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Momenta Pharmaceuticals Announces Publication Revealing Development of a Novel Process to Generate High-Quality Hyper-sialylated IVIg Drug Candidate in PNAS

CAMBRIDGE, Mass., March 2, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that results from preclinical studies on its hyper-sialylated IVIg (hsIVIg) program were published in this week's Early Edition of Proceedings of the National Academy of Sciences (PNAS). The article summarizes Momenta's progress in creating a hsIVIg drug candidate with the potential for more consistent and enhanced anti-inflammatory activity compared to the current IVIg therapy used to treat inflammatory and autoimmune diseases.

"These studies demonstrate the important progress we have made in translating the concept of the anti-inflammatory properties of Fc-sialylation into a potential therapeutic alternative to current IVIg therapy," said Ganesh Kaundinya, Ph.D., Chief Scientific Officer of Momenta Pharmaceuticals, Inc. "The preclinical data from these studies indicate that hsIVIg can provide consistent, enhanced anti-inflammatory activity up to ten-fold higher than IVIg in animal models of diseases such as arthritis, immune thrombocytopenia (ITP) and skin blistering diseases. We look forward to identifying the right partner to advance what we believe to be the first hyper-sialylated product candidate with the potential for use in the clinic."

IVIg therapy has demonstrated beneficial therapeutic effects and is often used as a last line of defense in many severe inflammatory diseases. Although efficacious in these diseases, inconsistent efficacy and potency remain as major limitations for patients and physicians using IVIg. The identification of the important anti-inflammatory role of Fc-sialylation has presented the opportunity to develop a more potent alternative therapy to IVIg; however, translating this finding into a more potent anti-inflammatory product has been hampered by the difficulty of generating sialylated products suitable for clinical use. Momenta utilized its expertise in the characterization and engineering of complex biologics to develop a robust and scalable process to generate a hyper-sialylated IVIg drug candidate for potential clinical development.

The article is entitled "Controlled Tetra-Fc Sialylation of IVIg Results in a Drug Candidate with Consistent Enhanced Anti-inflammatory Activity" and is available at http://www.pnas.org/cgi/doi/10.1073/pnas.1422481112.

About Hyper-sialylated IVIg (hsIVIg)
Intravenous immunoglobulin (IVIg), a mixture of human immunoglobulin antibodies prepared from pooled human plasma, is used to treat primary immunodeficiencies as well as a wide variety of autoimmune and inflammatory diseases. Despite its therapeutic benefits, IVIg preparations have limitations such as variable efficacy, limited potency, clinical risks, high costs, patient inconvenience and finite supply. Momenta has created a robust and scalable process to generate a hyper-sialylated IVIg drug candidate called hsIVIg. Preclinical studies show that Momenta's hsIVIg drug candidate provides more consistent and potent anti-inflammatory activity and thus may have the potential to serve as a valuable therapeutic alternative to IVIg for the treatment of autoimmune and inflammatory diseases.

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.

Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding management's expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements about future clinical studies and clinical study results for hsIVIg and partnering the hsIVIg program, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can sometimes be identified by words such as "anticipate," "believe," "continue," "could," "hope," "target," "project," "goal," "objective," "plan," "potential," "predict," "might," "estimate," "expect," "intend," "may," "seek", "should," "target," "will," "would," "look forward" and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Important factors include Momenta's ability to fund and successfully conduct clinical trials of its hsIVIg product candidate, either independently or in collaboration with a partner; the possibility of unfavorable or disappointing clinical trial results; Momenta's ability to successfully partner the hsIVIg program; and the factors listed under "Risk Factors" in Momenta's Annual Report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission, as well as other documents that may be filed by Momenta from time to time with the SEC. Momenta is providing the information in this press release as of the date hereof 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.

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

Source:Momenta Pharmaceuticals