Momenta and Mylan Announce Development Strategy for M710, a Proposed Biosimilar to EYLEA® (aflibercept)

Targeting the initiation of a pivotal patient clinical trial in the first half of 2018

CAMBRIDGE, MA, USA, HERTFORDSHIRE, UK and PITTSBURGH, PA, USA I January 03, 2018 I Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) and Mylan N.V. (NASDAQ:MYL) (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.

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 Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

SOURCE: Mylan

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