Momenta and Mylan Report Initial Results from Phase 1 Clinical Trial for M834, a Proposed Biosimilar of ORENCIA® (abatacept)...
November 01 2017 - 8:00AM
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V.
(NASDAQ:MYL) (TASE:MYL), today announced that M834, a proposed
biosimilar of ORENCIA (abatacept), did not meet its primary
pharmacokinetic (PK) endpoints in the Phase 1 study to compare the
pharmacokinetics, safety and immunogenicity of M834 to US- and
EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan
continue to gather and analyze these data to inform next steps for
the program.
“This was an unexpected result and we are
disappointed with the outcome of this PK study,” said Craig
Wheeler, President and Chief Executive Officer of Momenta
Pharmaceuticals. “We are in the process of gathering the full data
set and will work with Mylan to fully analyze these data to better
understand the study results and evaluate next steps for this
program. We remain committed to executing on our biosimilar
portfolio.”
The Phase 1 study was a randomized,
double-blind, three-arm, parallel group, single-dose subcutaneous
administration clinical study to compare the pharmacokinetics,
safety, and immunogenicity of M834, US-sourced ORENCIA, and
EU-sourced ORENCIA in 243 normal healthy volunteers.
About M834, a proposed biosimilar of ORENCIA®
(abatacept)M834 is part of the collaboration between 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 in the US and EU for the
treatment of Psoriatic Arthritis and Juvenile Idiopathic Arthritis.
In 2016, worldwide sales of ORENCIA totaled $2.4 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 future development and
commercialization plans for M834; and gathering and analyzing the
data from the Phase 1 study for M834 and understanding the results
thereof. Forward-looking statements may be identified by words and
phrases such as "believe," “continue,” “expect,” “evaluate,” “in
the process of gathering,” “opportunity,” “plan,” “will” 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, 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 approximately
50% of people being treated for HIV/AIDS in the developing world
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.
Forward Looking Statement For
MylanThis press release includes statements that
constitute "forward-looking statements," including with regard to
future development and commercialization plans for M834; and that
Momenta and Mylan continue to gather and analyze the data from the
Phase 1 study for M834 to inform next steps. 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 Investor ContactMelissa Trombetta
(Investor Relations)724-514-1813InvestorRelations@mylan.com
Mylan Media Contact
724-514-1968communications@mylan.com
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