Market Overview

Revance's RT002 Meets Primary and All Secondary Endpoints, Achieves 6-Month Duration in Pivotal SAKURA Phase 3 Trials for Glabellar Lines

Share:

– Highly statistically significant results on primary composite
endpoint achieved at Week 4 –

– RT002 delivered highly statistically significant reduction in
severity of glabellar lines at Week 24 –

– If approved, RT002 could represent a new, next-generation,
long-acting neuromodulator –

– Revance to host conference call at 8:00 am ET today –

Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, today announced its next-generation
neuromodulator DaxibotulinumtoxinA for Injection (RT002) delivered
positive top-line results in alleviating moderate-to-severe glabellar
lines in two pivotal SAKURA Phase 3 trials. RT002 appeared generally
safe and well-tolerated in both studies.

If approved by the U.S. Food and Drug Administration (FDA), Revance
believes RT002 would be the first neuromodulator with a long-acting
duration of six months. Marketed neuromodulators have demonstrated
duration of three to four months in treating glabellar lines.

Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by
delivering highly statistically significant improvement against placebo
in reducing the severity of glabellar lines, i.e., the frown lines or
wrinkles between the brows. The percent of RT002-treated patients who
had none or mild wrinkles and achieved at least a two-point improvement
from baseline on both validated physician and patient assessments were
73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to
placebo (p<0.0001) at Week 4. Also at that time point, 88 percent of
RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in
SAKURA 2 said they were very satisfied or satisfied with their treatment
experience.

All secondary endpoints measuring reduction in severity of glabellar
lines with RT002 compared to placebo were highly statistically
significant at every time point evaluated to 24 weeks. On an additional
key secondary endpoint, median duration for patients treated with RT002
to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1:
27.7 weeks and SAKURA 2: 26.0 weeks) as assessed by both physicians and
patients.

"We are extremely pleased with these positive SAKURA top-line results,
which reinforce the findings from the BELMONT Phase 2 active-comparator
study. These results demonstrate it is scientifically and clinically
possible to create a significantly longer-acting neuromodulator with a
duration of six months, compared to three to four months observed with
currently available products," said Dan Browne, Co-Founder, President
and Chief Executive Officer of Revance Therapeutics. "We look forward to
providing patients and healthcare professionals with what we believe is
a new, next-generation, long-acting neuromodulator for the treatment of
glabellar lines."

In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA
3, is fully enrolled and is expected to be completed in the second half
of 2018. Assuming successful completion of SAKURA 3, the company plans
to submit a Biologics License Application in the first half of 2019 and,
pending approval by the FDA, launch RT002 in the U.S. in 2020.

"Both SAKURA 1 and SAKURA 2 show RT002 delivers consistent long-acting
performance, which is unprecedented for a neuromodulator given what we
have seen over the last 30 years," said Jean D. Carruthers, M.D., a
SAKURA lead investigator and pioneer in the use of botulinum toxin for
both aesthetic and therapeutic conditions, and Clinical Professor,
University of British Columbia. "The data confirm the enhanced effect of
this new neuromodulator both in its longevity and patient response. With
just two treatments a year, RT002 has the potential to change the
landscape in neuromodulator therapy."

Treatment of glabellar lines is the most popular aesthetic procedure for
an injectable neuromodulator, accounting for nearly a third of the $3.6
billion in global neuromodulator sales in 2016. Patients and physicians
alike identify duration as the most important attribute of an injectable
aesthetic treatment, market research shows. 1

"Patients in my practice are very savvy – not only do they want their
neuromodulator treatment to give them great results, they also want the
look to last as long as possible," said Joely Kaufman-Janette, M.D.,
Skin Associates of South Florida, and a SAKURA investigator. "I am very
excited about the results of the SAKURA trials since RT002 appears to
provide the look my patients desire over a six-month period, which is
remarkable and will fulfill a significant need among my patients."

TOP-LINE 36-WEEK RESULTS

PRIMARY ENDPOINT

The primary efficacy measurement was a composite of the proportion of
patients who achieved a score of 0 or 1 (none or mild) and at least a
two-point improvement from baseline at maximum contraction (frown) in
glabellar line severity on both the Investigator Global
Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle
Severity (PFWS) scales at Week 4.

  • Percent of patients who achieved the primary composite endpoint:
    • SAKURA 1: 73.6 percent of patients vs. 0 percent for placebo
      (p<0.0001)
    • SAKURA 2: 74.0 percent vs. 1.0 percent for placebo (p<0.0001)

SECONDARY DURATION ENDPOINTS

There were several secondary endpoints used to evaluate duration of
effect, including the proportion of patients achieving none or mild
response on IGA-FWS compared to placebo, median duration for time to
loss of none or mild wrinkle severity on both IGA-FWS and PFWS, and
median duration for time to return to baseline on both IGA-FWS and PFWS.

  • The percent of patients treated with RT002 who achieved a none or mild
    response on IGA-FWS at Week 24:
    • SAKURA 1: 35.3 percent vs. 2.0 percent for placebo (p<0.0001)
    • SAKURA 2: 29.4 percent vs. 2.0 percent for placebo (p<0.0001)
  • Median duration for time to loss of none or mild wrinkle severity on
    both IGA-FWS and PFWS for patients treated with RT002:
    • SAKURA 1: 24.0 weeks
    • SAKURA 2: 23.9 weeks
  • Median duration for time to return to baseline wrinkle severity on
    both IGA-FWS and PFWS for patients treated with RT002:
    • SAKURA 1: 27.7 weeks
    • SAKURA 2: 26.0 weeks

For comparison, an additional exploratory duration endpoint was
evaluated, which mirrors the duration measure used in the BELMONT Phase
2 study.

  • Median duration of ≥ 1 point improvement from baseline on IGA-FWS for
    patients treated with RT002:
    • SAKURA 1: 24.1 weeks
    • SAKURA 2: 24.1 weeks
    • BELMONT: 23.6 weeks2

SAFETY

RT002 appeared to be generally safe and well-tolerated through the end
of study at Week 36. Adverse events were mild, localized and transient.
There were no treatment-related serious adverse events. The most common
adverse events for RT002 in both studies combined were headache (6.4
percent) and injection site pain (3.7 percent). The incidence of eyelid
ptosis and brow ptosis were 2.2 percent and 0.7 percent, respectively.

About SAKURA Phase 3 Clinical Program

The SAKURA clinical program includes SAKURA 1 and SAKURA 2 – two
randomized, double-blind, placebo-controlled pivotal trials that were
identical in design to evaluate the safety and efficacy of a single
administration of RT002 for the treatment of moderate-to-severe
glabellar lines in adults from 18 to 75 years of age. The SAKURA 1 and
SAKURA 2 trials enrolled a total of 609 patients at 30 sites in the U.S.
and Canada. In both trials, patients were randomized 2:1 to receive
either RT002 (40U) or placebo. Post-treatment, patients were followed
for at least 24 weeks and up to 36 weeks.

The primary efficacy endpoint was the composite of the proportion of
patients who achieved a score of 0 or 1 (none or mild) and at least
two-point improvement from baseline in glabellar line severity on both
the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and
Patient Facial Wrinkle Severity (PFWS) scales, at maximum contraction
(frown), at Week 4. Duration of the reduction of severity of glabellar
lines was assessed as secondary efficacy endpoints.

The program also includes an open-label trial designed to evaluate the
long-term safety of RT002 in glabellar lines following both single and
repeat treatment administration. The long-term safety trial enrolled
more than 2,500 patients at 66 sites in the U.S. and Canada and is
expected to be completed in the second half of 2018.

About Glabellar Lines

The glabella is the skin between the eyebrows and above the nose.
Glabellar lines, often called "frown lines," are 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 toward 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 inhibiting movement of the muscles that cause the
frown lines, giving the skin a smoother, more refreshed appearance.

Based on data from Global Industry Analysts, Inc., the global market for
aesthetic treatments with neuromodulators represented about $1.6 billion
in revenue in 2016, and according to the American Society for Aesthetic
Plastic Surgery, botulinum toxin treatment is the No.1 nonsurgical
cosmetic procedure in the U.S. Management estimates glabellar line
treatment represents nearly $1 billion of the global market.

About RT002

DaxibotulinumtoxinA for Injection (RT002) is an investigational product.
It is a novel, next-generation neuromodulator in development for the
treatment of aesthetic and therapeutic conditions, including glabellar
lines, cervical dystonia and plantar fasciitis. Created using Revance's
proprietary peptide technology, RT002 has the potential to become the
first neuromodulator with long-acting duration of six months. This
proprietary, stabilizing excipient peptide technology eliminates the
need for human- and animal-based components, which carry a potential
risk of transmitting pathogens.

Revance has three active clinical programs for RT002 injectable under
way. With the SAKURA 1 and SAKURA 2 Phase 3 pivotal trials to treat
glabellar lines now completed, Revance plans to complete the SAKURA 3
open-label, long-term safety study in the second half of 2018. For
cervical dystonia, the company was recently granted orphan drug
designation and plans to initiate a Phase 3 program in 2018. A Phase 2
trial for RT002 for the management of plantar fasciitis is fully
enrolled, and the company plans to share results by year end 2017.

Conference Call

Individuals interested in listening to the conference call today,
December 5, at 5:00am PT/8:00am ET, may do so by dialing (855) 453-3827
for domestic callers, or (484) 756-4301 for international callers and
reference conference ID: 9076999; or from the webcast link in the
investor relations section of the Company's website at: http://investors.revance.com/index.cfm.

A replay of the call will be available beginning today at 8:00am
PT/11:00am ET through 8:00am PT/11:00am ET on December 6, 2017. To
access the replay, dial (855) 859-2056 or (404) 537-3406 and reference
conference ID: 9076999. The webcast will be available in the investor
relations section on the Company's website for 30 days following the
completion of the call.

About Revance Therapeutics, Inc.

Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and underserved
therapeutic conditions, including muscle movement disorders and pain.
The company's lead drug candidate, DaxibotulinumtoxinA for Injection
(RT002), is currently in development for the treatment of glabellar
lines, cervical dystonia and plantar fasciitis, with the potential to be
the first long-acting neuromodulator. Revance has developed a
proprietary, stabilizing excipient peptide technology designed to create
novel, differentiated therapies. The company has a comprehensive
pipeline based upon its peptide technology, including 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 our business strategy, timeline and other goals
and market for our anticipated products, plans and prospects; statements
about our ability to obtain regulatory approval; 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; 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 November 3, 2017.
These forward-looking statements speak only as of the date hereof.
Revance disclaims any obligation to update these forward-looking
statements.

References:

1. Data on file
2. Carruthers, J., et al. Injectable
DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2,
Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison with
OnabotulinumtoxinA and Placebo. Dermatol. Surg. 2017; 43: 1321 – 1331

View Comments and Join the Discussion!