LAVAL, Quebec, Dec. 8, 2016 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)
("Valeant") today announced positive results from a Phase 3,
multicenter double-blind, randomized, vehicle-controlled clinical
study to assess the safety and efficacy of IDP-118 (halobetasol
propionate and tazarotene) lotion in the treatment of plaque
psoriasis.
Within the Phase 3 study of 215 adult subjects with moderate to
severe psoriasis, IDP-118 showed statistical significance to
vehicle with a treatment success rate of 45.33% and a
p<0.001. The primary endpoint of the 12-week study was
achievement of a "clear" to "almost clear" score based on an
Investigator Global Assessment (IGA) at 8 weeks, and at least 2
grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary
endpoints.
"We are pleased to share the positive results from the Phase 3
study of this important new formulation," stated Joseph C. Papa, Chairman and Chief Executive
Officer. "Psoriasis is often difficult to treat, and dealing
with this life-long condition can significantly impact a patient's
quality of life. Valeant remains committed to continued
research into innovative new treatments to improve the lives of
those who suffer from psoriasis."
While halobetasol propionate and tazarotene are both approved
and used to treat plaque psoriasis, each has certain attributes
that can influence the treatment duration owing to potential
adverse events. Based on existing data from our clinical
studies, the combination of these ingredients in IDP-118 with a
dual mechanism of action potentially allows for expanded use of
these active ingredients with reduced adverse events.
The Phase 3 program was preceded by a successful Phase 2 study
where the combination product IDP-118, with a treatment success
rate of 52.5%, was superior to each of the actives halobetasol
propionate and tazarotene as well as the vehicle. Valeant expects
to have data from a second confirmatory pivotal Phase 3 study in
2017.
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
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.