Market Overview

Revance Announces Publication of Positive 24-Week Duration of Effect Results from Cervical Dystonia Phase 2 Trial in Movement Disorders Clinical Practice


- RT002 achieved high response rate, long-lasting effect across all
treatment groups and doses -

- RT002 appeared generally safe and well-tolerated through Week 36 -

Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing neuromodulators for use in treating aesthetic and therapeutic
conditions, today announced that results of a Phase 2 study of
DaxibotulinumtoxinA for Injection (RT002) to treat moderate-to-severe
cervical dystonia (CD) have been published in the peer-reviewed journal Movement
Disorders Clinical Practice

These positive 24-week results from a Phase 2 open-label,
dose-escalating study were announced in May 2017 and were formally
presented at the 21st International Congress of Parkinson's
Disease and Movement Disorders in June 2017. The previously reported
findings demonstrate that RT002 injectable provided clinically
significant improvement in the signs and symptoms of CD as determined by
reduction of the Toronto Western Spasmodic Torticollis Rating Scale
(TWSTRS)-Total score from baseline. In addition, RT002 was found to be
generally safe and well-tolerated.


study included 21 patients (Group A) who received 100 to 240 units of
RT002 injectable and 16 (Group B) who received 300 to 450 units. Median
duration of effect, defined as the number of weeks study participants
maintained at least 20 percent of the treatment benefit achieved at Week
4 (Target TWSTRS Score), was greater than 24 weeks for both dose groups
(25.3 weeks). This is consistent with the ≥ 24-week duration of effect
previously reported in each of the trial's three pre-specified patient

clinically significant mean reduction in the TWSTRS-Total score from
baseline at Week 4 - the primary efficacy endpoint - in both Group A (37
percent) and Group B (39 percent), with the majority of this benefit
maintained through Week 24. In addition, clinically meaningful
reductions in TWSTRS-Severity, Disability and Pain subscales were
consistent and observed at all time points through Week 24.

of response was observed in the study, with 94 percent of patients
experiencing a reduction of at least 20 percent from baseline in
TWSTRS-Total Score at Week 6, and 68 percent maintained this treatment
benefit at Week 24. In addition, a mean reduction of 37 percent from
baseline in the Cervical Dystonia Impact Profile (CDIP-58) score was
observed at Week 6 for all patients, with the majority of this
clinically meaningful benefit maintained through Week 24.

SAFETY FINDINGS: As previously reported, RT002
injectable appeared to be generally safe and well-tolerated through Week
24 in all treatment groups. There were no serious adverse events and no
dose-dependent increase in adverse events. The most common
treatment-related adverse events were dysphagia (14 percent) and
injection site erythema (8 percent), and these were generally
characterized as mild to moderate and were transient, with one case of
neck pain reported as severe (Day 10 onset; duration two days).

"Cervical dystonia is a movement disorder characterized by involuntary
movements of the head and neck resulting in abnormal twisting postures
of the head that is frequently associated with pain. The treatment of
choice for cervical dystonia is botulinum toxin injections.
Unfortunately, the drawback of this therapy, as currently available, is
that patients must typically be re-treated at approximately three to
four month intervals in order to maintain benefit," said trial
investigator Joseph Jankovic, MD, Professor of Neurology and
Distinguished Chair in Movement Disorders, Baylor College of Medicine.
"The data from the now published RT002 study indicated that this new
formulation of botulinum toxin serotype A may significantly improve
symptoms of cervical dystonia and have an impressive duration of benefit
of 24 weeks, which is almost twice as long as the toxins currently
available. The Phase 3 ASPEN cervical dystonia program will ultimately
determine if the results of this Phase 2 study published in Movement
Disorders Clinical Practice
are replicated."

In November 2017, the U.S. Food and Drug Administration granted RT002
orphan drug designation for the treatment of cervical dystonia. The
FDA grants this designation to drugs intended to treat rare conditions
that affect fewer than 200,000 people in the United States.

"The emergence of a new, differentiated neuromodulator is a potentially
significant advance for physicians and their patients," said Revance
President and Chief Executive Officer Dan Browne. "Acceptance in a
peer-reviewed publication further validates the significance of our
cervical dystonia clinical program and underscores the confidence we
have in the long duration of effect of RT002 for treating a condition
that takes such a toll on patient quality of life. We look forward to
additional data from the upcoming ASPEN Phase 3 trials to further
characterize the safety, efficacy and duration of effect of RT002 in
this important orphan disease indication."

CD Phase 2 Study Design

Revance's Phase 2 trial was an open-label, sequential, dose-escalating
study designed to evaluate the safety, preliminary efficacy and duration
of effect of a single treatment of DaxibotulinumtoxinA Injectable
(RT002) for isolated cervical dystonia. Thirty-seven patients with
moderate-to-severe cervical dystonia were enrolled at multiple sites in
the United States. The trial's first cohort of 12 patients received a
single dose of up to 200 units of RT002 injectable, the second cohort of
12 patients received between 200 and 300 units, and the third cohort of
13 patients received from 300 to 450 units.

The primary efficacy endpoint of the Phase 2 study was an improvement in
dystonia symptoms as measured by change (reduction) from baseline in
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score
at four weeks. TWSTRS is a validated composite scale that evaluates the
severity of the condition based on the physical findings of dystonia as
well as the patient's perceived level of disability and pain associated
with the condition. The study protocol also featured a number of
secondary efficacy endpoints.

Patients were followed for up to 24 weeks after treatment, or until
return of symptoms that warrant treatment, at which time they could
complete the study. Due to the long duration of effect seen in the first
group, patients in the second and third groups were given the option to
continue. Several patients elected to remain in the study and were
followed for up to 36 weeks.

ASPEN Phase 3 CD Clinical Program

The ASPEN Phase 3 program with RT002 for the treatment of
moderate-to-severe isolated cervical dystonia is planned to start in the
second quarter this year. The program is expected to include a single
pivotal trial, plus an open-label trial, totaling approximately 300
patients from the U.S., Canada and Europe.

Additional information about the ASPEN Phase 3 program, including
patient eligibility criteria, will be available at

About Cervical Dystonia

According to the Dystonia Medical Research Foundation, cervical dystonia
is a painful condition in which the neck muscles contract involuntarily,
causing abnormal movements and awkward posture of the head and neck. The
movements may be sustained (tonic), jerky (clonic), or a combination.
Cervical dystonia (also referred to as spasmodic torticollis) may be
primary (meaning that it is the only apparent neurological disorder,
with or without a family history) or may be the result of secondary
causes (such as physical trauma), and can cause considerable pain and

Treatments for cervical dystonia include oral medications, botulinum
toxin injections, surgery, and complementary therapies. Botulinum toxin
blocks the communication between the nerve and the muscle, relaxing the
muscle, which alleviates abnormal involuntary movements and postures.
Current botulinum toxin treatments for cervical dystonia have a duration
of effect of approximately three months. Cervical dystonia can occur at
any age, although most individuals first experience symptoms in middle
age. The condition affects a few hundred thousand adults and children in
the United States alone. Revance estimates the global market for
treating muscle movement disorders with botulinum toxins, including
cervical dystonia, was nearly $1.1 billion in 2017.

About Revance Therapeutics, Inc.

Revance Therapeutics is a biotechnology company developing
neuromodulators for use in treating aesthetic and 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 plans to initiate studies in upper
limb spasticity and chronic migraine. RT002 has 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

"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' long-term financial outlook
and other financial performance, the process and timing of, and ability
to complete, current and anticipated future clinical development of our
investigational drug product candidates, including but not limited to
initiation and design of clinical studies for current and future
indications, related results and reporting of such results; statements
about our business strategy, timeline and other goals and market for our
anticipated products, plans and prospects; and statements about our
ability to obtain regulatory approval; and 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 May 9, 2018. These
forward-looking statements speak only as of the date hereof. Revance
disclaims any obligation to update these forward-looking statements.

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