Momenta is using its proven technology platform to create biosimilars and potentially interchangeable biologics – a completely new segment of the biologics market. Biosimilars present us with the opportunity to build scale in our business by using our technology platform to develop multiple biosimilar products. Momenta currently has a robust portfolio of development and early-stage biosimilar candidates.
M923, a biosimilar HUMIRA® (adalimumab) candidate
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. We are targeting first regulatory submission for M923 in 2017 and a first commercial launch as early as 2018.
M834, a biosimilar ORENCIA® (abatacept) candidate
M834, a biosimilar version of ORENCIA, is our second most advanced biosimilar candidate. In January 2016, we entered into a collaboration with Mylan for the continued development, manufacture and commercialization of this biosimilar candidate. ORENCIA is a complex fusion protein drug approved for the treatment of moderate to severe rheumatoid arthritis in adults, as well as juvenile rheumatoid arthritis. These are inflammatory joint conditions causing joint pain, swelling, redness and morning stiffness. In November 2016, we initiated a Phase 1 clinical trial to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. In November 2017, we announced M834 did not meet its primary pharmacokinetic (PK) endpoints in the Phase 1 study, and that Momenta and Mylan continue to gather and analyze these data to inform next steps for the program.
Momenta's Biosimilar Portfolio
We also have a robust portfolio of additional undisclosed biosimilar product candidates in development. These candidates include monoclonal antibodies and fusion proteins. 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. Please view our press release announcing the collaboration with Mylan for more information.
HUMIRA® is a registered trademark of AbbVie. ORENCIA® is a registered trademark of Bristol-Myers Squibb.
Last Updated 11/2/2017