Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc.
(Nasdaq:MNTA), today announced that M923 met the primary endpoint
in a randomized, double-blind, three-arm, parallel group,
single-dose study. The primary objective of the study was to
evaluate the pharmacokinetics of M923 compared to both U.S. and EU
sourced HUMIRA® reference products.
“We are encouraged by the results of this
study,” said John Orloff, M.D., head of Research & Development
and chief scientific officer, Baxalta. “We are committed to
expanding treatment access and providing additional options for
patients who suffer from chronic inflammatory diseases. We look
forward to bringing a biosimilar version of adalimumab to patients
around the world."
In addition to showing bioequivalence in
pharmacokinetics, this study also evaluated safety, tolerability
and immunogenicity following single doses of M923 given by
injection. The safety profile and immunogenicity were also found to
be comparable. A total of 324 healthy volunteers were enrolled in
the study.
“The results of this PK study further validate our ability to
develop high-quality biosimilar candidates using our complex
systems analysis platform,” said Jim Roach, M.D., Senior Vice
President of Development and Chief Medical Officer of Momenta
Pharmaceuticals. “We are pleased with the results seen to date and
expect that the data we generate from our ongoing pivotal trial in
patients with chronic plaque psoriasis will continue to support the
demonstration of biosimilarity of M923 to branded
HUMIRA.”
This milestone is part of a global collaboration
between Baxalta and Momenta to develop and commercialize M923. With
this collaboration, Baxalta leverages its leading clinical
development and biologic manufacturing expertise, and global
commercial capabilities, while Momenta provides its expertise in
high-resolution analytics, characterization, clinical and
regulatory strategy for complex products, and product and process
development.
Baxalta and Momenta announced the initiation of a separate
pivotal clinical trial of M923 in chronic plaque psoriasis in
October 2015. The companies are targeting a first regulatory
submission in 2017 and a first commercial launch as early as
2018.
About M923, a proposed biosimilar of HUMIRA®
(adalimumab)
M923 is developed in collaboration by Baxalta Incorporated and
Momenta Pharmaceuticals. 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.
About Baxalta
Baxalta Incorporated (NYSE:BXLT) is a $6 billion global
biopharmaceutical leader developing, manufacturing and
commercializing therapies for orphan diseases and underserved
conditions in hematology, oncology and immunology. Driven by
passion to make a meaningful impact on patients’ lives, Baxalta’s
broad and diverse pipeline includes biologics with novel mechanisms
and advanced technology platforms such as gene therapy. The Baxalta
Global Innovation and R&D Center is located in Cambridge,
Massachusetts. Launched in 2015 following separation from Baxter
International, Baxalta’s heritage in biopharmaceuticals spans
decades. Baxalta’s therapies are available in more than 100
countries and it has advanced biological manufacturing operations
across 12 facilities, including state-of-the-art recombinant
production and plasma fractionation. Headquartered in
Northern Illinois, Baxalta employs 16,000 employees worldwide.
Forward-Looking Statements for Baxalta
Incorporated
This release includes forward-looking statements concerning the
proposed biosimilar M923, including expectations with regard to
clinical trials, future regulatory actions, commercial launch plans
and potential impact on patients. Such statements are made of the
date that they were first issued and are based on current
expectations, beliefs and assumptions of management.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond Baxalta's control and which could cause actual results
to differ materially from those in the forward-looking statements,
including the following: clinical trial results; satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; changes in laws and regulations;
product quality, manufacturing or supply issues; patient safety
issues; and other risks identified in Baxalta's filings with the
Securities and Exchange Commission, all of which are available on
Baxalta's website. Baxalta expressly disclaims any intent or
obligation to update these forward-looking statements except as
required by law.
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 oncology and 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 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 statements about progressing M923 toward
regulatory approval and commercialization; timing of regulatory
submissions and commercial launch; the indications for which M923
may be approved and marketed; the cost-effectiveness of M923; and
the market potential for M923. Forward-looking statements may be
identified by words such as "anticipate," "believe," "continue,"
"could," "hope," "target," "project," "goal," "objective,"
"guidance," "plan," "potential," "predict," "might," "estimate,"
"expect," "intend," "may," "seek", "should," "will," "would," "look
forward" 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 September 30, 2015 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.
Baxalta Media Relations
Albert Liao, +1-617-834-9285, media@baxalta.com
Baxalta Investor Relations
Mary Kay Ladone, +1-224-948-3371, mary.kay.ladone@baxalta.com
Lorna Williams, +1-224-948-3511, lorna.williams@baxalta.com
Momenta Media Relations
Karen Sharma, MacDougall Biomedical Communications, +1-781-235-3060,
Momenta@macbiocom.com
Momenta Investor Relations
Sarah Carmody, +1-617-395-5189, IR@momentapharma.com
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