Momenta Pharmaceuticals to Regain Global Development and Commercialization Rights to M923, a Proposed Biosimilar of HUMIRA® ...
September 27 2016 - 8:00AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today announced that Shire has exercised its right
to terminate its collaboration agreement with the Company to
develop and commercialize M923, a proposed biosimilar of HUMIRA
(adalimumab), based on a comprehensive portfolio assessment
following the acquisition of Baxalta. Under the terms of the 2011
collaboration agreement, the agreement will terminate twelve months
following the notice and Shire will continue to be obligated to
fund the M923 program until termination. Shire will begin to work
to transfer all ongoing clinical, regulatory and commercialization
activities to Momenta.
“Baxalta has been a strong collaborative partner
and we thank them for their efforts in advancing this important
program through late-stage clinical development,” said Craig
Wheeler, President and CEO of Momenta. “We view Shire’s decision as
a significant opportunity for us to capture additional value from
this program for the Company and its shareholders. We remain very
excited about the potential for our biosimilar HUMIRA candidate and
look forward to reporting top-line results of the current Phase 3
trial of M923 in late 2016.”
About M923, a proposed biosimilar of
HUMIRA® (adalimumab)HUMIRA, the largest selling
therapeutic on the market today, is a significant intervention for
patients with autoimmune/inflammatory diseases. Adalimumab is used
to treat many such conditions including rheumatoid arthritis,
juvenile idiopathic arthritis, psoriatic arthritis, ankylosing
spondylitis, Crohn's disease, ulcerative colitis and plaque
psoriasis. M923 is currently in a Phase 3 pivotal trial in patients
with chronic plaque psoriasis to compare the safety, efficacy and
immunogenicity of M923 with HUMIRA.
About Momenta Pharmaceuticals
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. The company's 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 Statements
Statements in this press release regarding
management's future expectations, beliefs, intentions, goals,
strategies, plans or prospects, including without limitation
statements regarding future evaluation and development of M923 and
the timing of availability and presentation of data from clinical
trials, are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by
terminology such as “anticipate,” “initiative,” “potentially,”
“strategy,” “target,” “will” or similar terms, variations of such
terms or the negative of those terms. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors referred to in the Company's Quarterly Report on Form 10-Q
for the quarter ended June 30, 2016 filed with
the Securities and Exchange Commission under the section
"Risk Factors," as well as other documents that may be filed by
Momenta 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. Momenta 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.
Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
Business Development:
Momenta Pharmaceuticals
1-617-491-9700
businessdevelopment@momentapharma.com
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