Momenta Pharmaceuticals Announces Global Settlement with AbbVie to Enable Commercialization of M923, a Proposed Biosimilar to...
November 06 2018 - 4:45PM
Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today announced
that it has executed agreements with AbbVie Inc., providing license
rights for the global launch of M923, Momenta’s proposed biosimilar
to HUMIRA. Under the terms of the agreements and subject to
approval by health regulatory authorities, Momenta may launch M923
in the United States (US) on November 20, 2023 and in Europe upon
approval by the European Medicines Agency. Momenta plans to submit
a biologics license application for M923 to the US Food and Drug
Administration in the fourth quarter of 2018 and a marketing
authorization application in the European Union in the first half
of 2019.
“We are pleased to have been able to work with
AbbVie on these agreements as they provide clarity as to when we
will have the opportunity to expand treatment access and provide an
additional high-quality option for patients who suffer from chronic
inflammatory diseases,” said Craig Wheeler, President and Chief
Executive Officer of Momenta.
Financial terms of this settlement are
confidential.
About MomentaMomenta is a
biotechnology company with a validated innovative scientific
platform focused on discovering and developing novel therapeutics
to treat rare, immune-mediated diseases. Momenta’s lead product
candidate, M281, is a potentially best-in-class anti-FcRn antibody;
M254, is a hyper-sialylated human immunoglobulin (hsIgG) designed
as a high potency alternative to intravenous immunoglobulin (IVIg);
and M230 (CSL730), is a potential first-in-class novel recombinant
Fc multimer being developed in collaboration with CSL. Momenta also
has a focused pipeline of two biosimilar candidates: M710, a
proposed biosimilar to EYLEA® being developed in collaboration with
Mylan, and M923, Momenta’s wholly-owned proposed biosimilar to
HUMIRA®. Momenta’s two FDA-approved complex generic products,
enoxaparin sodium injection and Glatopa® (glatiramer acetate
injection), are marketed by its collaboration partner, Sandoz.
To learn more about Momenta, please visit
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 Statements
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 statements about the timing of regulatory filings for,
development and commercialization plans for, including launch
dates, and the potential of M923. Forward-looking statements may be
identified by words such as "believe," "continue," “plan to”,
"potential," "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 important factors, including the risk that
the costs of the restructuring actions will exceed the Company’s
current expectations; the risk that the Company will not achieve
the anticipated cost savings from the restructuring actions; and
those referred to under the section "Risk Factors" in the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2018
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.
INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:Karen SharmaMacDougall Biomedical
Communications1-781-235-3060Momenta@macbiocom.com
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