Momenta Pharmaceuticals Announces Global Settlement with AbbVie to Enable Commercialization of M923, a Proposed Biosimilar to HUMIRA® (adalimumab)
- Category: Antibodies
- Published on Wednesday, 07 November 2018 13:40
- Hits: 414
CAMBRIDGE, MA, USA I November 06, 2018 I Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today announced that it has executed agreements with AbbVie Inc., providing license rights for the global launch of M923, Momenta’s proposed biosimilar to HUMIRA. Under the terms of the agreements and subject to approval by health regulatory authorities, Momenta may launch M923 in the United States (US) on November 20, 2023 and in Europe upon approval by the European Medicines Agency. Momenta plans to submit a biologics license application for M923 to the US Food and Drug Administration in the fourth quarter of 2018 and a marketing authorization application in the European Union in the first half of 2019.
“We are pleased to have been able to work with AbbVie on these agreements as they provide clarity as to when we will have the opportunity to expand treatment access and provide an additional high-quality option for patients who suffer from chronic inflammatory diseases,” said Craig Wheeler, President and Chief Executive Officer of Momenta.
Financial terms of this settlement are confidential.
Momenta is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases. Momenta’s lead product candidate, M281, is a potentially best-in-class anti-FcRn antibody; M254, is a hyper-sialylated human immunoglobulin (hsIgG) designed as a high potency alternative to intravenous immunoglobulin (IVIg); and M230 (CSL730), is a potential first-in-class novel recombinant Fc multimer being developed in collaboration with CSL. Momenta also has a focused pipeline of two biosimilar candidates: M710, a proposed biosimilar to EYLEA® being developed in collaboration with Mylan, and M923, Momenta’s wholly-owned proposed biosimilar to HUMIRA®. Momenta’s two FDA-approved complex generic products, enoxaparin sodium injection and Glatopa® (glatiramer acetate injection), are marketed by its collaboration partner, Sandoz.
SOURCE: Momenta Pharmaceuticals