BENGALURU, India
and HERTFORDSHIRE, England
and PITTSBURGH, Aug. 25, 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 a proposed biosimilar Trastuzumab, which is used to treat
certain HER2-positive breast and gastric cancers. This is the
second biosimilar submission developed by the partnership that has
been accepted for review in Europe. Last month, Mylan's MAA for the
proposed biosimilar Pegfilgrastim was accepted for review by
EMA.
Mylan and Biocon, which have co-developed this proposed
biosimilar, anticipate that this may be the first MAA for a
Trastuzumab biosimilar accepted by the EMA for review.
This filing includes analytical, functional and pre-clinical
data, as well as results from the pharmacokinetics (PK) and
confirmatory efficacy/safety global clinical trials for
Trastuzumab. The PK study had demonstrated measured bioequivalence
of Mylan's and Biocon's proposed Trastuzumab biosimilar relative to
that of the reference drug. The second study, the 'HERITAGE Study',
evaluated the efficacy, safety and immunogenicity of the proposed
biosimilar Trastuzumab in comparison to branded Trastuzumab.
Mylan President Rajiv Malik
commented: "The acceptance of our regulatory submission of
our proposed biosimilar Trastuzumab in Europe is another example of the strong
progress we continue to make across our broad biosimilars
portfolio. Following our successful commercialization in
India and emerging markets, we
look forward to our pending launch in Europe. Europe represents a key market for more
affordable versions of these important products, as governments
across the region strive to reduce healthcare costs. We look
forward to continuing to work to bring this product to patients
upon approval."
Arun Chandavarkar, CEO and
Joint Managing Director, Biocon, said: "The regulatory
submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling
affordable access to this critical biologic therapy for the
treatment of HER2-positive breast cancer. We remain
committed to bring a diversified portfolio of high-quality,
life-enhancing biosimilars to patients globally."
At the annual American Society of Clinical Oncology (ASCO) event
held in June this year, 24 week data for the 'HERITAGE' study was
presented. The results of the 48 week extension data of the
'HERITAGE' study are expected to be presented at the upcoming
European Society for Medical Oncology Congress (ESMO) in
October.
About Biocon and Mylan Partnership
Biocon and Mylan
are exclusive partners on a broad portfolio of biosimilars and
insulin analogs. The proposed biosimilar Trastuzumab 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 Trastuzumab in the U.S., Canada, Japan, Australia, New
Zealand, 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 HER2-Positive Breast Cancer and Trastuzumab
Worldwide, nearly 2 million women are diagnosed with breast cancer
each year, making it the second most common cancer in the world.
HER2-positive breast cancer is an aggressive form of breast cancer
that tests positive for the human epidermal growth factor receptor
2 (HER2), which promotes cancer cell growth. Approximately 20% to
30% of primary breast cancers are HER2-positive. Trastuzumab is
indicated for the treatment of certain HER2-positive early stage
and metastatic breast cancer as well as HER2-positive metastatic
gastric cancer.
About the Heritage Study
The Phase III study,
HERITAGE, is a double-blind, randomized clinical trial designed to
evaluate comparative efficacy and safety of the proposed
trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab.
Eligible patients had centrally confirmed, measurable HER2-positive
metastatic breast cancer without prior chemotherapy or trastuzumab
for metastatic disease. Patients were randomized to receive either
MYL-1401O or branded trastuzumab with docetaxel or paclitaxel for a
minimum of eight cycles. Trastuzumab was continued until
progression. The primary endpoint is overall response at week 24 by
blinded central evaluation using RECIST 1.1. Secondary endpoints
include progression free survival, overall survival, and safety. A
sample size of 456 patients was calculated to demonstrate
equivalence in overall response at week 24 for MYL-1401O versus
branded trastuzumab, defined as a 90% confidence interval for the
ratio of best overall response rate within the equivalence margin
(0.81, 1.24). This study successfully met the predefined
equivalence criteria. The response rates at 24 weeks were 69.6%
with MYL-1401O combined with taxane chemotherapy versus 64% with
branded trastuzumab combined with taxane chemotherapy. The
incidence of adverse events was similar in the patients who
received MYL-1401O and those who received reference
trastuzumab.
About Biosimilars
A biosimilar medicine is a
biological medicine that is developed to be similar to an existing
biological medicine and has demonstrated no clinically meaningful
differences in safety, purity, and potency compared to that of the
reference biologic. A biosimilar product and its reference biologic
product are expected to have the same safety and efficacy profile
and are generally used to treat the same conditions. Biosimilars
may offer a less-costly alternative to existing biological
medicinal products that have lost their exclusivity rights.
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 in the
developing world 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 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.
Forward-Looking Statement: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to the belief that Mylan may
have submitted the first MAA for a Trastuzumab biosimilar that has
been accepted by the EMA for review; the proposed biosimilar, once
approved, enabling Biocon and Mylan to provide access to a
Trastuzumab biosimilar 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 the results of the 48
week extension data of the 'HERITAGE' study.. 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.