BENGALURU, India, HERTFORDSHIRE, England and PITTSBURGH, July 21,
2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that
the European Medicines Agency (EMA) has accepted for review,
Mylan's Marketing Authorization Application (MAA) for our proposed
biosimilar Pegfilgrastim, which is used to reduce the duration of
neutropenia and the incidence of febrile neutropenia in adult
patients treated with cytotoxic chemotherapy for malignancy (with
the exception of chronic myeloid leukaemia and myelodysplastic
syndromes).
Mylan and Biocon, who have co-developed the proposed
biosimilar, received EMA's acceptance of the submission for
review. In addition to analytical, functional and
pre-clinical data, the application includes clinical data from
pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and
confirmatory efficacy, safety and immunogenicity studies completed
earlier in 2016. The results from the studies are expected to be
presented at the prestigious European Society of Medical Oncology
(ESMO) Annual Congress to be held in Copenhagen in Oct.
2016.
Arun Chandavarkar, CEO and
Joint Managing Director, Biocon, said: "The regulatory
submission of biosimilar Pegfilgrastim with the EMA by our partner
Mylan marks another significant milestone in our journey to develop
affordable biologics for cancer patients. Once approved, this
product will enable enhanced access to a cost-effective alternative
for patients undergoing chemotherapy in the EU. We are committed to
bring a diversified portfolio of high-quality, life-enhancing
biosimilars to patients globally."
Mylan President Rajiv Malik
commented: "We continue to make great progress across our
biosimilars portfolio, which represents one of the industry's
largest and most diversified portfolios in development. This
milestone in our Pegfilgrastim program represents yet another
important step in bringing more affordable versions of these
critical products to market, with Europe representing an exciting opportunity
for Mylan in this area."
Pegfilgrastim is prescribed for cancer patients to help them
with some of the side-effects of their treatment. It reduces the
duration of neutropenia (low levels of neutrophils, a type of white
blood cell that fights infections) and the incidence of febrile
neutropenia (neutropenia with fever) that are a result of their
chemotherapy treatment.
Biocon and Mylan are exclusive partners on a broad portfolio of
biosimilars and generic insulin analogs. The proposed biosimilar
Pegfilgrastim is one of the six biologic products co-developed by
Mylan and Biocon for the global marketplace. Mylan has exclusive
commercialization rights for the proposed biosimilar Pegfilgrastim
in the U.S., Canada, Japan, Australia, New
Zealand and in the European Union and European Free Trade
Association countries. Biocon has co-exclusive commercialization
rights with Mylan for the product 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 1,400 generic and branded
pharmaceuticals, including antiretroviral therapies on which
approximately 50% of people being treated for HIV/AIDS in the
developing world depend. We market our products in approximately
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 35,000-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 autoimmune, diabetes, and cancer. 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.
Visit: www.biocon.com
Forward-Looking Statement: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to the proposed biosimilar, once
approved, enabling Biocon and Mylan to provide access to biosimilar
Pegfilgrastim as a more cost-effective alternative for patients
undergoing cancer treatment in EU; Biocon and Mylan's commitment to
bringing a diversified portfolio of biosimilars to a global patient
pool; Mylan's biosimilars portfolio; opportunities in Europe with respect to biosimilars; and the
expected presentation of trial results. 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
biosimilars; any regulatory, legal, or other impediments to Mylan's
or its partners' ability to bring biosimilar candidates to market;
Mylan's and its partners' ability to protect intellectual property
and preserve intellectual property rights, including with respect
to biosimilar candidates; 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.
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SOURCE Mylan N.V.