HERTFORDSHIRE, England
and PITTSBURGH and BENGALURU, India, Dec. 27,
2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
the results of the HERITAGE study have been published in the
Journal of the American Medical Association (JAMA). Study results
confirm the efficacy, safety and immunogenicity of MYL-1401O, the
proposed biosimilar trastuzumab co-developed by Mylan and Biocon,
in comparison to branded trastuzumab. The results of the trial were
first presented at this year's American Society of Clinical
Oncology (ASCO) Annual Meeting and the European Society for Medical
Oncology (ESMO) Congress. Branded trastuzumab is indicated to treat
certain HER2-positive breast and gastric cancers.
Dr. Hope S. Rugo, professor of
medicine at the University of California, San
Francisco, commented: "We are encouraged by the confirmatory
efficacy and safety results of the HERITAGE study recently
published in JAMA. This study was the last major step of a
multiple-phased program to demonstrate that proposed biosimilar
trastuzumab meets the criteria for equivalence in comparison to
branded trastuzumab. Published study results showed an overall
response rate of 69.6% for MYL-1401O compared to 64% for branded
trastuzumab. Tumor progression, progression-free survival and
overall survival was not statistically different between proposed
biosimilar trastuzumab and branded trastuzumab at week 48."
Mylan President Rajiv Malik
added: "We are proud that JAMA has recognized the results of the
HERITAGE study and are encouraged that the proposed biosimilar
trastuzumab, MYL-1401O, could provide an effective treatment option
for metastatic breast cancer patients. Phase 3 study results show
that a biosimilar can deliver similar efficacy in comparison to a
branded product. Once approved, we believe our proposed biosimilar
trastuzumab will provide a lower cost treatment option for breast
cancer patients. We look forward to continuing our industry-leading
role with Biocon to expand patient access across the globe to this
critically important medicine as well as Mylan's broad portfolio of
15 additional biologics and insulin analogs currently in
development."
Dr. Narendra Chirmule, Sr. Vice
President & Head R&D, Biocon, said: "The development of
biosimilars requires a systematic scientific approach from design
of the process to development. Biocon and Mylan have a
scientifically rigorous, ethically compliant and structured
development strategy to establish comparative safety and efficacy
of our products. The global clinical progress of our various
biosimilars programs demonstrates the strength of our R&D
capabilities in this area. We are pleased that JAMA has published
the clinical study results of trastuzumab after its very rigorous
peer review process."
The HERITAGE data was submitted by Mylan to the U.S. Food and
Drug Administration (FDA) as part of the biologics license
application (BLA) for MYL-1401O last month.
The full study, "Effect of a Proposed Trastuzumab Biosimilar
Compared With Trastuzumab on Overall Response Rate in Patients With
ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized
Clinical Trial," can be accessed on JAMA's website:
http://jamanetwork.com/journals/jama/fullarticle/2590051.
Dr. Rugo is an independent consultant for Mylan. She serves
as the Chair of the Steering Committee for the HERITAGE Study and
does not receive compensation from Mylan.
About the HERITAGE 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 safety and
progression free survival, overall survival at 48 weeks. 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 within the equivalence margin (0.81,
1.24).
About the Biocon and Mylan Partnership
Mylan
and Biocon are exclusive partners on a broad portfolio of
biosimilar and insulin products. 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 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 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 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 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 Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to proposed biosimilar
trastuzumab's potential to provide an effective treatment option
for metastatic breast cancer patients; approval and cost of
proposed biosimilar trastuzumab; Mylan's partnership with Biocon;
and expanding patient access across the globe to this medicine as
well as Mylan's broad portfolio of 15 additional biologics and
insulin analogs currently in development. 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;
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: 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.; Biocon Ltd.