Revance Announces Completion of Pre-Phase 3 Meeting with FDA for RT002 Injectable to Treat Glabellar Lines
July 14 2016 - 4:02PM
Business Wire
- Company plans to initiate global Phase 3
program in the second half of 2016 -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced the completion of its
Type B / pre-IND / pre-Phase 3 meeting with the U.S. Food and Drug
Administration (FDA) regarding DaxibotulinumtoxinA for Injection
(RT002) for the treatment of glabellar (frown) lines. Based upon
the discussion with the FDA and the minutes received following the
meeting, Revance is moving forward with an Investigational New Drug
(IND) submission for the Phase 3 clinical program for RT002 in
glabellar lines and other supportive studies required for Biologics
License Application (BLA) filing. Revance expects to initiate its
Phase 3 clinical trials in the second half of 2016.
The company’s Phase 3 program will include two
placebo-controlled pivotal studies conducted at multiple sites in
the US and Canada. The primary endpoint of these studies will be a
composite of the proportion of subjects who achieve a score of 0 or
1 (none or mild) and a two-point improvement from baseline in
glabellar line severity on investigator assessment (IGS-FWS) and
patient assessment (PFWS) scales, at maximum contraction (frown),
at Week 4. Duration of the reduction of severity of the glabellar
lines will be assessed as a secondary endpoint in the Phase 3
pivotal studies. In addition, the Phase 3 program will include a
long-term, open-label safety study. Revance plans to announce
additional details on the study designs when the company begins
dosing patients.
“We have been very pleased by the informative and productive
discussions with the FDA and our ability to reach agreement on
appropriate next steps for our pivotal frown line program,” said
Dan Browne, President and Chief Executive Officer of Revance. “The
design of our Phase 3 program is consistent with the FDA ‘Draft
Guidance for Industry: Upper Facial Lines’. We are finalizing the
IND submission for the glabellar line program and have already
begun study start-up activities.”
About Glabellar Lines
The glabella is the skin between the eyebrows and above the
nose. Glabellar lines (often called “frown lines”) are those
vertical lines that develop between the eyebrows and may appear as
a single vertical line or as two or more lines and may also appear
angled towards the inner corners of the eyebrows. When you frown,
the muscles of the lower forehead contract in a downward direction
causing the skin between the eyebrows to crease. Lines are formed
by the repeated action of frowning due to the lack of elasticity in
the skin. Age, sun exposure, and genetics are contributing factors.
Botulinum toxin is used to block the nerve impulses, temporarily
paralyzing the muscles that cause the frown lines, giving the skin
a smoother, more refreshed appearance.
Based on data from UBS Global Research, the global market for
aesthetic treatments with neurotoxins represented about a $1.4
billion market in 2014, and according to the American Society for
Aesthetic Plastic Surgery, botulinum toxin treatment is the number
one nonsurgical cosmetic procedure in the United States. Glabellar
line treatment represents the largest segment of that market.
About Revance Therapeutics, Inc.
Revance, a Silicon Valley-based biotechnology company, is
committed to the advancement of remarkable science. The company is
developing a portfolio of products for aesthetic medicine and
underserved therapeutic specialties, including dermatology and
neurology. Revance’s trajectory to commercial success begins with
the company’s novel and proprietary TransMTS® carrier-peptide
delivery system applied to botulinum toxin.
Revance is developing daxibotulinumtoxinA, the company’s highly
purified botulinum toxin, for a broad spectrum of aesthetic and
therapeutic indications, including facial wrinkles and muscle
movement disorders.
The company holds worldwide rights for all indications of
DaxibotulinumtoxinA Topical Gel (RT001), DaxibotulinumtoxinA for
Injection (RT002) and the TransMTS technology platform. Beyond
botulinum toxin, Revance believes the TransMTS technology can be
applied to transdermal, mid-dermal, or deep tissue delivery of a
variety of other macromolecules. More information on Revance can be
found at www.revance.com.
"Revance Therapeutics", TransMTS®, “Remarkable Science Changes
Everything”, and the Revance logo are registered trademarks of
Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to: statements about our investigational
drug product candidates and planned studies and related activities,
expected efficacy of our drug product candidates, clinical
development, timeline and other goals and market for our
anticipated products, plans and prospects and statements about
potential benefits of our drug product candidates and our
technologies.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from our expectations. These risks and uncertainties include, but
are not limited to: the outcome, cost, and timing of our product
development activities and clinical trials; the uncertain clinical
development process, including the risk that clinical trials may
not have an effective design or generate positive results; our
ability to obtain and maintain regulatory approval of our drug
product candidates; our ability to obtain funding for our
operations; our plans to research, develop, and commercialize our
drug product candidates; our ability to achieve market acceptance
of our drug product candidates; unanticipated costs or delays in
research, development, and commercialization efforts; the
applicability of clinical study results to actual outcomes; the
size and growth potential of the markets for our drug product
candidates; our ability to successfully commercialize our drug
product candidates and the timing of commercialization activities;
the rate and degree of market acceptance of our drug product
candidates; our ability to develop sales and marketing
capabilities; the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for financing; our
ability to continue obtaining and maintaining intellectual property
protection for our drug product candidates; and other risks.
Detailed information regarding factors that may cause actual
results to differ materially from the results expressed or implied
by statements in this press release may be found in Revance's
periodic filings with the Securities and Exchange
Commission (the "SEC"), including factors described in the
section entitled "Risk Factors" of our quarterly report on Form
10-Q filed on May 10, 2016. These forward-looking statements speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160714006320/en/
Investors:Revance TherapeuticsJeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellanAmi Bavishi,
212-213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Revance Therapeutics (NASDAQ:RVNC)
Historical Stock Chart
From Apr 2023 to Apr 2024