CAMBRIDGE, Mass. and
HERTFORDSHIRE, England and PITTSBURGH, Jan. 3,
2018 /PRNewswire/ -- Momenta Pharmaceuticals, Inc.
(Nasdaq: MNTA) and Mylan N.V. (NASDAQ, TASE: MYL) today announced
the development strategy for M710, a proposed biosimilar to
EYLEA® (aflibercept) injection. EYLEA is the
market-leading vascular endothelial growth factor (VEGF) inhibitor
indicated for the treatment of neovascular (wet) age-related
macular degeneration, macular edema following retinal vein
occlusion, diabetic macular edema and diabetic retinopathy in
patients with diabetic macular edema. The companies plan to
initiate a pivotal clinical trial in patients in the first half of
2018.
This trial is a randomized, double-blind, active-control,
multi-center study in patients with diabetic macular edema to
compare the safety, efficacy and immunogenicity of M710 with
EYLEA.
"Expanding treatment access and providing high-quality,
affordable drugs for patients is a key attribute of our biosimilars
business and an important business objective at Momenta. We believe
our proposed biosimilar to EYLEA, in collaboration with Mylan, is
an attractive program with limited biosimilar competition, which
could result in a first to market advantage," said Craig Wheeler, President and Chief Executive
Officer of Momenta Pharmaceuticals.
Mylan President Rajiv Malik commented, "Advancing a biosimilar
to EYLEA to the clinical trial period in the first half of the year
is an exciting milestone in the development of this important
product. We are proud of the significant investments we've made in
building one of the industry's most robust biosimilar pipelines,
and we look forward to being at the forefront of offering patients
a more affordable version of this complex product."
About M710, a proposed biosimilar of EYLEA®
(aflibercept)
M710 is developed in collaboration by Mylan N.V. and Momenta
Pharmaceuticals. EYLEA is the market-leading vascular endothelial
growth factor (VEGF) inhibitor indicated for the treatment of
neovascular (wet) age-related macular degeneration, diabetic
macular edema, macular edema following retinal vein occlusion and
diabetic retinopathy in patients with DME. In 2016, global
net sales of EYLEA were $5.2
billion.
About Momenta
Momenta Pharmaceuticals is a
biotechnology company specializing in the detailed structural
analysis of complex drugs and is headquartered in Cambridge,
MA. Momenta is applying its technology to the development of
generic versions of complex drugs, biosimilar and potentially
interchangeable biologics, and to the discovery and development of
novel therapeutics for autoimmune indications.
To receive additional information about Momenta, please visit
the website at www.momentapharma.com, which does not form a
part of this press release.
Our logo, trademarks, and service marks are the property of
Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or
service marks are property of their respective owners.
Forward Looking Statement For Momenta Pharmaceuticals
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including
but not limited to the indications for which M710 may be approved
and marketed; the cost-effectiveness and quality of our
biosimilars, including M710; the market potential for M710; the
timing of approval or commercial launch of M710; the competitive
landscape of M710; and the timing of availability of clinical trial
results. Forward-looking statements may be identified by words such
as "believe," "could," "objective", "opportunity," ""plan,"
"strategy," "target" and other similar words or expressions, or the
negative of these words or similar words or expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors, including those referred to under
the section "Risk Factors" in the Company's Quarterly Report on
Form 10-Q for the quarter ended September 30, 2017 filed
with the Securities and Exchange Commission, as well as other
documents that may be filed by the Company from time to time with
the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company's actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. The Company is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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.
Forward Looking Statement for Mylan N.V.
This
press release includes statements that constitute "forward-looking
statements," including with regard to: targeting the initiation of
a pivotal clinical trial in patients in the first half of 2018;
the proposed biosimilar to EYLEA being an attractive program
with limited biosimilar competition, which could result in a first
to market advantage; advancing a biosimilar to EYLEA to the
clinical trial period in the first half of the year being an
exciting milestone in the development of this important product;
and looking forward to being at the forefront of offering patients
more affordable versions of these complex products. 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: success of clinical trials and our or our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our or our partners' ability to bring
products to market; other risks inherent in product development;
the scope, timing, and outcome of any ongoing legal proceedings,
including government investigations, and the impact of any such
proceedings on our or our partners' businesses; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in the
United States and abroad; the impact of competition;
strategies by competitors or other third parties to delay or
prevent product introductions; the effect of any changes in our or
our partners' customer and supplier relationships and customer
purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; 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.
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SOURCE Mylan N.V.