophthalmic Drugs Advisory Committee will review Valeant's New
Drug Application (NDA) for brodalumab on July 19, 2016.
On January 25, 2016, Valeant
announced that the FDA had accepted for review the Biologics
License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE:
AZN) in partnership with Valeant for brodalumab injection, 210 mg,
a monoclonal antibody that targets the IL-17 receptor, in
development for patients with moderate to severe plaque psoriasis.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) action
date of November 16, 2016.
"Plaque psoriasis is a chronic disease of the immune system that
can impair many aspects of patients' lives," said Joseph C. Papa, chairman and chief executive
officer. "We look forward to the opportunity to discuss
brodalumab treatment options for adult patients with moderate to
severe plaque psoriasis and provide information about this novel
antibody we are developing."
As previously announced, the Marketing Authorisation Application
(MAA) for brodalumab in psoriasis was accepted by the European
Medicines Agency (EMA) in Q42015. In October, 2015, Valeant
entered into a collaboration agreement with AstraZeneca under which
Valeant has an exclusive license to develop and commercialise
brodalumab globally, except in Japan and certain other Asian countries where
rights are held by Kyowa Hakko Kirin Co., Ltd.
About brodalumab
Brodalumab is a novel human
monoclonal antibody that binds to the interleukin-17 (IL-17)
receptor and inhibits inflammatory signaling by blocking the
binding of several types of IL-17 to the receptor. By stopping
IL-17 from activating the receptor, brodalumab 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.
Safety Information
The most common adverse reactions
in the clinical development program were headache, arthralgia,
fatigue, oropharyngeal pain, and diarrhea. Suicidal ideation
and behavior and serious infections were reported in the clinical
trials.
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 disorder, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press release
contains forward-looking statements. Forward-looking
statements 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 and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those
described in the forward-looking statements. 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:
Laurie W.
Little
laurie.little@valeant.com
or
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.