HERTFORDSHIRE, England and
PITTSBURGH, April 11, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced it
is partnering with Fujifilm Kyowa Kirin Biologics Co., Ltd. to
commercialize a biosimilar to Humira® (adalimumab)
developed by Fujifilm Kyowa Kirin Biologics. Through the
partnership agreement, Mylan will leverage its regulatory platform
to seek approval and commercialize the product in Europe.
Humira is a TNF-inhibitor1 aimed at treating multiple
chronic inflammatory conditions. The product is indicated in
Europe for the treatment of
rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic
arthritis, ankylosing spondylitis, Crohn's disease, ulcerative
colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Humira is the world's best-selling biologic medication and had
brand sales of approximately $4.1
billion in Europe for the
12 months ending Dec. 31, 2017,
according to IQVIA.
Mylan CEO Heather Bresch,
"Expanding access to biologics through the introduction of
biosimilars around the world is a key area of focus for Mylan. Our
partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab
biosimilar in Europe is an
exciting advancement for Mylan and for patients who are living with
chronic autoimmune conditions and need access to a high-quality,
more affordable treatment option."
President Rajiv Malik added, "We
believe Mylan's strong regulatory commercial platform in
Europe and scientific leadership
in the biosimilars space make us an ideal partner of choice. These
attributes combined with Fujifilm Kyowa Kirin Biologics' expertise
in biologics, position the two companies to bring an adalimumab
biosimilar to the European market in the near term."
The European Medicines Agency (EMA) accepted for review the
Marketing Authorisation Application for its proposed biosimilar to
Humira on May 18, 2017. The companies
expect to receive a decision from EMA in the second half of
2018.
Under the terms of the agreement between two companies, Fujifilm
Kyowa Kirin Biologics grants Mylan an exclusive license to
commercialize the adalimumab biosimilar in Europe and will receive an up-front fee. In
addition, Fujifilm Kyowa Kirin Biologics is eligible to receive a
subsequent commercialization milestone payment and sales royalties.
Mylan will be responsible for the sales activity of the product in
European countries. The two companies continue to negotiate for
commercializing the product in additional territories. In addition,
Mylan's partner Biocon will receive economic benefit through this
collaboration.
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 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.
1 TNF-α (tumor necrosis factor alpha) is a cytokine
that is involved in inhibition of tumorigenesis and defense against
infection. Overexpression of TNF-α is implicated in a range of
inflammatory diseases, including rheumatoid arthritis and
psoriasis.
Forward-Looking Statement
This press release
includes statements that constitute "forward-looking statements",
including with regard to: the commercialization of a
biosimilar to Humira® (adalimumab) developed by Fujifilm
Kyowa Kirin Biologics; that through the partnership agreement,
Mylan will leverage its regulatory platform to seek approval and
commercialize the product in Europe; that we believe Mylan's strong
regulatory commercial platform in Europe and scientific leadership in the
biosimilars space make us an ideal partner of choice; that these
attributes combined with Fujifilm Kyowa Kirin Biologics' scientific
expertise in biologics, position the two companies to bring an
adalimumab biosimilar to the European market in the near term; that
the companies expect to receive a decision from EMA in the second
half of 2018; and that the two companies continue to negotiate for
commercializing the product in additional territories. 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.