Momenta Pharmaceuticals Announces FDA Approval and Launch of Glatopa® (glatiramer acetate injection) 40 mg/mL
--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)--
--Glatopa 40 mg/mL joins the
Glatopa 40 mg/mL is
“This approval further validates the strength of our physicochemical and biological characterization capabilities,” said
Momenta will provide a corporate update, including an update on the approval and launch of Glatopa 40 mg, at the
About Glatopa® 40 mg/mL (glatiramer acetate injection)
Glatopa 40 mg/mL, developed in collaboration with
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.
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Forward Looking Statement
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 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
MOMENTA INVESTOR CONTACT:
MOMENTA MEDIA CONTACT:
MacDougall Biomedical Communications
Source: Momenta Pharmaceuticals, Inc.