Utilizing its proven technology platform Momenta has developed biosimilar candidates
M923, a proposed biosimilar to HUMIRA® (adalimumab)
Our lead biosimilar candidate, M923 is a proposed HUMIRA biosimilar candidate. 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.
In October 2015, we initiated a pivotal clinical trial in patients with chronic plaque psoriasis for M923. The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. In December 2015, we announced that M923 met its primary endpoint in a pharmacokinetic study comparing M923 to both U.S. and EU sourced HUMIRA reference products. In November 2016, we announced that the confirmatory Phase 3 clinical study of M923 in patients with moderate-to-severe chronic plaque psoriasis met its primary endpoint.
In November 2018, Momenta reached a global settlement with AbbVie on the HUMIRA patent estate and expects to file a biologics license application (BLA) for M923 with the U.S. Food and Drug Administration in the 4th quarter 2018, a marketing authorization application in the European Union in the first half of 2019, and plans to work to identify a commercialization partner for this product candidate.
M710, a proposed biosimilar to EYLEA® (aflibercept) M710 is a proposed biosimilar to EYLEA and is being developed in collaboration with Mylan. EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema (DME) following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in patients with diabetic macular edema. In August 2018 Mylan initiated a Phase 3 pivotal trial in patients with DME.
Momenta's Biosimilar Portfolio In January 2016, we entered into a broad global collaboration with Mylan for the development, manufacture and commercialization of five of our biosimilar product candidates. In October 2018, Momenta announced a corporate restructuring that intends to focus solely on the continued development of M710 in partnership with Mylan, and plans to exit its participation in the development of its other five biosimilar programs including M834, a proposed biosimilar to ORENCIA®.
HUMIRA® is a registered trademark of AbbVie. ORENCIA® is a registered trademark of Bristol-Myers Squibb. EYLEA® (aflibercept) is a registered trademark of Regeneron.
Last Updated 11/7/2018