Novel Investigational Topical Lotion with Unique
Formulation Targets the Treatment of Plaque
Psoriasis
LAVAL,
Quebec, Sept. 5, 2017
/CNW/ -- Ortho Dermatologics, a division of Valeant
Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today
announced it has
submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (
FDA ) for IDP-118 (halobetasol
propionate and tazarotene) lotion . IDP-118 is the
first and only topical lotion that contains a
unique combination of halobetasol propionate and tazarotene
for the treatment of plaque psoriasis.
"We are greatly encouraged by the efficacy and safety
results of the IDP-118 clinical program and proud of the dedication
of our medical and R&D teams who were able to expedite the NDA
filing ahead of internal expectations for this promising
treatment," said Joseph C.
Papa, chairman and CEO, Valeant.
"This submission reflects our unwavering commitment to
investing in our pipeline to bring forward novel treatment
innovations that help improve the lives of our customers and their
patients."
Both approved to treat plaque psoriasis, halobetasol
propionate and tazarotene, when used separately, are limited to a
four-week or less duration of use. Based on
existing data from clinical studies, the combination of these
ingredients in IDP-118 with a dual mechanism of action, potentially
allows for expanded duration of use, with reduced adverse
events.
The NDA submitted for IDP-118 includes data from two
successful Phase 3 multi-center, randomized, double-blind clinical
trials in 418 subjects 18 years of age and older with 3%-12%
clinical involvement of the body surface area for plaque
psoriasis. In both studies, IDP-118 met
the primary efficacy endpoint achieving a "clear" to
"almost clear" score and at least a 2 grade improvement based on an
Investigator Global Assessment (IGA) at 8 weeks, and clear to
almost clear and at least 2 grade improvement during a 4 week
follow up visit at week 12. The NDA also includes a long-term
safety study with patients followed for one year. The most common
adverse events were contact dermatitis (7.4%) and application site
pain (2.6%).
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, which
demonstrates the IDP-118 formulation is superior to using the
individual actives separately.
About Ortho Dermatologics
Ortho
Dermatologics, aValeant Pharmaceuticals
International, Inc. company, is one of the
largest prescription dermatology companies in the world dedicated
to helping patients in the treatment of a range of therapeutic
areas including actinic keratosis, acne, atopic dermatitis,
psoriasis, 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.
Contact Information:
|
Media Contact:
|
Arthur Shannon
|
Lainie
Keller
|
arthur.shannon@valeant.com
|
lainie.keller@valeant.com
|
514-856-3855
|
908-927-0617
|
877-281-6642 (toll
free)
|
|
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SOURCE Valeant Pharmaceuticals International, Inc.