CAMBRIDGE, Mass., June 18, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that Sandoz has initiated its U.S. launch of once daily Glatopa™ (glatiramer acetate injection), a generic equivalent of daily COPAXONE® 20 mg, developed under a collaboration agreement between Momenta and Sandoz. Glatopa is the first AP-rated substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration.
Under the terms of its collaboration agreement with Sandoz, Momenta will receive a $10.0 million milestone payment upon first commercial sale. Momenta is also eligible to receive up to $120 million in remaining milestone payments upon the achievement of certain U.S. commercial and sales-based milestones for the Glatopa product.
Glatopa was determined by the FDA to be therapeutically equivalent to daily COPAXONE 20 mg, with the same active ingredients, route of administration, strength and dosage form. Glatopa's high quality U.S.-based supply chain and manufacturing process meet rigid FDA standards, and Glatopa is fully substitutable at the pharmacy level.
Sandoz has also introduced a patient support service offering that includes financial support to eligible patients, personalized injection training and 24-hour access to nurses to answer non-clinical questions.
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.
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. 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 Glatopa, including those about distribution and commercialization, pricing, potential sales or revenue, the achievement of milestones and receipt of associated payments under the Company's collaboration with Sandoz, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may contain such words 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. 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 month ended March 31, 2015 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 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