Accueil / Communiqués / Revance Announces China Market License Agreement with Fosun Pharma for RT002

Revance Announces China Market License Agreement with Fosun Pharma for RT002

Tuesday, December 4th 2018 at 1:06pm UTC

– Upfront payment of $30 million, plus potential milestone payment and
tiered royalties on future sales –

NEWARK, Calif.–(BUSINESS WIRE)– Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing next-generation neuromodulators for use in treating aesthetic
and therapeutic conditions, today announced that the company has entered
into a license agreement with Shanghai Fosun Pharmaceutical Industrial
Development Co., Ltd., (Fosun Pharma Industrial), a wholly-owned
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Fosun
Pharma), providing Fosun Pharma Industrial with the exclusive rights to
develop and commercialize Revance’s proprietary DaxibotulinumtoxinA for
Injection (RT002) in mainland China, Hong Kong and Macau (the
Territory). RT002 is a novel, long-lasting neuromodulator in development
for the treatment of aesthetic conditions, including glabellar and upper
facial lines, and neuroscience conditions including cervical dystonia,
plantar fasciitis, adult upper limb spasticity and chronic migraine.

Under the terms of the agreement, Revance will receive an upfront
payment of $30 million within 30 business days of entering into the
license agreement and is eligible to receive additional potential
development and sales milestone payments of up to $230.5 million, as
well as tiered low-double-digit to high-teen royalty payments on future
net sales. Fosun Pharma Industrial will be responsible for conducting
necessary clinical studies, marketing and sales in the Territory, while
Revance will be responsible for manufacturing drug substance and
finished drug product for both the clinical and commercial activities in
the Territory. There will be no transfer of intellectual property.

« Fosun Pharma is one of the leading healthcare companies in China, with
the expertise and access to reach both the aesthetics and therapeutic
markets. We see Fosun Pharma as an ideal partner to commercialize RT002
in the fast-growing Chinese market for neuromodulators,  » said Dan
Browne, president and chief executive officer at Revance. Fosun Pharma
already has a growing portfolio of products in facial aesthetics where
we plan to gain the first approval for RT002, backed by assets in a
broad range of important therapeutics indications. We look forward to
working with the Fosun Pharma team on the clinical, regulatory and
commercial pathways to introduce RT002 in this important, developing
geography. »

« We are pleased to partner with Revance to bring a truly next generation
neuromodulator to China, » said Yifang Wu, president and chief executive
officer of Fosun Pharma, the parent company of Fosun Pharma Industrial.
« At Fosun Pharma, our values are based on the care for life, innovation,
excellence and sustained partnership. Revance shares those values. The
safety profile, high response rates and long duration of effect provides
consumers and patients with an improved experience and gives us the
confidence that RT002 will be a highly effective neuromodulator
treatment. »

About RT002

DaxibotulinumtoxinA for Injection (RT002) is an investigational product
and the first neuromodulator with long-acting duration. It is a novel,
next-generation neuromodulator in development for the treatment of
aesthetic indications and a number of potential therapeutic conditions,
including movement disorders, pain and other neuroscience-based targets.
RT002 is the only neuromodulator using a Revance proprietary stabilizing
excipient peptide technology in its formulation, which results in high
efficacy, long duration and provides two-year product stability
requiring no refrigeration. RT002 is the first and only botulinum toxin
product sourced, processed and manufactured in the US and formulated
without human blood-derived products or manufactured using
animal-derived proteins.

Revance has four active clinical programs for RT002 injectable under
way. The SAKURA 1, SAKURA 2 and SAKURA 3 trials to treat glabellar lines
are complete. For cervical dystonia, the company was granted orphan drug
designation from the FDA and initiated a Phase 3 program in mid-2018.
The company plans to announce first patient dosing for Phase 2 trials
for RT002 for the management of plantar fasciitis and for adult upper
limb spasticity before year-end 2018.

About Shanghai Fosun Pharmaceutical (Group) Co., Ltd.

Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
(stock code: 600196.SH, 02196.HK) is a leading healthcare group in the
People’s Republic of China. Adhering to the mission of improving human
health, Fosun Pharma’s business covers all key sectors of healthcare
industry chain, including pharmaceutical manufacturing and R&D,
healthcare services, medical devices and medical diagnosis, as well as
pharmaceutical distribution and retail. Fosun Pharma always regards
innovation as the driving force for its business growth. The company
continuously optimized its pharmaceutical R&D system that integrates
biosimilars and innovative drugs and has established international R&D
teams in China, the United States, India, etc., forming a globally
interactive R&D system. Fosun Pharma maintains a national recognized
enterprise technology center and establishes innovative chemical drugs
platform, biologics platform, high-value generic drugs platform and
cell-therapy platform. At present, Fosun Pharma maintains the leading
position with its core products in various therapeutic areas, including
oncology, cardiovascular system, central nervous system, blood system,
metabolism and alimentary system and anti-infection. All products occupy
the leading position in each market segment.

About Revance Therapeutics, Inc.

Revance Therapeutics is an emerging Silicon Valley biotechnology leader
developing neuromodulators for the treatment of aesthetic and
therapeutic conditions. Revance uses a unique proprietary, stabilizing
excipient peptide technology to create novel, differentiated therapies.
The company’s lead compound, DaxibotulinumtoxinA for Injection (RT002),
is in clinical development for a broad range of aesthetic and
therapeutic indications, including glabellar lines, cervical dystonia,
plantar fasciitis, upper limb spasticity and chronic migraine. RT002 has
the potential to be the first long-acting neuromodulator. The company is
advancing a robust pipeline of 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 the anticipated receipt of payments and potential
receipt of development and sales milestones, as well as royalties on
potential future sales of RT002 under the license with Fosun Pharma; the
timing and conduct of regulatory, developmental and commercial
activities to be conducted under the license with Fosun Pharma; the
process and timing of, and ability to complete, current and anticipated
future clinical development of our investigational drug product
candidates, the initiation, design, timing and results of our clinical
studies, and related results and reporting of such results, including
the SAKURA 3 study of RT002; statements about our business strategy,
timeline and other goals and market for our anticipated products, plans
and prospects; including our pre-commercialization plans for RT002 to
treat glabellar (frown)
lines; and statements about our ability
to obtain regulatory approval with respect to our drug; and potential
benefits of our drug product candidates and our excipient peptide and
other 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 fact that we may not receive any milestone, royalty or other
payments from Fosun Pharma, our dependence on Fosun Pharma to timely and
successfully develop and commercialize RT002 in the China market, that
we may not obtain the anticipated financial and other benefits of the
license agreement with Fosun Pharma; 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;
unanticipated costs or delays in research, development, and
commercialization efforts; 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; 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 November 2, 2018. These forward-looking statements speak only as
of the date hereof. Revance disclaims any obligation to update these
forward-looking statements.


For Revance
Revance Therapeutics, Inc.:

Burns McClellan, Inc.:
Ami Bavishi

General Media:
Mariann Caprino

Trade Media:
Nadine Tosk

For Fosun Pharma
Anjiang Liu

Source: Revance Therapeutics, Inc.

Voir aussi

Study Demonstrates Cook Biotech’s OASIS® Wound Matrix Has Higher Rates of Healing in Pressure Ulcers Than Standard of Care

Wednesday, February 20th 2019 at 6:30pm UTC BLOOMINGTON, Ind.–(BUSINESS WIRE)– A recently published multi-center, randomized, …