- Decision Clears Patents for Launch of GlatopaTM, the First Generic Version of Daily COPAXONE 20 mg Approved by the FDA -
CAMBRIDGE, Mass., June 18, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the United States Court of Appeals for the Federal Circuit ("CAFC") has again found that U.S. Patent No. 5,800,808, related to a method of manufacturing glatiramer acetate, is invalid as indefinite.
"We are very pleased with the Federal Circuit's decision to declare Teva's manufacturing process patent invalid once again," said Craig Wheeler, President and Chief Executive Officer of Momenta. "We look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis."
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 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 approval and launch 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 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 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