- 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 -
"Our vision is to be the leader in neuromodulators in any form," said
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
The following clinical programs for DaxibotulinumtoxinA for Injection
(RT002) remain on track:
Cervical dystonia: The
ASPENPhase 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., Canadaand 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.
- Cervical dystonia: The
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 billionin 2017 and is currently expected to grow to $7 billionby 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,
"Revance Therapeutics" and the Revance logo are registered trademarks of
BOTOX is a registered trademark of
Forward-Looking Statements; Market Data
This press release contains forward-looking statements, including
statements related to
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
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
Nadine Tosk, 504-453-8344
News Provided by Acquire Media