Revance Investor Day Highlights New Neuroscience Indications in Development
April 19 2018 - 11:30AM
Business Wire
- Lead product for treatment of glabellar lines
on track to report SAKURA Phase 3 open-label safety results in
second half of 2018 -
- Initiating Phase 3 pivotal trial for cervical
dystonia in current quarter -
- Company to add RT002 clinical programs in
adult upper limb spasticity and chronic migraine -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing neuromodulators for use in treating aesthetic
and therapeutic conditions, is holding its first Investor Day in
New York City today. Executive management intends to provide
company updates on the science underlying its technology platform,
its long duration product candidate DaxibotulinumtoxinA for
Injection (RT002) and key elements of its Product Launch Velocity
Plan.
"Our vision is to be the leader in neuromodulators in any form,"
said Dan Browne, President and Chief Executive Officer at Revance.
"We believe we have the science, analytic capabilities, clinical
data, production capacity and commercial approach needed to enter
the market from a place of strength. Our clinical trials indicate
that RT002 is a differentiated neuromodulator, appears to be
generally safe and well-tolerated and has shown high response rates
and long duration of effect. Upon approval by the FDA, we first
plan to launch our long-acting product, RT002, in the aesthetics
market to treat frown lines, while pursuing additional therapeutic
clinical programs focused on neuroscience. Our Product Launch
Velocity Plan for RT002 will rely heavily on a personalized,
targeted approach to generate consumer demand for the first
next-generation neuromodulator in 30 years.”
Key Company Updates and Announcements
Research & Development:
- The company intends to provide an
overview on its highly purified daxibotulinumtoxinA and the
mechanism of action for drug product candidate DaxibotulinumtoxinA
for Injection (RT002):
- RT002’s proprietary peptide excipient
serves as a unique stabilizing agent. No human serum albumin (HSA)
or animal-sourced ingredients, which can potentially be a source of
disease transmission, are used in the production of RT002.
- Based on stability studies to date,
RT002 may not require refrigeration during storage or
shipping.
- Demonstrated dosing and duration of
response is not linear because 20 units of the leading
neuromodulator, onabotulinumtoxinA (BOTOX®), and 40 units of RT002
contain nearly the same amount of active 150 kDa neurotoxin (0.17
ng 150 kDa vs 0.18 ng 150 kDa, respectively).
- In vitro data supports the hypothesis
that RT002 has strong membrane binding at the site of injection,
which the company believes contributes to long duration of effect
and high response rates.
Clinical, Regulatory and Launch Milestones:
- Revance expects to complete and report
the SAKURA Phase 3 open-label safety study consisting of
approximately 2,500 enrolled patients in the second half of 2018
and is on track to file its Biologics Licensing Application (BLA)
for RT002 to treat glabellar (frown) lines in first half of 2019.
Product launch is expected in 2020, assuming FDA approval.
- The following clinical programs for
DaxibotulinumtoxinA for Injection (RT002) remain on track:
- Cervical dystonia: The ASPEN Phase 3
program with RT002 for the treatment of moderate to severe isolated
cervical dystonia is planned for initiation in the second quarter
of 2018. Program is expected to include a single pivotal trial of
approximately 300 patients and an open-label safety study to
include approximately 300 patients from the U.S., Canada and
Europe.
- Plantar fasciitis: The 16-week results
from the now completed Phase 2a trial in plantar fasciitis showed a
58% reduction in pain from baseline along with a strong placebo
response, based on the visual analog scale (VAS) for pain. A
follow-on Phase 2 trial for plantar fasciitis is planned for the
second half of 2018. Study is expected to be double-blinded,
placebo-controlled utilizing two doses of RT002.
- The company is announcing two new
clinical programs for RT002 in neuroscience indications with plans
to initiate:
- Upper limb spasticity: A Phase 2 dosing
study in adult upper limb spasticity in the fourth quarter of 2018
with a goal to reduce the number of annual treatments.
- Chronic migraine: A Phase 2 study in
2019 using a novel approach to treat chronic migraine to optimize
the number of injections and designed to achieve long duration of
effect.
Market and Commercialization:
- The neurotoxin market was estimated to
be $4 billion in 2017 and is currently expected to grow to $7
billion by 2024.*
- Recent published surveys on
neuromodulators indicates that duration is the #1 unmet need for
physicians and long-lasting effect is the #1 patient request.
- The company has established the Revance
Product Launch Velocity Plan – covering sales, marketing, digital
outreach and commercial operations – and is preparing for an
anticipated launch of RT002 for the treatment of glabellar lines in
2020.
Webcast and Replay
Interested parties can view the slide presentation and access
the webcast for the Investor Day within the Investor Relations
section of the company's website at
http://investors.revance.com/index.cfm. The webcast replay will be
available today, April 19, after 7:00 pm ET and will remain on the
website for approximately 30 days.
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
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 www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.BOTOX is a registered
trademark of Allergan, Inc. * Source: Global Industry Analysts,
Inc. Botulinum Toxin – A Global Strategic Business Report, Jan
2018
Forward-Looking Statements; Market Data
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 annual report on Form 10-K
filed March 2, 2018. These forward-looking statements speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
This press release also includes information about the global
neuromodulator market, including growth and trends, that is based
on various publicly available sources and on a number of
assumptions and limitations. Such market data has been obtained
from sources believed to be reliable, but Revance has not
independently verified such information and assumes no
responsibility for the accuracy of such information. In addition,
projections, assumptions and estimates of the future performance of
the global neuromodulator market are necessarily subject to a high
degree of uncertainty and risk due to a variety of factors,
including those described above and in the “Risk Factors” section
of our Form 10-K filed with SEC on March 2, 2018. The market data
in this press release speaks only as of the date hereof or the date
specified. Revance disclaims any obligation to update or correct
such market data.
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version on businesswire.com: https://www.businesswire.com/news/home/20180419005385/en/
INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorMEDIAGeneral
Media:TOGORUN:Mariann Caprino, 917-242-1087m.caprino@togorun.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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