Baxalta Incorporated (NYSE:BXLT) and Momenta
Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced the
initiation of a pivotal clinical trial in patients with chronic
plaque psoriasis for M923, a biosimilar version of HUMIRA®
(adalimumab). The trial is a randomized, double blind, active
control, multi-center, global study in patients with chronic plaque
psoriasis to compare the safety, efficacy and immunogenicity of
M923 with HUMIRA. The companies are targeting first regulatory
submission in 2017 and a first commercial launch in 2018.
“We are committed to expanding treatment access and providing
additional options for patients who suffer from chronic plaque
psoriasis,” said Dagmar Rosa-Bjorkeson, executive vice president
and president, Biosimilars, Baxalta. “Chronic plaque psoriasis is a
debilitating disease that can have a significant impact on a
patient’s quality of life and physical wellbeing. We look forward
to bringing a high-quality and cost-effective biosimilar version of
adalimumab to patients around the world.”
Chronic plaque psoriasis is the most common form of psoriasis
that affects one to three percent of the general population1. It is
characterized by scaly plaques or lesions on the body and the
scalp, which may itch or sting, and can bleed when injured. Though
there are treatments available, there is no cure for psoriasis.
“We believe that our extensive analytical and
biocharacterization work has allowed us to create a high-quality
biosimilar candidate of HUMIRA,” said Jim Roach, M.D., Senior Vice
President of Development and Chief Medical Officer of Momenta
Pharmaceuticals. “We look forward to progressing M923 toward
regulatory approval and commercialization with our collaborative
partner Baxalta and to the potential of providing a more affordable
biosimilar option for the many patients suffering from chronic
autoimmune and inflammatory diseases.”
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,
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.
About M923, a proposed biosimilar of HUMIRA®
(adalimumab)
M923 is developed in collaboration by Momenta and Baxalta
Incorporated. 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
This release includes forward-looking statements concerning
M923, a proposed biosimilar of HUMIRA, including expectations with
regard to clinical trials, future regulatory actions and
commercialization plans, and its 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 Registration Statement on Form 10 and other Securities
and Exchange Commission filings, 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 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 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 June 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.
References
- Naldi, L and Rzany, B. Psoriasis (chronic plaque). British
Medical Journal of Clinical Evidence. 2009 Jan 9; 1706.
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 Investor Contact
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Momenta Media Contact
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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