Biogen and Xbrane Announce Commercialization and License Agreement
for Proposed Biosimilar Referencing CIMZIA® (Certolizumab pegol)
with the Potential to Treat Rheumatoid Arthritis
Biogen Inc. (Nasdaq: BIIB) and Xbrane Biopharma AB (STO: XBRANE)
today announced that they have entered into a commercialization and
license agreement to develop, manufacture, and commercialize
Xcimzane™, a preclinical monoclonal antibody that is a proposed
biosimilar referencing CIMZIA® (certolizumab pegol)1.
CIMZIA®’s primary indication is for rheumatoid arthritis in
adults as well as axial spondylarthrosis, psoriasis and Crohn’s
disease. In 2020 global sales of CIMZIA® were 1.8 billion Euro2.
Under the terms of the agreement, Biogen will gain exclusive global
regulatory, manufacturing, and commercial rights to
Xcimzane™ and will be the Marketing Authorization Holder. “We
aim to bring more biosimilars products to more patients and more
geographies and we are excited to bring this additional asset to
our Biosimilars pipeline,” said Ian Henshaw, Head of Global
Biosimilars at Biogen. “This preclinical biosimilar candidate has
the potential to add another option for patients living with
Rheumatoid Arthritis and other indications.”
“Given their vast development and commercialization experience,
we are convinced that Biogen is the best possible partner we could
have for Xcimzane™,” said Martin Åmark, CEO of Xbrane Biopharma AB.
“Today’s announcement confirms Xbrane’s ambition to become a global
biosimilar developer.”
Under the terms of the agreement, Biogen will make an upfront
payment of $8 million to Xbrane. Should certain development and
commercial milestones be achieved, Xbrane will be eligible to
receive up to $80 million in potential milestone payments. Xbrane
is also eligible to receive tiered royalties. Xbrane will be
responsible for the completion of pre-clinical development of
Xcimzane™ and Biogen will be responsible for all remaining
development activities and costs required to achieve Marketing
Authorization in all territories, including those for clinical
development.About BiosimilarsBiosimilars are
biologic products that have been demonstrated to be similar in
efficacy, safety and immunogenicity to the originator’s approved
reference product, with the advantage that they can offer
significant cost savings. Biosimilars may lower healthcare system
costs broadly, creating headroom for innovation and could enable
governments to potentially redirect savings to priorities such as
increasing access to transformative therapies.
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
investors on its website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen on social
media
– Twitter, LinkedIn, Facebook, YouTube.
About Xbrane Biopharma ABXbrane Biopharma AB
develops biological drugs based on a patented platform technology
that provides significantly lower production costs compared to
competing systems. Xbrane has a portfolio of biosimilar candidates
targeting €11 billion in annual sales of the respective reference
products, with the leading one under registration in Europe.
Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is
listed on Nasdaq Stockholm under the ticker XBRANE.For more
information, visit www.xbrane.com 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,
relating to the potential benefits and results that may be achieved
through Biogen’s proposed agreement with Xbrane Biopharma AB; the
anticipated completion and timing of the proposed transaction; the
potential benefits, safety and efficacy of Xcimzane™; risks and
uncertainties associated with drug development and
commercialization; the potential of Biogen’s commercial business
and pipeline programs; Biogen’s strategy and plans; and potential
cost healthcare savings related to biosimilars. 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, risks that the
proposed transaction will not be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed transaction can be
achieved; risks of unexpected costs or delays or other unexpected
hurdles; uncertainty of success in the development and potential
commercialization of Xcimzane™, which may be impacted by, among
other things, unexpected concerns that may arise from additional
data or analysis, the occurrence of adverse safety events, failure
to obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; risks of legal actions, regulatory
scrutiny or other challenges to biosimilars; the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
business, results of operations and financial condition; the risks
of doing business internationally, including currency exchange rate
fluctuations; product liability claims; and third party
collaboration risks. The foregoing sets forth many, but not all, of
the factors that could cause actual results to differ from Biogen’s
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in Biogen’s most recent annual or quarterly report and
in other reports Biogen has filed with the U.S. Securities and
Exchange Commission. These statements are based on Biogen’s current
beliefs and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
Xbrane Cautionary StatementThis news release
contains forward-looking statements, relating to the potential
benefits and results that may be achieved through Xbrane’s proposed
agreement with Biogen; the anticipated completion and timing of the
proposed transaction; the potential benefits, safety and efficacy
of Xcimzane; risks and uncertainties associated with drug
development and commercialization; the potential of Xbrane’s
commercial business and pipeline programs; Xbrane’s strategy and
plans; and potential cost healthcare savings related to
biosimilars. 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, risks that the
proposed transaction will not be completed in a timely manner or at
all; the possibility that certain closing conditions to the
proposed transaction will not be satisfied; uncertainty as to
whether the anticipated benefits of the proposed transaction can be
achieved; risks of unexpected costs or delays or other unexpected
hurdles; uncertainty of success in the development and potential
commercialization of Xcimzane™, which may be impacted by, among
other things, unexpected concerns that may arise from additional
data or analysis, the occurrence of adverse safety events, failure
to obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; risks of legal actions, regulatory
scrutiny or other challenges to biosimilars; the direct and
indirect impacts of the ongoing COVID-19 pandemic on Xbrane’s
business, results of operations and financial condition; the risks
of doing business internationally, including currency exchange rate
fluctuations; product liability claims; and third party
collaboration risks. The foregoing sets forth many, but not all, of
the factors that could cause actual results to differ from Xbrane’s
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in Xbrane’s most recent annual or quarterly report and
in other reports Xbrane has filed. These statements are based on
Xbrane’s current beliefs and expectations and speak only as of the
date of this news release. Xbrane does not undertake any obligation
to publicly update any forward-looking statements, whether because
of new information, future developments or otherwise.
References1 CIMZIA® is a registered trademark of UCB2 Company
reported
saleshttps://reports.ucb.com/FbContent.ashx/pub_1000/downloads/v210225063440/UCB%20ANNUAL%20REPORT%202020_v6.4.5.pdf
MEDIA
CONTACT:BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.comXbrane Biopharma
ABMartin Åmark, CEO+46 76 309 37
77martin.amark@xbrane.com |
INVESTOR
CONTACT:BiogenMike Hencke+1 781 464
2442IR@biogen.com Xbrane Biopharma
ABAnette Lindqvist, CFO/IR+46 76 325 60
90anette.lindqvist@xbrane.com |
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