CAMBRIDGE, Mass. and
HERTFORDSHIRE, England and
PITTSBURGH, Nov. 2, 2016 /PRNewswire/ -- Momenta
Pharmaceuticals, Inc. (Nasdaq: MNTA) and Mylan N.V. (NASDAQ,
TASE: MYL), today announced that dosing has begun in a Phase 1
study to compare the pharmacokinetics, safety and immunogenicity of
M834, a proposed biosimilar of ORENCIA (abatacept), to US- and
EU-sourced ORENCIA in normal healthy volunteers. Under the
Momenta-Mylan collaboration agreement, Momenta has achieved the
milestone necessary to earn a $25
million payment from Mylan.
"We are deeply committed to expanding treatment access and
providing high-quality and affordable biosimilar options for
patients who suffer from autoimmune and inflammatory diseases,"
said Craig Wheeler, President and
Chief Executive Officer of Momenta Pharmaceuticals. "Our
collaboration with Mylan, one of the largest generics and specialty
pharmaceutical companies in the world, positions us to advance this
important biosimilar candidate through the clinic. We believe we
have the opportunity to be the leader in offering patients a
biosimilar version of ORENCIA."
Mylan President Rajiv Malik
commented, "Our pipeline of biosimilar products, which is one of
the largest in development in the industry, continues to make
exciting advancements and today's milestone for M834 is yet another
example of this progress. Our partnership with Momenta is based not
only on a shared commitment to bringing more affordable versions of
critical biologic products to patients around the world, but also
on our mutual passion for science and R&D, and our willingness
to invest in it. To date, Mylan has invested more than $1 billion in our biologics and insulin analog
programs."
The Phase 1 study is a randomized, double-blind, three-arm,
parallel group, single-dose study that is expected to enroll
approximately 300 healthy volunteers. The companies plan to report
top-line data from this study by the end of 2017.
About M834, a proposed biosimilar of ORENCIA®
(abatacept)
M834 is developed in collaboration by Mylan N.V. and Momenta
Pharmaceuticals. ORENCIA is a fusion protein and the only CTLA-4Ig
approved in the US, EU and Japan
for the treatment of Rheumatoid Arthritis and the US and EU for the
treatment of Juvenile Idiopathic Arthritis. In 2015, worldwide
sales of ORENCIA totaled $1.9
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 M834 may be
approved and marketed; the cost-effectiveness and quality of our
biosimilars, including M834; the market potential for M834; the
timing of commercial launch of M834; the competitive landscape of
M834; and the timing of availability of clinical trial results.
Forward-looking statements may be identified by words such as
"believe," "opportunity," ""plan," "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 June 30,
2016 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 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
40,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
Forward Looking Statement for Mylan N.V.
This press release includes statements that constitute
"forward looking statements," including with respect to Mylan's
pipeline; future plans and intentions; biosimilar and insulin
programs; and expected timing for reporting on study results.
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 product candidates 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; 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.
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SOURCE Mylan N.V.