Date: 2016-09-27
Type of information: Termination of the agreement
Compound: M923, a biosimilar version of Humira® (adalimumab)
Company: Momenta Pharmaceuticals (USA - MA) Shire (UK - USA)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Type agreement: licensing
Action mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor. M923 is a biosimilar version of Humira® (adalimumab), the largest selling therapeutic on the market today, Humira® is a transformative therapy for patients with autoimmune diseases and inflammatory diseases. Humira® is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. M923 is developed in collaboration by Momenta and Baxalta, now part of Shire.
Disease:
Details: * On September 27, 2016, Momenta Pharmaceuticals announced that Shire has exercised its right to terminate its collaboration agreement with the company to develop and commercialize M923, a proposed biosimilar of Humira® (adalimumab), based on a comprehensive portfolio assessment following the acquisition of Baxalta. Under the terms of the 2011 collaboration agreement, the agreement will terminate twelve months following the notice and Shire will continue to be obligated to fund the M923 program until termination. Shire will begin to work to transfer all ongoing clinical, regulatory and commercialization activities to Momenta. M923 is currently in a phase 3 pivotal trial in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with Humira®. Momenta Pharmaceuticals looks forward to reporting top-line results of the current Phase 3 trial of M923 in late 2016.
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