HERTFORDSHIRE, England and
PITTSBURGH, and NEWARK, Calif., Feb.
28, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Revance Therapeutics, Inc. (Nasdaq: RVNC) today announced a global
collaboration and license agreement for the development and
commercialization of a proposed biosimilar to BOTOX®
(onabotulinumtoxinA). BOTOX is the market-leading neuromodulator
approved for the treatment of multiple indications and usage in
the United States with additional
approvals globally. The addition of this product further
solidifies Mylan's long term commitment to the development and
commercialization of biosimilars and complex products
globally.
"This will be a significant opportunity for Mylan as we add
another difficult-to-manufacture product to our pipeline. We have
reviewed the work done to date by Revance and we are extremely
excited and confident about our ability to bring this important
product to market. Bringing an affordable biosimilar version of
BOTOX to commercialization will offer patients a safe alternative
to this popular and highly effective treatment," commented Mylan
President Rajiv Malik. "Mylan
is pleased to partner with Revance in the global collaboration, and
share our scientific, regulatory and manufacturing capabilities and
commercialization expertise. Our global platform enables
investing in worldwide R&D collaborations for hard to make
products that will benefit patients across the globe."
The companies plan to work together to gain regulatory approval
in the development of this important biosimilar product, and
commercialize this product in the U.S., Europe and applicable markets throughout the
rest of the world. The collaboration includes an upfront
payment of $25 million to Revance,
with contingent milestone payments upon achievement of additional
clinical, regulatory and sales targets, plus sales royalties in all
relevant markets.
"Global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily,
exceeding $7 billion by 2024*.
Strategically, this partnership with Mylan allows Revance to remain
focused on the development and launch of our own premium,
long-acting RT002 neuromodulator, while also benefitting
financially from potential future milestones and sales royalties on
a short-acting biosimilar to BOTOX," said Dan Browne, President and Chief Executive
Officer of Revance Therapeutics. "We believe Mylan is the ideal
partner to co-develop, seek regulatory approval and market a
biosimilar to BOTOX, due to its significant expertise in the field
and its global commercial infrastructure."
About Mylan N.V.
Mylan is a global pharmaceutical
company committed to setting new standards in healthcare. Working
together around the world to provide 7 billion people access to
high quality medicine, we innovate to satisfy unmet needs; make
reliability and service excellence a habit; do what's right, not
what's easy; and impact the future through passionate global
leadership. We offer a growing portfolio of more than 7,500
marketed products around the world, including antiretroviral
therapies on which more than 40% of people being treated for
HIV/AIDS globally depend. We market our products in more than 165
countries and territories. We are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
approximately 35,000-strong workforce is dedicated to creating
better health for a better world, one person at a time. Learn more
at Mylan.com. We routinely post information that may be important
to investors on our website at investor.Mylan.com.
Forward Looking Statement for Mylan N.V.
This press
release includes statements that constitute "forward-looking
statements", including with regard to: that Mylan will bring a
biosimilar of BOTOX to the market through a collaboration and
license agreement with Revance Therapeutics; that the addition of
this complex product further solidifies Mylan's long term
commitment to the development and commercialization of biosimilar
and complex products globally; that this will be a significant
opportunity for Mylan as we add another difficult-to-manufacture
product to our pipeline; that we have reviewed the work done to
date by Revance and we are extremely excited and confident about
our ability to bring this important product to market; that
bringing an affordable biosimilar version of BOTOX to
commercialization will offer patients a safe alternative to this
popular and highly-effective treatment; that Mylan is pleased to
partner with Revance in the global collaboration and share its
scientific, regulatory and manufacturing capabilities and
commercialization expertise; that our global platform enables
investing in worldwide R&D collaborations for hard to make
products that will benefit patients across the globe; and that the
companies plan to advance the regulatory approval in the
development of this important biosimilar product, and commercialize
this product in the U.S., Europe
and applicable markets throughout the rest of the world; that
global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily,
exceeding $7 billion by 2024. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because such
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: success of clinical trials and our or our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our or our partners' ability to bring
products to market; other risks inherent in product development;
the scope, timing, and outcome of any ongoing legal proceedings,
including government investigations, and the impact of any such
proceedings on our or our partners' businesses; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in
the United States and abroad; the
impact of competition; strategies by competitors or other third
parties to delay or prevent product introductions; the effect of
any changes in our or our partners' customer and supplier
relationships and customer purchasing patterns; any other changes
in third-party relationships; changes in the economic and financial
conditions of the businesses of Mylan or its partners;
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan's filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
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 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.
*Sales estimates based on GIA Jan
2018 Report: Botulinum Toxin – A Global Strategic Business
Report
Forward Looking Statement for Revance Therapeutics,
Inc.
This press release contains forward-looking
statements, including statements related to our business strategy,
timeline and other goals and market for our anticipated products,
plans and prospects; statements about our ability to obtain
regulatory approval; and statements about 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; 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 quarterly report on Form 10-Q filed November 3, 2017. These forward-looking
statements speak only as of the date hereof. Revance disclaims any
obligation to update these forward-looking statements.
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SOURCE Mylan N.V.; Revance Therapeutics, Inc.