HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Nov.
3, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
the European Medicines Agency (EMA) has accepted for review Mylan's
Marketing Authorization Application (MAA) for insulin glargine, a
long-acting insulin analog used to treat adults with type 2
diabetes and adults and pediatric patients (children 6 years and
older) with type 1 diabetes for the control of high blood
sugar.
Mylan and Biocon, which have co-developed insulin glargine, look
forward to offering another insulin treatment option for diabetic
patients, who are often facing significant expense to manage their
disease.
This filing includes analytical, functional and pre-clinical
data, as well as results from the pharmacokinetics (PK) and
confirmatory efficacy/safety global clinical trial in Type 2
diabetes patients comparing Mylan's and Biocon's Insulin glargine
with Lantus. The PK study demonstrated PK and PD bioequivalence of
Mylan's and Biocon's insulin glargine relative to that of the
reference drug Lantus.
Mylan President Rajiv Malik
commented: "The acceptance of our regulatory submission for
insulin glargine in Europe is yet
another example of the strong progress we continue to make across
the exciting portfolio of complex products we have in development,
and is another demonstration of the success of our partnership with
Biocon. Fifteen percent of the world's pharmaceutical spend will be
on diabetes medicines by 2020[1] and there is a significant unmet
need around the world for more affordable versions of injectable
insulin products. We look forward to helping serve this patient
population, building on our existing strength in oral diabetic
drugs, by bringing this product to the European market and other
markets around the world upon approval."
Dr Arun Chandavarkar, CEO
& Joint MD, Biocon, commented: "The acceptance of
the insulin glargine application for review by the EMA is another
important milestone in Biocon's collaboration with Mylan. This
is the third filing from our portfolio comprising biosimilar
monoclonal antibodies, insulin analogs and other recombinant
proteins to be accepted by EMA in 2016. Importantly, this is
the first filing in a developed market that incorporates product
validated at our state-of-the-art Malaysia facility and takes us a step closer
to our mission of improving access to more affordable insulins
globally."
About Biocon and Mylan Partnership
Biocon and Mylan
are exclusive partners on a broad portfolio of biosimilars and
insulin analogs. Glargine is one of the three insulin analogs being
co-developed by Mylan and Biocon for the global marketplace. Mylan
has exclusive commercialization rights for insulin glargine in the
U.S., Canada, Australia, New
Zealand, the European Union and European Free Trade
Association countries.
Biocon has exclusive rights for Japan and a few emerging markets; and
co-exclusive commercialization rights with Mylan in the rest of the
world.
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 2,700 generic
and branded pharmaceuticals, including antiretroviral therapies on
which approximately 50% of people being treated for HIV/AIDS
worldwide depend. We market our products in more than 165 countries
and territories. Our global R&D and manufacturing platform
includes more than 50 facilities, and we are one of the world's
largest producers of active pharmaceutical ingredients. Every
member of our more than 40,000-strong workforce is dedicated to
creating better health for a better world, one person at a time.
Learn more at mylan.com
About Biocon
Biocon Limited, publicly listed in
2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is
India's largest and
fully-integrated, innovation-led biopharmaceutical company. As an
emerging global biopharmaceutical enterprise serving customers in
over 100 countries, it is committed to reduce therapy costs of
chronic diseases like diabetes, cancer and autoimmune. Through
innovative products and research services it is enabling access to
affordable healthcare for patients, partners and healthcare systems
across the globe. It has successfully developed and taken a range
of Novel Biologics, Biosimilars, differentiated Small Molecules and
affordable Recombinant Human Insulin and Analogs from 'Lab to
Market'. Some of its key brands are INSUGEN® (rh-insulin), BASALOG®
(Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and
ALZUMAb™ (Itolizumab), a 'first in class' anti-CD6 monoclonal
antibody. It has a rich pipeline of Biosimilars and Novel Biologics
at various stages of development including Insulin Tregopil, a high
potential oral insulin analog.
Forward-Looking Statement: Mylan
This press release
includes statements that constitute "forward-looking statements,"
including with regard to regulatory filings; Mylan offering
another insulin treatment option for diabetic patients; Mylan's
portfolio of complex products in development; Mylan's partnership
with Biocon; future pharmaceutical spend; and plans to bring the
product to European and other markets. 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: any changes in or difficulties with Mylan's or its
partners' ability to develop, manufacture, and commercialize
products; any regulatory, legal, or other impediments to Mylan's or
its partners' ability to bring products to market; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; 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;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad;
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 Statement: Biocon
Certain
statements in this release concerning our future growth prospects
are forward-looking statements, which are subject to a number of
risks, uncertainties and assumptions that could cause actual
results to differ materially from those contemplated in such
forward-looking statements. Important factors that could cause
actual results to differ materially from our expectations include,
amongst others general economic and business conditions in
India, our ability to successfully
implement our strategy, our research and development efforts, our
growth and expansion plans and technological changes, changes in
the value of the Rupee and other currency changes, changes in the
Indian and international interest rates, change in laws and
regulations that apply to the Indian and global biotechnology and
pharmaceuticals industries, increasing competition in and the
conditions of the Indian biotechnology and pharmaceuticals
industries, changes in political conditions in India and changes in the foreign exchange
control regulations in India.
Neither our company, our directors, nor any of our affiliates, have
any obligation to update or otherwise revise any statements
reflecting circumstances arising after this date or to reflect the
occurrence of underlying events, even if the underlying assumptions
do not come to fruition.
[1] IMS Institute report, "Global Medicines Use in 2020,"
Nov. 2015
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SOURCE Mylan N.V.