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Press Release

Momenta Pharmaceuticals to Regain Global Development and Commercialization Rights to M923, a Proposed Biosimilar of HUMIRA® (adalimumab), Through Termination of Collaboration Agreement with Baxalta, Now Part of Shire

Posted on: 27 Sep 16

CAMBRIDGE, Mass., Sept. 27, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Shire has exercised its right to terminate its collaboration agreement with the Company to develop and commercialize M923, a proposed biosimilar of HUMIRA (adalimumab), based on a comprehensive portfolio assessment following the acquisition of Baxalta. Under the terms of the 2011 collaboration agreement, the agreement will terminate twelve months following the notice and Shire will continue to be obligated to fund the M923 program until termination. Shire will begin to work to transfer all ongoing clinical, regulatory and commercialization activities to Momenta.

“Baxalta has been a strong collaborative partner and we thank them for their efforts in advancing this important program through late-stage clinical development,” said Craig Wheeler, President and CEO of Momenta. “We view Shire’s decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders. We remain very excited about the potential for our biosimilar HUMIRA candidate and look forward to reporting top-line results of the current Phase 3 trial of M923 in late 2016.”

About M923, a proposed biosimilar of HUMIRA® (adalimumab)
HUMIRA, the largest selling therapeutic on the market today, is a significant intervention for patients with autoimmune/inflammatory diseases. Adalimumab is used to treat many such conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. M923 is currently in a Phase 3 pivotal trial in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA.

About Momenta Pharmaceuticals

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, 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 without limitation statements regarding future evaluation and development of M923 and the timing of availability and presentation of data from clinical trials, 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,” “initiative,” “potentially,” “strategy,” “target,” “will” 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 quarter ended June 30, 2016 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.


Last updated on: 28/09/2016

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