Momenta Pharmaceuticals Announces Positive Top-Line Phase 3 Results for M923, a Proposed HUMIRA® (adalimumab) Biosimilar
November 29 2016 - 8:00AM
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced
that the confirmatory Phase 3 clinical study of M923, a biosimilar
HUMIRA® (adalimumab) candidate developed in collaboration with
Baxalta, now part of Shire plc, in patients with moderate-to-severe
chronic plaque psoriasis, met its primary endpoint. The proportion
of subjects in the study who achieved the primary endpoint, at
least 75% reduction in the Psoriasis Area and Severity Index
(PASI-75) following 16 weeks of treatment, was equivalent between
M923 and HUMIRA. The estimated difference in responders was well
within the pre-specified confidence interval, confirming
equivalence.
Equivalence was also achieved in all secondary
efficacy endpoints, including the achievement of PASI-50, PASI-90,
proportion achieving clear or near-clear skin, and change from
baseline in absolute PASI score. Adverse events were comparable in
terms of type, frequency, and severity, and were consistent with
the published safety data for HUMIRA.
“These positive data support the biosimilarity
of M923, and further advance us toward our goal of gaining
regulatory approval for this important program,” said Craig A.
Wheeler, President and Chief Executive Officer of Momenta
Pharmaceuticals. “These data also validate the strength of our
technology and show our commitment to expanding treatment access
and providing additional options for patients who suffer from
chronic inflammatory diseases.”
This was a confirmatory, randomized,
double-blind, multicenter study evaluating the efficacy, safety and
immunogenicity of M923 in adult patients with moderate-to-severe
chronic plaque psoriasis. Patients received up to 48 weeks of
treatment with M923, HUMIRA, or HUMIRA alternating with M923. The
full dataset from this study will be presented at future
conferences and in future publications.
In 2011, Momenta Pharmaceuticals and Baxter
Bioscience (subsequently Baxalta), now part of Shire, entered into
the collaboration to develop and commercialize M923. Earlier this
year, Shire announced it had made a strategic decision to end its
biosimilars program and is now in the process of transitioning M923
to Momenta Pharmaceuticals, enabling Shire to further pursue its
focus on serving people with rare diseases and other highly
specialized conditions.
About M923, a proposed biosimilar of
HUMIRA® (adalimumab)
M923 is being developed as a biosimilar
candidate for HUMIRA, an anti-TNF monoclonal antibody. 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, plaque psoriasis, hidradenitis suppurativa and
uveitis.
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 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 development
goals and regulatory approval goals for M923; commercial
availability and effectiveness of M923; and the expectations about
the analysis, clinical significance and future presentation of the
full dataset from the Phase 3 study. Forward-looking
statements may be identified by words such as “continue,” “expect,”
“guidance,” “look forward,” “opportunity,” “plan,” “potential,”
“schedule,” “target,” “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 the
Company’s ability to fund the M923 program and obtain necessary
regulatory approvals and the outcome of related patent litigation
and patent-related proceedings, as well as those factors set forth
in the section “Risk Factors” in the Company's Quarterly Report on
Form 10-Q for the quarter ended September 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.
INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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