Biogen Exercises Option to Participate in the Development and Commercialization of a Late-Stage Bispecific Antibody
February 01 2022 - 7:30AM
Biogen Exercises Option to Participate in the Development and
Commercialization of a Late-Stage Bispecific Antibody
Biogen Inc. (Nasdaq: BIIB) today announced that it exercised its
option to participate in the development and commercialization of
mosunetuzumab. Biogen will pay a $30 million one-time option fee to
Genentech, a member of the Roche Group, as part of the companies’
long-standing collaboration on antibodies targeting CD20.
Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody
in development for the treatment of people with B-cell
non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL)1
and diffuse large B-cell lymphoma (DLBCL). In June 2020,
mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by
the U.S. Food and Drug Administration (FDA) for the treatment of
adult patients with relapsed/refractory (R/R) FL who have received
at least two prior systemic therapies.
Genentech plans to complete a Biologics License Application
(BLA) submission to the FDA in the near future for approval
consideration from the GO29781 study investigating mosunetuzumab in
patients with R/R FL. If approved, mosunetuzumab has the potential
to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody
in NHL. Roche recently submitted the initial marketing
authorization application for mosunetuzumab to the European
Medicines Agency (EMA), with the hope to bring this drug as soon as
possible to people with NHL. In addition, mosunetuzumab recently
began a Phase 1b trial in patients with systemic lupus
erythematosus2.
As a part of the option exercise, Biogen will pay a $30 million
one-time option fee to Genentech and will pay for a portion of the
mosunetuzumab development expenses incurred during 2021. Biogen
will have joint decision-making rights related to development and
commercialization of mosunetuzumab and Genentech will continue to
lead the strategy and implementation of the program.
Biogen will share in the operating profits and losses of
mosunetuzumab in United States in the low to mid 30% range and is
eligible to receive low single-digit royalties on sales outside the
United States.
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 is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
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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 mosunetuzumab; the potential benefits, safety
and efficacy of mosunetuzumab; the clinical development program for
mosunetuzumab; the identification and treatment of non-Hodgkin’s
lymphoma or lupus; our research and development program for the
treatment of non-Hodgkin’s lymphoma or lupus; the potential of our
commercial business and pipeline programs, including mosunetuzumab;
and risks and uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk and only a small number of research and
development programs result in commercialization of a product.
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
mosunetuzumab; 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 mosunetuzumab; the occurrence of adverse safety events;
the risks of unexpected hurdles, costs or delays; failure to
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foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from our expectations in any
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statements are based on our current beliefs and expectations and
speak only as of the date of this news release.We do not undertake
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whether as a result of new information, future developments or
otherwise.
References:
-
https://www.gene.com/media/press-releases/14938/2021-12-11/genentech-presents-pivotal-data-at-ash-2
- https://clinicaltrials.gov/ct2/show/NCT05155345
MEDIA CONTACT:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.com |
INVESTOR CONTACT:BiogenMike Hencke+1 781 464
2442IR@biogen.com |
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