Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and Mylan(NASDAQ, TASE: MYL) today announced the development strategy for M710, a proposed biosimilar to EYLEA® (aflibercept) injection. EYLEA is the market-leading vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema. The companies plan to initiate a pivotal clinical trial in patients in the first half of 2018.
This trial is a randomized, double-blind, active-control, multi-center study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with EYLEA.
"Expanding treatment access and providing high-quality, affordable drugs for patients is a key attribute of our biosimilars business and an important business objective at Momenta. We believe our proposed biosimilar to EYLEA, in collaboration with Mylan, is an attractive program with limited biosimilar competition, which could result in a first to market advantage," said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals.
Mylan President Rajiv Malik commented, "Advancing a biosimilar to EYLEA to the clinical trial period in the first half of the year is an exciting milestone in the development of this important product. We are proud of the significant investments we've made in building one of the industry's most robust biosimilar pipelines, and we look forward to being at the forefront of offering patients a more affordable version of this complex product."
About M710, a proposed biosimilar of EYLEA® (aflibercept)
M710 is developed in collaboration by Mylan N.V. and Momenta Pharmaceuticals. EYLEA is the market-leading vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion and diabetic retinopathy in patients with DME. In 2016, global net sales of EYLEA were $5.2 billion.
About Momenta
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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Forward Looking Statement For Momenta Pharmaceuticals
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 M710 may be approved and marketed; the cost-effectiveness and quality of our biosimilars, including M710; the market potential for M710; the timing of approval or commercial launch of M710; the competitive landscape of M710; and the timing of availability of clinical trial results. Forward-looking statements may be identified by words such as "believe," "could," "objective", "opportunity," ""plan," "strategy," "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 September 30, 2017 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 fact...
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