HERTFORDSHIRE, England,
PITTSBURGH and MUMBAI, India, March
27, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Lupin Limited (Lupin) today announced that the European
Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending the approval of
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 positive CHMP opinion is based on a biosimilarity assessment
which included preclinical and clinical studies demonstrating
bioequivalence to the reference product. In addition, a phase 3
clinical studyi in patients with moderate-to-severe
active rheumatoid arthritis confirmed equivalence of Nepexto to the
reference product in terms of efficacy, safety and
immunogenicity.
The CHMP positive opinion will now be considered by the European
Commission (EC). Once approved the EC will grant a centralized
marketing authorization for member countries of the EU. The
decision on the EC's approval is expected in May 2020.
Mylan President Rajiv Malik commented, "We are pleased with
the positive CHMP opinion for Nepexto, biosimilar etanercept. This
recommendation validates the strong scientific program supporting
this important treatment, which is one of 20 products in our broad
and diverse biosimilars portfolio, and our shared commitment with
Lupin to help increase access to more affordable biologic
treatments, such as etanercept, in Europe and many other regions around the
world."
Vinita Gupta, CEO, Lupin Limited
said, "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. We are extremely
pleased with the positive CHMP opinion on our application. This
milestone brings us one step closer to bringing an affordable
biosimilar to etanercept to the European market through our partner
Mylan. Once approved by the European Commission, Nepexto will be
our first biosimilar to receive regulatory approval in Europe. Building on this progress, we continue
to focus on advancing our biosimilar pipeline."
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
growing 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 more than 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 timing of regulatory
approvals; that the CHMP positive opinion will now be considered by
the EC; once approved the EC will grant a centralized marketing
authorization for member countries of the EU; and the decision on
the EC's approval is expected in May
2020. 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 impact of public health outbreaks 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 our
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.
i Yamanaka H et al., A Comparative Study to
Assess the Efficacy, Safety and Immunogenicity of YLB113 and the
Etanercept Reference Product for the Treatment of Patients with
Rheumatoid Arthritis Rheumatol Ther. 2020;7(1):149–163.
doi:10.1007/s40744-019-00186-3
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SOURCE Mylan N.V.
