Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V.
(NASDAQ:MYL) (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.
Momenta Investor Contact
Sarah Carmody Momenta
Pharmaceuticals
1-617-395-5189 IR@momentapharma.com
Momenta Media ContactKaren SharmaMacDougall
Biomedical
Communications1-781-235-3060Momenta@macbiocom.com
Mylan ContactJulie Knell
(Media)724.514.1968
Melissa Trombetta (Investors)724.514.1813
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