- 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
- Company to add RT002 clinical programs in adult upper limb
spasticity and chronic migraine -
NEWARK, Calif.--(BUSINESS WIRE)--
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,
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
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
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
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
* 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180419005385/en/
Revance Therapeutics, Inc.:
Ami Bavishi, 212-213-0006
Mariann Caprino, 917-242-1087
Nadine Tosk, 504-453-8344
Source: Revance Therapeutics, Inc.
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