Momenta Pharmaceuticals Announces FDA Approval and Launch of Glatopa® (glatiramer acetate injection) 40 mg/mL
February 13 2018 - 1:15AM
--Glatopa 40 mg/mL is a fully substitutable,
AP-rated generic version of three times-a-week COPAXONE®
(glatiramer acetate injection) 40 mg/mL for the treatment of
patients with relapsing forms of multiple sclerosis (MS)--
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced
that the U.S. Food and Drug Administration (FDA) has approved
Sandoz’s Abbreviated New Drug Application for Glatopa (glatiramer
acetate injection) 40 mg/mL and that Sandoz has initiated the
launch of this product in the US. Glatopa was developed under a
collaboration agreement between Momenta and Sandoz and is produced
in the US.
Glatopa 40 mg/mL is FDA-approved as a fully
substitutable, AP-rated generic version of three times-a-week
COPAXONE 40 mg/mL therapy for patients with relapsing forms of
multiple sclerosis (MS). In April 2015, the collaboration’s Glatopa
20 mg/mL product received FDA approval and remained the only
generic glatiramer acetate product on the market for over two
years.
“This approval further validates the strength of
our physicochemical and biological characterization capabilities,”
said Craig A. Wheeler, President and Chief Executive Officer of
Momenta Pharmaceuticals. “We are very proud to once again be able
to provide patients with relapsing-forms of MS with a cost
effective, high-quality generic alternative treatment option.”
Momenta will provide a corporate update,
including an update on the approval and launch of Glatopa 40 mg, at
the Leerink Partners 7th Annual Global Healthcare Conference on
Thursday, February 15, 2018 at 10:00 a.m. ET and as part of the
Company’s fourth quarter and year end 2017 financial results
conference call on Wednesday, February 21, 2018 at 10:00 a.m. ET. A
live webcast of both events will be available on the "Investors"
section of the company's website, www.momentapharma.com.
About Glatopa® 40 mg/mL (glatiramer
acetate injection)
Glatopa 40 mg/mL, developed in collaboration
with Sandoz, is a FDA-approved generic version of three
times-a-week COPAXONE® 40 mg/mL for patients with relapsing forms
of multiple sclerosis (MS). Produced entirely in the United States,
Glatopa 40 mg/mL has been determined by the FDA to be
therapeutically equivalent to three times-a-week COPAXONE 40 mg/mL,
and is an “AP” rated, fully-substitutable product. As a
therapeutically equivalent generic product, Glatopa 40 mg/mL
contains the same active ingredients, route of administration,
strength, and dosage form, and can be substituted with the full
expectation that Glatopa 40 mg/mL will produce the same clinical
effect and safety profile as three times-a-week COPAXONE 40 mg/mL.
Three times-a-week COPAXONE 40 mg/mL is one of the leading products
marketed to treat MS, 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 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
StatementStatements 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 Glatopa, including those
about distribution and commercialization and statements
regarding pricing of Glatopa are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements may contain such words as
"potential,” "look forward,” "expected" or similar terms. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors referred to in the Company's
Quarterly Report on Form 10-Q for the quarter ended September
30, 2017 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 the date of this press
release 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 registered trademark of Novartis
AG.
MOMENTA INVESTOR CONTACT:Sarah CarmodyMomenta
Pharmaceuticals1-617-395-5189IR@momentapharma.com
MOMENTA MEDIA CONTACT:Karen SharmaMacDougall Biomedical
Communications1-781-235-3060Momenta@macbiocom.com
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