HERTFORDSHIRE, England
and PITTSBURGH and BENGALURU, India, May 15,
2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
final data from the HERITAGE study will be presented at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago. The HERITAGE study
compared Ogivri™ to the reference product,
Herceptin®, in patients with HER2+ metastatic breast
cancer in combination with taxanes for the first 24 weeks and then
as a monotherapy until progression. Safety and overall survival,
cumulative through 36 months of follow-up, will be presented as
part of the Breast Cancer - Metastatic session, "HER2-Positive
Disease: How Far Have We Come?," on June
2.
Mylan Head of Global Biologics,
R&D, Arnd Annweiler, commented:
"We're pleased with the final results of the landmark HERITAGE
study which further validate the safety and efficacy profile of
Ogivri and confirm that no clinically meaningful differences exist
between the biosimilar product and Herceptin in terms of safety,
purity and potency. We have long been committed to the science and
clinical data behind this important treatment and are proud to
reach this milestone. Today, we continue on our mission to increase
access to Ogivri and the additional biosimilars in our pipeline for
patients around the world. We're grateful for ASCO's recognition of
this critical study over the past years and the important role they
have played in educating and instilling confidence in healthcare
providers and patients about the safety, efficacy and value of
biosimilars."
Christiane Hamacher, CEO, Biocon
Biologics, said: "The final safety and overall survival data from
the HERITAGE study for our biosimilar trastuzumab, Ogivri,
cumulative through 36 months of follow up, reconfirms that efficacy
and safety is very similar to the reference product, Herceptin. The
presentation of this data at ASCO will enable a wider adoption of
our biosimilar trastuzumab which has so far benefited thousands of
patients across the globe. Biocon Biologics is committed to enable
access to this high quality affordable therapy for HER2-positive
breast and gastric cancer patients as we strive to co-create a
healthy future."
Following are the session details:
- Abstract 1021: Biosimilar trastuzumab-dkst monotherapy
versus trastuzumab monotherapy after combination therapy: Final
overall survival (OS) from the phase III HERITAGE
Trial
-
- Date: June 2, 2019
- Poster display: #102, 8-11 a.m.
CDT, Hall A
- Poster discussion: 11:15 a.m.-12:45 p.m.
CDT, Hall D2
- Session: Breast Cancer – Metastatic
- Presenter: Dr. Cornelius Waller,
Department of Haematology, Oncology and Stem Cell Transplantation,
University Medical Centre Freiburg and Faculty of Medicine,
University of Freiburg, Freiburg,
Germany
Mylan and Biocon's biosimilar for Herceptin has received
regulatory approval in more than 65 countries
worldwide.
About the HERITAGE Study
HERITAGE is a double-blind,
randomized clinical trial designed to evaluate comparative efficacy
and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly
known as 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
trastuzumab-dkst 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 trastuzumab-dkst
versus branded trastuzumab, defined as a 90% confidence interval
for the ratio of best overall response within the equivalence
margin (0.81, 1.24).The primary endpoint has previously been
reported: the overall response rate in patients with HER2-positive
metastatic breast cancer at week 24 was equivalent between the
trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA.
2017;317:37-47).
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 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. 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. We routinely post information that may be
important to investors on our website at investor.mylan.com.
About Biocon
Biocon Limited, publicly listed in 2004,
(BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is a
fully-integrated, innovation-led global biopharmaceutical company
committed to enhance affordable access to complex therapies for
chronic conditions like diabetes, cancer and autoimmune. The
Company has developed and commercialized a range of Biosimilars
(Monoclonal Antibodies, Pegfilgrastim, rh- Insulin and Insulin
Glargine), Novel Biologics and differentiated Small Molecules
and Generic Formulations in India
and Key emerging markets. It has a large portfolio of biosimilars
under global clinical development with three of these
commercialized in the developed markets of EU, U.S. and
Japan. It has promising novel
assets in immunotherapy under development. Some of its key brands
are INSUGEN® (rh-insulin), Basalog (insulin glargine), Basalog One®
(prefilled Glargine pen), CANMAb™ (Trastuzumab), KRABEVA®
(Bevacizumab), BIOMAb-EGFR® (Nimotuzumab)
www.biocon.com Follow-us on Twitter: @bioconlimited
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to the outcome of clinical
trials. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Because forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such statements. Factors that
could cause or contribute to such differences include, but are not
limited to any changes in, interruptions to, or difficulties with
Mylan's or its partners' ability to develop, manufacture, and
commercialize products; 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; any
regulatory, legal, or other impediments to Mylan's or its partners'
ability to bring products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; 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
This press
release may include statements of future expectations and other
forward-looking statements based on management's current
expectations and beliefs concerning future developments and their
potential effects upon Biocon and its subsidiaries/ associates.
These forward-looking statements involve known or unknown risks and
uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such
statements. Important factors that could cause actual results to
differ materially from our expectations include, amongst other:
general economic and business conditions in India and overseas, 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 and global
biotechnology and pharmaceuticals industries, changes in political
conditions in India and changes in
the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or
any of our subsidiaries/associates assume any obligation to update
any particular forward-looking statement contained in this
release.
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SOURCE Mylan N.V.