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Biogen will have no payment obligations and will receive tiered royalties on potential sales of glofitamab in the U.S.
December 19, 2022
By: Kristin Brooks
Managing Editor, Contract Pharma
Biogen Inc. has reached an agreement with Genentech, Inc., a member of the Roche Group, related to the commercialization for glofitamab. Under the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential sales of glofitamab in the U.S. as part of the companies collaboration on antibodies targeting CD20. Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody being developed by Roche for the treatment of B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, and other blood cancers. Glofitamab is based on a novel structural format called ‘2:1’, which is engineered to have two ‘Fab’ regions that bind to CD20 and one ‘Fab’ region which binds to CD3. This dual targeting activates and redirects a patient’s own T-cells to engage and eliminate cancer B cells. Data from the Phase II NP30179 study investigating glofitamab in patients with relapsed/refractory (R/R) DLBCL have been submitted for review to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including the U.S. FDA, are ongoing. If approved, glofitamab has the potential to be a first-in-class fixed-duration CD20xCD3 T-cell engaging bispecific antibody in DLBCL. Genentech will have sole decision-making rights on the commercialization of glofitamab within the U.S. and, if approved, Biogen is eligible to receive tiered royalties on potential sales of glofitamab within the U.S. Glofitamab, together with mosunetuzumab, is part of the Roche and Genentech CD20xCD3 antibody portfolio that seeks to address the unmet needs of people living with blood cancers. In January 2022, Biogen exercised the option to have joint decision-making rights related to the development and potential commercialization of mosunetuzumab, and Genentech will continue to lead the strategy and implementation of the program. The companies have had a collaboration on antibodies targeting CD20 since 1995.
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