SAKURA 3 Trial Results Presented on Podium at World’s Largest Medical Aesthetic Conference
April 8, 2019– Unprecedented clinical results for DaxibotulinumtoxinA for Injection
(DAXI), Revance’s long-acting neuromodulator, were highlighted at the 17th
Aesthetics & Anti-Aging Medical World Congress in Monte-Carlo –
NEWARK, Calif.–(BUSINESS WIRE)–Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company
developing next-generation neuromodulators for use in treating aesthetic
and therapeutic conditions, today announced podium and poster
presentations of its SAKURA 3 Phase 3 open-label, long-term safety study
of DaxibotulinumtoxinA for Injection (DAXI) for the treatment of
glabellar (frown) lines at the 17th Aesthetics & Anti-Aging Medical
World Congress (AMWC). The leading international conference was held
April 4 – 6 in Monte-Carlo, Monaco. SAKURA 3 was the culmination of the
largest aesthetic clinical program of an aesthetic neuromodulator, which
consistently demonstrated unprecedented efficacy, safety and duration
across 65 sites and 3,800 treatments. The SAKURA 3 trial was
specifically designed to evaluate the long-term safety of DAXI following
both single and repeat treatment administration in adults 18 years of
age and over.
“I was excited to present the SAKURA 3 study data on DAXI at the largest
aesthetics meeting in the world, with more than 2,000 people in
attendance,” said cosmetic dermatologic surgeon Sabrina Guillen-Fabi,
MD, of Cosmetic Laser Dermatology in San Diego, Calif. “Colleagues were
impressed with the consistent and predictable response rates, the safety
profile and, most importantly, the duration of effect.”
SAKURA 3 Podium Presentation
Results of a large
open-label safety study of DaxibotulinumtoxinA for Injection in
glabellar lines (Session: Botulinum Toxin: From Fundamental to
Expert Practice).
Presenter: Dr. Sabrina Guillen-Fabi
SAKURA 3 Poster Presentation
Results of a large
open-label safety study of DaxibotulinumtoxinA for Injection in
glabellar lines
Sabrina Guillen-Fabi, MD, Jeremy B Green, MD,
Yan Liu, Roman G Rubio, Conor J Gallagher
SAKURA 1 and 2 Pivotal Phase 3 Trial Poster Presentation
Pooled
results from two Phase 3 pivotal studies of DaxibotulinumtoxinA for
Injection in glabellar lines
Joely Kaufmann-Janette, MD, Nowell
Solish, MD, Yan Liu, Roman G Rubio, Conor J Gallagher
“We were delighted to have Dr. Sabrina Guillen-Fabi share the
exceptional results from the SAKURA 3 trial with a worldwide audience of
aesthetic and anti-aging experts,” said Dan Browne, president and chief
executive officer at Revance. “We will continue to share these results
at aesthetics conferences and through major medical journals while we
await potential U.S. regulatory approval next year. Revance plans to
launch DAXI as not only a premium product, but the first major
innovation in neuromodulators in 30 years, delivering enduring frown
line reduction with just two treatments a year.”
About Revance Therapeutics, Inc.
Revance Therapeutics is an emerging Silicon Valley biotechnology leader
developing neuromodulators for the treatment of aesthetic and
therapeutic conditions. Revance uses a unique proprietary peptide
excipient technology to create novel, differentiated therapies. The
company’s lead compound, DaxibotulinumtoxinA for Injection (DAXI), is in
clinical development for a broad range of aesthetic and therapeutic
indications, including glabellar lines, cervical dystonia, plantar
fasciitis, upper limb spasticity and chronic migraine. DAXI has the
potential to be the first long-acting neuromodulator. The company is
advancing a robust pipeline of injectable and topical formulations of
daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of
Revance Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements related to Revance Therapeutics’ current and anticipated
future clinical development and potential commercialization of our
investigational drug product candidates, including DAXI; statements
about our business strategy, timeline and other goals and market for our
anticipated products, plans and prospects; including our
pre-commercialization plans and commercial potential of our client
candidates; and statements about the benefits of, and our ability to
obtain regulatory approval with respect to our drug product candidates
and our excipient peptide and other 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, or that positive results would assure
regulatory approval or commercial success of our product candidates; 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 annual report on Form 10-K filed February 28, 2019.
These forward-looking statements speak only as of the date hereof.
Revance disclaims any obligation to update these forward-looking
statements.
Contacts
INVESTORS
Revance Therapeutics, Inc.:
Jeanie Herbert,
714-325-3584
[email protected]
or
Burns
McClellan, Inc.:
John Grimaldi, 212-213-0006
[email protected]
MEDIA
Nadine
Tosk, 504-453-8344
[email protected]
