HERTFORDSHIRE, England,
PITTSBURGH and MUMBAI, India, June 4,
2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Lupin Limited (Lupin) today announced that the European
Commission (EC) has granted marketing authorization for
Nepexto®, a biosimilar to Enbrel®
(etanercept), for all indications of the reference product
including rheumatoid arthritis, juvenile idiopathic arthritis,
psoriatic arthritis, axial spondyloarthritis (including ankylosing
spondylitis and non-radiographic axial spondyloarthritis), plaque
psoriasis and paediatric plaque psoriasis.
The regulatory approval follows the adoption of a positive
opinion by the Committee for Medicinal Products for Human Use
(CHMP), which was based on a biosimilarity assessment including
preclinical and clinical studies demonstrating bioequivalence to
Enbrel. In addition, a phase 3 clinical study in patients with
moderate-to-severe active rheumatoid arthritis confirmed
equivalence of Nepexto to Enbrel in terms of efficacy, safety and
immunogenicity.
The centralized marketing authorization applies to all member
countries of the European Union.
Mylan President Rajiv Malik commented, "The approval of
Nepexto, our biosimilar etanercept, is a positive step forward as
we work to broaden our biosimilars franchise offerings and do our
part to increase access to biologic treatments for patients in many
European countries. This milestone reflects a strong scientific
program behind Nepexto and commitment by our teams and our partner,
Lupin, to bring the product to market as soon as possible. We look
forward to launching Nepexto in the second half of this year."
Vinita Gupta, CEO, Lupin Limited
said, "We are truly delighted with this approval. Nepexto is our
first biosimilar to receive regulatory approval in Europe. With this important milestone, we
bring an affordable biosimilar to the European market through our
partner Mylan. Biosimilars like Nepexto will play a critical role
in expanding access to patients in Europe, providing an effective treatment for
multiple therapies including rheumatoid arthritis."
Enbrel had sales of approximately $9.6
billion globally for the 12 months ending December 2019, according to IQVIA.
In June 2018, Lupin and Mylan
announced a collaboration to commercialize a biosimilar to
etanercept in several global markets.
About Etanercept
Etanercept is an injectable, biologic
medicine which inhibits Tumour Necrosis Factor (TNF). TNF is a key
cytokine involved in the pro-inflammatory cascade in many chronic,
immune-mediated inflammatory diseases such as rheumatoid arthritis,
psoriatic arthritis, axial spondyloarthritis or plaque psoriasis.
By specifically binding to TNF, etanercept blocks its activity,
thereby reducing inflammation and other disease symptoms.
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 approximately 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.
About Lupin Limited
Lupin is an innovation-led
transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and
commercializes a wide range of branded and generic formulations,
biotechnology products and APIs in over 100 markets in the U.S.,
India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys leadership position in the cardiovascular,
anti-diabetic, and respiratory segments and has significant
presence in the anti-infective, gastro-intestinal (GI), central
nervous system (CNS) and women's health areas. Lupin is the third
largest pharmaceutical company in the U.S. by prescriptions and in
India by global revenues. The
Company invests 9.6 % of its revenues on research and
development.
Lupin has fifteen manufacturing sites, seven research centers,
more than 20,000 professionals working globally, and has been
consistently recognized as a 'Great Place to Work' in the
Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
Follow us on Twitter: https://twitter.com/LupinGlobal
LinkedIn: https://www.linkedin.com/company/lupin/
Facebook: http://www.facebook.com/LupinWorld/
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to the approval of Nepexto, a
biosimilar etanercept, being a positive step forward as we work to
broaden our biosimilars franchise offerings and do our part to
increase access to biologic treatments for patients in many
European countries; this milestone reflecting a strong scientific
program behind Nepexto and commitment by our teams and our partner,
Lupin, to bring the product to market as soon as possible; and
looking forward to launching Nepexto in the second half of this
year. 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[1] 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.
Forward-Looking Statements: Lupin
This press
release includes statements that constitute "forward-looking
statements", including with regard to: Mylan and Lupin's
commercialization of a biosimilar to Enbrel® (etanercept); that the
introduction of biosimilars is an important mechanism to help
increase access to more affordable biologics treatments, and
Mylan's industry-leading portfolio of 20 biosimilar products
positions Mylan to be at the forefront of delivering those savings;
that Mylan looks forward to working closely with Lupin to bring
their etanercept biosimilar to market and reach patients in
Europe, Australia, Latin
America and Asia. 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.
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SOURCE Mylan N.V.