Momenta and Mylan Initiate Phase 1 Clinical Trial for M834, a Proposed Biosimilar of ORENCIA® (abatacept)
"We are deeply committed to expanding treatment access and providing high-quality and affordable biosimilar options for patients who suffer from autoimmune and inflammatory diseases," said
The Phase 1 study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017.
About M834, a proposed biosimilar of ORENCIA® (abatacept)
M834 is developed in collaboration by
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.
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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 the indications for which M834 may be approved and marketed; the cost-effectiveness and quality of our biosimilars, including M834; the market potential for M834; the timing of commercial launch of M834; the competitive landscape of M834; and the timing of availability of clinical trial results. Forward-looking statements may be identified by words such as "believe," "opportunity," ""plan," "target" 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, 2016 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.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
This press release includes statements that constitute "forward looking statements," including with respect to Mylan's pipeline; future plans and intentions; biosimilar and insulin programs; and expected timing for reporting on study results. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring product candidates to market; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in
Momenta Investor Contact Sarah Carmody Momenta Pharmaceuticals 1-617-395-5189 IR@momentapharma.com Momenta Media Contact
Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com Mylan Contact Nina Devlin(Media), 724.514.1968 Kris King(Investors), 724.514.1813
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