- First neurotoxin formulation to be developed
as a potential biosimilar product to BOTOX®, potentially
giving Mylan access to 14 indications upon approval -
- $30 million milestone payable to Revance from
Mylan -
Revance Therapeutics, Inc. (NASDAQ: RVNC) and Mylan N.V.
(NASDAQ: MYL) today announced Mylan’s decision to move forward with
a development plan, under a 351(k) pathway, for a proposed
biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the
market-leading neuromodulator.
Feedback obtained from the U.S. Food and Drug Administration
(FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in
February 2019 indicated that the 351(k) regulatory pathway for an
onabotulinumtoxinA product is viable. Based on this meeting, along
with the results from additional characterization and analysis
completed by Revance, the two companies are now moving forward with
the development program.
“We are excited to move forward with Revance on a clear and
achievable development pathway for what will potentially be the
first biosimilar to BOTOX®, and to leverage our worldwide reach and
commercial expertise to maximize this exciting opportunity globally
while expanding access to this important product for patients,”
said Mylan President Rajiv Malik. “This collaboration adds another
high-profile, large-market, complex biologic, across both aesthetic
and therapeutic categories, to our industry-leading biosimilars
pipeline.”
Added Mark Foley, President and Chief Executive Officer of
Revance Therapeutics, “We are pleased with Mylan’s decision to
opt-in to the biosimilar to BOTOX development program, as it
reflects our mutual confidence in the path forward. Assuming
regulatory approval, it would allow us to financially participate
in the short-acting neuromodulator market, while focusing our
commercial efforts on creating the new, long-acting neuromodulator
category.”
Mylan and Revance signed a collaboration and license agreement
in February 2018 for the development and regulatory approval of a
biosimilar to BOTOX®, to be followed with commercialization by
Mylan in the U.S., Europe and applicable markets throughout the
rest of the world. The agreement included an upfront payment of $25
million to Revance. In August 2019, the companies amended the
agreement to include an additional one-time payment of $5 million
to extend the period in which Mylan could choose to continue its
collaboration and license agreement to develop Revance’s biosimilar
to BOTOX®.
With Mylan’s decision to move forward with the development
program announced today, a payment of $30 million is now payable to
Revance by Mylan. Furthermore, the collaboration and license
agreement also provides for an additional $70 million in milestone
payments, contingent upon the achievement of further clinical and
regulatory milestones. Additionally, per the agreement, Revance is
eligible to receive sales target milestone payments and royalties
in all relevant markets.
About Mylan
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
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: Mylan
This press release includes statements that constitute
"forward-looking statements," including with regard to the timing
of regulatory approvals and commercialization of products; the
outcome of clinical trials; the first neurotoxin formulation to be
developed as a potential biosimilar product to BOTOX®
potentially giving Mylan access to 14 indications upon approval; a
decision to move forward with a development plan, under a 351(k)
pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic
(onabotulinumtoxinA); that Mylan is excited to move forward with
Revance on a clear and achievable development pathway, for what
will potentially be the first biosimilar to BOTOX®, and to leverage
our worldwide reach and commercial expertise to maximize this
exciting opportunity globally while expanding access to this
important product for patients; and potential future milestone and
royalty payments. Because forward-looking statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such statements.
Factors that could cause or contribute to such differences include,
but are not limited to the potential widespread and highly
uncertain impact of public health outbreaks, epidemics and
pandemics, such as the COVID-19 pandemic; any changes in,
interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; the
effect of any changes in Mylan's or its partners' customer and
supplier relationships and customer purchasing patterns; other
changes in third-party relationships; the impact of competition;
changes in the economic and financial conditions of the businesses
of Mylan or its partners; the scope, timing, and outcome of any
ongoing legal proceedings and the impact of any such proceedings on
Mylan's or its partners' business; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States and abroad; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; risks associated with international
operations; other 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, 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 in 2020. 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 three therapeutic indications - cervical dystonia, adult
upper limb spasticity and plantar fasciitis. Beyond
DaxibotulinumtoxinA for Injection, Revance gained exclusive rights
to commercialize TEOXANE SA’s Resilient Hyaluronic Acid® (RHA®)
line of fillers in the U.S., the first and only range of
FDA-approved dermal fillers for correction of dynamic facial
wrinkles and folds. Revance has also begun development of 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 Statement: Revance Therapeutics
This press release contains forward-looking statements,
including statements related to Revance Therapeutics' 2020
financial outlook, expected cash runway 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, the initiation, design,
timing and results of our clinical studies, including the SAKURA 3
study of DaxibotulinumtoxinA for Injection, Phase 3 program for
treatment of cervical dystonia, Phase 2 and other clinical programs
for the management of plantar fasciitis and for the treatment of
adult upper limb spasticity, and related results and reporting of
such results; development of a biosimilar to BOTOX®; results of our
non-clinical programs; statements about our business strategy,
timeline and other goals and market for our anticipated products,
plans and prospects; including our pre-commercialization plans and
timing of our potential submission of a BLA filing for
DaxibotulinumtoxinA for Injection to treat glabellar (frown) lines
and potential regulatory approach and product launch; statements
about our ability to obtain, and the timing relating to, regulatory
approval with respect to our drug product candidates; statements
regarding additional milestone payments through our partnerships,
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
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 quarterly report on Form
10-Q filed May 8, 2020. 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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version on businesswire.com: https://www.businesswire.com/news/home/20200601005447/en/
Revance Contacts
INVESTORS Revance Therapeutics, Inc.: Jeanie Herbert,
714-325-3584 jherbert@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
Mylan Contacts
INVESTOR RELATIONS Melissa Trombetta 724-514-1814
MEDIA Mylan, Christine Waller 724-514-1968
Mylan NV (NASDAQ:MYL)
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