Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration
December 19 2022 - 6:30AM
Biogen Reaches Agreement with Genentech to Receive Royalties on the
Potential Commercialization of a Late-Stage Bispecific Antibody as
Part of Anti-CD20 Collaboration
Biogen Inc. (Nasdaq: BIIB) announced that it has reached an
agreement with Genentech, a member of the Roche Group, related to
the commercialization and sharing of economics for glofitamab.
Under the terms of the agreement, Biogen will have no payment
obligations and will receive tiered royalties on potential net
sales of glofitamab within the United States as part of the
companies long-standing 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 cancers1.
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. Food
and Drug Administration, 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 United States and, in
the event of approval, Biogen is eligible to receive tiered
royalties in the mid-single digits range on potential net sales of
glofitamab within the United States.
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.
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
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Biogen Safe Harbor This news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements about potential
clinical effects of glofitamab; the potential benefits, safety and
efficacy of glofitamab; the clinical development program for
glofitamab; the identification and treatment of B-cell
non-Hodgkin’s lymphomas; our collaboration with Genentech; the
potential of our commercial business and pipeline programs and
risks and uncertainties associated with drug development and
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of similar meaning. Drug development and commercialization involve
a high degree of risk and only a small number of research and
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Results in early stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
glofitamab; the risk that we may not fully enroll our clinical
trials or enrollment will take longer than expected; unexpected
concerns may arise from additional data, analysis or results
obtained during our clinical trials; regulatory authorities may
require additional information or further studies, or may fail or
refuse to approve or may delay approval of our drug candidates,
including glofitamab; the occurrence of adverse safety events; the
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References:
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https://www.gene.com/media/press-releases/14954/2022-05-26/new-pivotal-data-demonstrate-clinical-be
MEDIA
CONTACT:BiogenJack Cox+ 1 210 544
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INVESTOR
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