Biogen and Bio-Thera Solutions Announce Commercialization and
License Agreement for Proposed Biosimilar Currently in Phase 3 With
the Potential to Treat Moderate to Severe Rheumatoid Arthritis
Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd.
(688177.SH) today announced that they entered into a
commercialization and license agreement to develop, manufacture and
commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6
(IL-6) receptor monoclonal antibody that is a proposed biosimilar
referencing ACTEMRA®1 (tocilizumab).
ACTEMRA®’s primary indication is for moderate to severe
rheumatoid arthritis in adults as well as juvenile idiopathic
polyarthritis, systemic juvenile idiopathic arthritis, giant cell
arteritis and cytokine release syndrome. In 2020 global sales of
ACTEMRA® were 2.8 billion CHF.2 Biogen will gain exclusive
regulatory, manufacturing and commercial rights to BAT1806 in all
countries excluding China (including Hong Kong, Macau and Taiwan).
Biogen will expand its global biosimilars footprint with the
potential approval of BAT1806.
Biosimilars 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 offer 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.
“We are excited about this new transaction with Bio-Thera
Solutions, a leading commercial-stage biopharmaceutical company in
China, and how BAT1806 will augment our expanding portfolio of
biosimilars assets,” said Chirfi Guindo, Head of Global Product
Strategy and Commercialization at Biogen. “Biosimilars deliver
sustainable value for patients, physicians, healthcare systems and
society by expanding access to leading biologic therapies
worldwide.”
“Bio-Thera Solutions is pleased to work with Biogen, one of the
world’s first and leading global biotechnology companies, to
commercialize BAT1806, our tocilizumab biosimilar program in all
countries outside of China,” said Dr. Shengfeng Li, CEO of
Bio-Thera Solutions. “This agreement allows Bio-Thera Solutions and
Biogen to bring a potentially new biosimilar option to
patients.”
Under the terms of the agreement, Biogen will make an upfront
payment of $30 million to Bio-Thera Solutions, contingent upon
Bio-Thera Solutions’ Phase 3 for BAT1806 achieving satisfactory
results. Should certain commercial milestones be achieved,
Bio-Thera Solutions will be eligible to receive potential milestone
payments. Biogen will also pay Bio-Thera Solutions tiered
royalties.
Closing of the transaction is contingent upon completion of
review under antitrust laws, including the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976 in the U.S. The transaction is
expected to close in the second quarter of 2021.
About Biogen
At Biogen, our mission is clear: we are pioneers in
neuroscience. Biogen discovers, develops and delivers worldwide
innovative therapies for people living with serious neurological
and neurodegenerative 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, Kenneth Murray and Nobel Prize winners Walter Gilbert and
Phillip Sharp. Today Biogen has the leading portfolio of medicines
to treat multiple sclerosis, has introduced the first approved
treatment for spinal muscular atrophy, commercializes biosimilars
of advanced biologics and is focused on advancing research programs
in multiple sclerosis and neuroimmunology, Alzheimer’s disease and
dementia, neuromuscular disorders, movement disorders,
ophthalmology, neuropsychiatry, immunology, acute neurology and
neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please visit
www.biogen.com and follow us on social media –
Twitter, LinkedIn, Facebook, YouTube.
About Bio-Thera Solutions, Ltd.
Bio-Thera Solutions, Ltd., a leading commercial-stage
biopharmaceutical company in Guangzhou, China, is dedicated to
researching and developing novel therapeutics for the treatment of
cancer, autoimmune, cardiovascular diseases, and other serious
unmet medical needs, as well as biosimilars for existing, branded
biologics to treat a range of cancer and autoimmune diseases. As a
leader in the next generation antibody discovery and engineering,
the company has advanced five candidates into late-stage clinical
trials and one of which, QLETLI® (格乐立®), a biosimilar to
adalimumab, is available to patients in China. In addition, the
company has multiple candidates in early clinical trials and
IND-enabling studies, including differentiated and innovative
anti-OX40, anti-TIGIT antibodies. For more information, please
visit www.bio-thera.com/en/ or follow us on Twitter
(@bio_thera_sol) and wechat (Bio-Thera).
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 Bio-Thera Solutions; the
anticipated completion and timing of the proposed transaction; the
potential benefits, safety and efficacy of BAT1806; 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 BAT1806, 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.
Bio-Thera Solutions Cautionary Note Regarding
Forward-Looking Statements
This news release contains certain forward-looking statements
relating to BAT1806 or the product pipelines in general of
Bio-Thera Solutions. Readers are strongly cautioned that reliance
on any forward-looking statements involves known and unknown risks
and uncertainties. The forward-looking statements include, among
others, those containing “could,” “may,” “should,” “will,” “would,”
“anticipate,” “believe,” “plan,” “promising,” “potentially,” or
similar expressions. They reflect the company’s current views with
respect to future events that are based on what the company
believes are reasonable assumptions in view of information
currently available to Bio-Thera Solutions, and are not a guarantee
of future performance or developments. Actual results and events
may differ materially from information contained in the
forward-looking statements as a result of a number of factors,
including, but not limited to, risks and uncertainties inherent in
pharmaceutical research and development, such as the uncertainties
of pre-clinical and clinical studies, for example, the development
processes could be lengthy and in vitro or early, small scale
clinical trial results may not translate into desired results in
vivo or in large scale clinical studies. Other risks and
uncertainties include challenges in obtaining regulatory approvals,
manufacturing, marketing, competition, intellectual property,
product efficacy or safety, changes in global healthcare situation,
changes in the company’s financial conditions, and changes to
applicable laws and regulations, etc. Forward-looking statements
contained herein are made only as of the date of their initial
publication. Unless required by laws or regulations, Bio-Thera
Solutions undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, changes in the company’s views or otherwise.
References:
- ACTEMRA® is a registered trademark of Genentech, Inc.
- Company reported sales
BIOGEN MEDIA
CONTACT: |
BIOGEN
INVESTOR CONTACT: |
David Caouette |
Mike Hencke |
Biogen Inc. |
Biogen Inc. |
Tel: (781) 464-3260 |
Tel: (781) 464-2442 |
|
|
BIO-THERA SOLUTIONS MEDIA CONTACT: |
|
Bert E. Thomas IV |
|
Bio-Thera Solutions, Ltd. |
|
Tel: (410) 627-1734 |
|
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