Baxalta and Momenta Announce Initiation of Pivotal Clinical Trial for M923, a Biosimilar Version of HUMIRA (adalimumab)
"We are committed to expanding treatment access and providing additional options for patients who suffer from chronic plaque psoriasis," said
Chronic plaque psoriasis is the most common form of psoriasis that affects one to three percent of the general population1. It is characterized by scaly plaques or lesions on the body and the scalp, which may itch or
"We believe that our extensive analytical and biocharacterization work has allowed us to create a high-quality biosimilar candidate of HUMIRA," said
This milestone is part of a global collaboration between
About M923, a proposed biosimilar of HUMIRA® (adalimumab)
M923 is developed in collaboration by
Forward Looking Statements For Baxalta
This release includes forward-looking statements concerning M923, a proposed biosimilar of HUMIRA, including expectations with regard to clinical trials, future regulatory actions and commercialization plans, and its potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking
statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond
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.
Our logo, trademarks, and service marks are the property of
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about progressing M923 toward regulatory approval and commercialization; timing of regulatory submissions and commercial launch; the indications for which M923 may be approved and marketed; the cost-effectiveness of M923; and the market potential for M923. Forward-looking statements may be identified by words such as "anticipate," "believe," "continue," "could," "hope," "target," "project," "goal," "objective," "guidance," "plan," "potential," "predict," "might," "estimate," "expect," "intend," "may," "seek", "should," "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, including those referred to under the section "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company 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. The Company 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.
- Naldi, L and Rzany, B. Psoriasis (chronic plaque).
British Medical Journal of Clinical Evidence. 2009 Jan 9; 1706.
Baxalta Media Relations
Albert Liao, +1-617-834-9285, email@example.com Baxalta Investor Relations Mary Kay Ladone, +1-224-948-3371, firstname.lastname@example.org Lorna Williams, +1-224-948-3511, email@example.com Momenta Investor Contact Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com Momenta Media Contact Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
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