Revance Announces First Patient Enrolled for DaxibotulinumtoxinA in Glabellar Lines & Cervical Dystonia in China by Fosun Pha...
April 27 2021 - 8:00AM
Business Wire
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced that Shanghai Fosun Pharmaceutical Industrial
Development Co., Ltd., (Fosun Pharma Industrial), a wholly-owned
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd,
(Fosun Pharma), a leading healthcare group in China, has initiated
Phase 3 trials of DaxibotulinumtoxinA for Injection in China, for
the treatment of glabellar lines and cervical dystonia. Both trials
enrolled and dosed their first patients in April. China is a
fast-growing market for neuromodulators, with an estimated
aesthetics and therapeutics opportunity of $318 million in 2021
that is projected to increase to $762 million by 2027 (15.7%
CAGR)1.
“The initiation of Phase 3 clinical trials for the treatment of
glabellar lines and cervical dystonia marks an important
advancement in our international expansion efforts and partnership
with Fosun Pharma,” said Mark J. Foley, President and Chief
Executive Officer at Revance. “Fosun Pharma is a leading
pharmaceutical and healthcare company in China and we look forward
to continuing our collaboration with them in order to bring our
next-generation product to the second largest neuromodulator market
in the world.”
Revance entered into a license agreement with Fosun Pharma
Industrial in 2018, whereby Fosun Pharma Industrial received
exclusive rights to develop and commercialize Revance’s proprietary
long-acting neuromodulator, DaxibotulinumtoxinA for Injection, in
mainland China, Hong Kong and Macau (the Territory). Under the
license agreement, Fosun Pharma Industrial is responsible for
conducting necessary clinical studies, marketing and sales in the
Territory, while Revance is responsible for manufacturing drug
substance and finished drug product for Fosun Pharma Industrial’s
clinical and commercial activities. Under the terms of the license
agreement, Revance has received payments of over $30 million and is
eligible to receive additional potential development and sales
milestone payments of approximately $230 million, as well as tiered
royalty payments in low-double-digit to high-teen percentages on
future annual net sales.
1BOTULINUM TOXIN Global Market Trajectory & Analytics, GIA,
September 2020
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on
innovative aesthetic and therapeutic offerings, including its
next-generation neuromodulator product, DaxibotulinumtoxinA for
Injection. DaxibotulinumtoxinA for Injection combines a proprietary
stabilizing peptide excipient with a highly purified botulinum
toxin that does not contain human or animal-based components.
Revance has successfully completed a Phase 3 program for
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. Revance has also partnered with Viatris (formerly Mylan
N.V.) to develop a biosimilar to BOTOX®, which would compete in the
existing short-acting neuromodulator marketplace. Revance is
dedicated to making a difference by transforming patient
experiences. For more information or to join our team visit us at
www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE
SA.
BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to Revance’s business
strategy, plans, prospects and other goals; the market for
neuromodulators; Revance’s commercialization plans; and its
partnership with Fosun Pharma Industrial, constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. You should not rely
upon forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, levels of activity, performance, events,
circumstances or achievements reflected in the forward-looking
statements will ever be achieved or occur.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from our expectations. These risks and uncertainties relate, but
are not limited to: general economic and political conditions; the
results, timing, costs, and completion of our research and
development activities and regulatory approvals, including the
continuing delay in the FDA’s approval of the biologics license
application for DaxibotulinumtoxinA for Injection for the treatment
of glabellar lines; the impact of the COVID-19 pandemic on
manufacturing operations, supply chain, end user demand for
DaxibotulinumtoxinA for Injection, commercialization efforts,
business operations, clinical trials and other aspects of our or
Fosun Pharma Industrial’s business; our ability to source or
manufacture supplies for DaxibotulinumtoxinA for Injection; the
uncertain clinical development process; the risk that clinical
trials may not have an effective design or generate positive
results; the applicability of clinical study results to actual
outcomes; our or Fosun Pharma Industrial’s ability to obtain
regulatory approval of DaxibotulinumtoxinA for Injection; the rate
and degree of economic benefit, commercial acceptance and the
market, size and growth potential of DaxibotulinumtoxinA for
Injection, if approved; our or Fosun Pharma Industrial’s ability to
successfully commercialize DaxibotulinumtoxinA for Injection, if
approved, and the timing and cost of commercialization activities;
the status of commercial collaborations; our ability to obtain
funding for our operations; our ability to continue obtaining and
maintaining intellectual property protection for
DaxibotulinumtoxinA for Injection; and our financial performance,
including future revenue, expenses and capital requirements.
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 our periodic
filings with the Securities and Exchange Commission (SEC),
including factors described in the section entitled "Risks Factors"
on our Form 10-K filed with the SEC on February 25, 2021. The
forward-looking statements in this press release speak only as of
the date hereof. We disclaim any obligation to update these
forward-looking statements.
Source: Revance Therapeutics, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210427005100/en/
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 jessica.serra@revance.com or Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620 laurence@gilmartinir.com Media
Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media: Y&R: Jenifer Slaw,
347-971-0906 jenifer.slaw@YR.com or Trade Media: Nadine Tosk,
504-453-8344 nadinepr@gmail.com
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