HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, June
3, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the
presentation of data from the HERITAGE study at the 2016 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June
3-7. The study confirmed the efficacy, safety and
immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab
co-developed by Biocon and Mylan, in comparison to branded
trastuzumab.
"As one of the first companies in the industry to successfully
complete a confirmatory efficacy and safety study comparing a
proposed biosimilar to a branded cancer drug, this is a significant
milestone for Mylan's biosimilar program," Mylan President
Rajiv Malik said. "There is an
urgent, unmet need for more affordable versions of biologic
products and through our collaboration with Biocon we are
well-positioned to be at the forefront to help deliver these
complex products to patients around the world. We're pleased that
ASCO has recognized the importance of biosimilars in advancing
cancer care and the significant role they will play in providing
patients greater access to affordable treatment."
Kiran Mazumdar Shaw, Chairperson
and Managing Director, Biocon, added: "The positive outcomes of the
global Phase 3 clinical study with our proposed biosimilar
trastuzumab for HER2-positive breast cancer patients are a
significant milestone in our joint biosimilars development program
with Mylan. The trial will enable regulatory filings of our product
in the developed markets. Biocon remains committed to develop
affordable biologics and these study results will help us in
enhancing access for cancer patients, caregivers and healthcare
systems across the globe."
Worldwide, nearly 2 million women are diagnosed with breast
cancer each year, making it the second most common cancer in the
world. HER2-positive metastatic 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 HER2-positive
metastatic breast cancer patients. It is also indicated for
adjuvant treatment of HER2 overexpressing breast cancer and
metastatic gastric cancer. It is a targeted therapy that interferes
with the HER2 protein and impedes cancer cell growth.
"The HERITAGE study successfully met the predefined endpoints of
response equivalency. We are proud of this international
collaboration which puts us one step closer to approval of this
proposed biosimilar. The response rates at 24 weeks were 69.6% with
MYL-1401O combined with taxane chemotherapy versus 64% with branded
trastuzumab combined with the same chemotherapy agent. The ratio of
overall response and difference in overall response fell within a
narrow, pre-defined equivalence margin suggesting equal efficacy of
both products. Safety was comparable between treatment groups. The
rates of serious adverse events were 38% with MYL-1401O and 36%
with branded trastuzumab, and there was no difference in cardiac
safety," commented lead study author Dr. Hope S. Rugo, professor of Medicine at the
University of California, San
Francisco.
Details of the sessions as on the ASCO website are as
follows:
- "Abstract 583: A pharmacokinetics (PK) bioequivalence
trial of proposed trastuzumab biosimilar Myl-1401O (A) vs
EU-Herceptin® (B) and US-Herceptin®
(C)"
- June 5, 8-11 a.m. CDT (Poster Session)
- Poster #71
- Presenter: Cornelius F. Waller,
MD, University of Freiburg Medical
Center
- Location: Hall A
- Link to abstract on the ASCO website:
http://meetinglibrary.asco.org/content/163653-176
- "Abstract LBA503: HERITAGE: A phase III safety and
efficacy trial of the proposed trastuzumab biosimilar Myl-1401O
versus Herceptin®"
- June 6, 2:15-2:27 p.m. CDT (Oral Abstract Session)
- Presenter: Hope S. Rugo, MD,
University of California, San
Francisco
- Location: Hall D1
- Link to abstract on the ASCO website:
http://meetinglibrary.asco.org/content/162159-176
The abstract for the HERITAGE study has also been selected for
the Best of ASCO® program this summer which will include
several meetings across the globe.
Full session details and abstracts for the 2016 Annual Meeting
can be found on the ASCO website at am.asco.org.
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 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 within the equivalence margin (0.81,
1.24).
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 the Mylan and Biocon Collaboration
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 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 nearly 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 Mylan being well-positioned though its
collaboration with Biocon to be at the forefront to help deliver
complex biosimilars to patients around the world, the significant
role biosimilars will play in providing patients greater access to
affordable treatment and regulatory filings. 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.; Biocon Ltd.