Momenta Presents Key Glatopa(TM) (glatiramer acetate injection) Data at American Academy of Neurology Annual Meeting
April 20 2015 - 8:00AM
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today presented new data from studies conducted as
part of the ANDA submission for once daily Glatopa (glatiramer
acetate injection) at the 67th American Academy of Neurology (AAN)
Annual Meeting in Washington D.C. The posters presented provide
examples of a selection of methods the Company utilized to show the
equivalence of Glatopa and once daily COPAXONE 20 mg.
Momenta Presentation Highlights: Poster #P1.144
– Comparative Gene Expression Profiling between a Generic (Glatopa)
and Brand COPAXONE (glatiramer acetate injection)
- Microarray analysis across the entire genome was performed in
murine glatiramer acetate-responsive Th2-polarized T cells, a test
system highly relevant to the biology of glatiramer acetate.
Multiple statistical methods consistently demonstrated assay
sensitivity as well as equivalent gene expression profiles between
Glatopa and Copaxone.
Poster #P1.145 – Demonstration of Equivalence between a Generic
(Glatopa) and Brand COPAXONE (glatiramer acetate injection)
- This poster summarized Momenta's overall approach of
comparison, as well as multiple examples of equivalence of starting
materials and basic chemistry; equivalence of structural
manufacturing process signatures; equivalence of physicochemical
(structural) properties; and equivalence of
biological/immunological (functional) properties.
The selected assays and data presented at AAN are examples of
the extensive physicochemical methods and biological/immunological
assays that were submitted to the FDA as part of the recently
approved data package for Glatopa.
"These posters not only provide examples of the comprehensive
program we conducted to evaluate the equivalence of Glatopa and
daily COPAXONE 20 mg, these data also further validate Momenta's
ability to deeply characterize complex drugs and disease biologies
and develop high-quality drugs," said Ganesh V. Kaundinya, Chief
Scientific Officer of Momenta Pharmaceuticals.
About GlatopaTM Once daily Glatopa (glatiramer
acetate injection), developed in collaboration with Sandoz, is the
first FDA-approved generic version of daily COPAXONE® 20 mg for
patients with relapsing forms of multiple sclerosis. Produced
entirely in the United States, once daily Glatopa has been
determined by the FDA to be therapeutically equivalent to daily
COPAXONE 20 mg, and is an "AP" rated, fully-substitutable product.
As a therapeutically equivalent generic product, once daily Glatopa
contains the same active ingredients, route of administration,
strength, and dosage form, and can be substituted with the full
expectation that Glatopa will produce the same clinical effect and
safety profile as daily COPAXONE 20 mg. Daily COPAXONE 20 mg is one
of the leading products marketed to treat multiple sclerosis, and
is frequently prescribed as a first-line therapy in newly diagnosed
patients.
About Momenta Momenta Pharmaceuticals is a
biotechnology company specializing in the detailed structural and
functional 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. 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
statements relating to its beliefs and intentions related to the
marketing approval, launch and commercialization of our Glatopa
product, 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,"
"believe," "could," "could increase the likelihood," "hope,"
"target," "project," "goals," "potential," "predict," "might,"
"estimate," "expect," "intend," "is planned," "may," "should,"
"will," "will enable," "would be expected," "look forward," "may
provide," "would" 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 Annual Report on Form 10-K for the
year ended December 31, 2014 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.
COPAXONE is a registered trademark of Teva Pharmaceuticals.
Glatopa is a trademark of Novartis AG.
CONTACT: 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
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Apr 2023 to Apr 2024