Biogen and Bio-Thera Announce Positive Results From Phase 3 Study
of BAT1806, a Proposed Biosimilar Referencing Actemra®
(Tocilizumab)
Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd.
(688177.SH) today announced results from the Phase 3 study of
BAT1806, a proposed biosimilar referencing ACTEMRA®/RoACTEMRA®
(tocilizumab). The study met its primary endpoints, demonstrating
equivalence to the reference medicine in patients with moderate to
severe rheumatoid arthritis (RA) inadequately controlled by
methotrexate therapy. The primary endpoint in the study was the
American College of Rheumatology 20 percent response criteria
(ACR20).
ACTEMRA/RoACTEMRA’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. Biosimilars are products
that demonstrate similar efficacy and safety to the originator’s
reference product, with the advantage that they can be more
affordable for patients and healthcare systems. In 2020 global
sales of ACTEMRA were 2.8 billion CHF. Biogen has exclusive
regulatory, manufacturing and commercial rights to BAT1806 in all
countries excluding China (including Hong Kong, Macau and
Taiwan).
“We are excited about these results and believe BAT1806
demonstrates equivalence in efficacy and pharmacokinetics as well
as a comparable safety and immunogenicity profile to the reference
product,” said Ian Henshaw, head of global biosimilars at Biogen.
“Biosimilars have the potential to generate cost savings,
healthcare sustainability and, if approved, BAT1806 would enable us
to bring an additional therapeutic option to patients.”
“We are pleased to report on our third proposed biosimilar with
positive Phase 3 study results. These results demonstrate the
potential of our proposed tocilizumab biosimilar to be a safe and
effective treatment,” said Shengfeng Li, Ph.D., chief executive
officer at Bio-Thera Solutions. “Bio-Thera is committed to
increasing patient access to innovative medicines through the
development of high-quality biosimilars.”
Biogen and Bio-Thera announced a commercialization and license
agreement in April 2021 to develop, manufacture and commercialize
BAT1806. As satisfactory results were met, Biogen will make a
payment of $30 million to Bio-Thera Solutions. 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.
About Biosimilars
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 to healthcare systems. 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 BAT1806 Phase 3 Trial Design
The BAT1806 clinical trial was a global, randomized,
multicenter, double-blind, parallel-group, Phase 3 active-control
study designed to evaluate the safety, efficacy, immunogenicity and
PK of BAT1806 compared to ACTEMRA®/RoACTEMRA® in 621 patients with
moderate to severe rheumatoid arthritis with inadequate response to
methotrexate. More information regarding the BAT1806 Phase 3
clinical trial, including inclusion and exclusion criteria and
primary and secondary outcome measures, can be found here:
https://clinicaltrials.gov/ct2/show/study/NCT03830203
Results of the study will be presented at a future medical
meeting or summarized in publication.
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, safety and efficacy of BAT1806; the potential
clinical effects of BAT1806; results from the Phase 3 study of
BAT1806; data presentations for BAT1806; potential regulatory
discussions, submissions and approvals and the timing thereof; the
anticipated benefits and potential of Biogen’s agreement with
Bio-Thera Solutions; 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, actual timing and
content of submissions to and decisions made by the regulatory
authorities regarding BAT1806; regulatory submissions may take
longer or be more difficult to complete than expected; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of Biogen’s
drug candidates, including BAT1806; 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 protect and enforce data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; uncertainty as to
whether the anticipated benefits of the Biogen’s agreement with
Bio-Thera Solutions can be achieved; 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: |
Natacha Gassenbach |
Mike Hencke |
Biogen Inc. |
Biogen Inc. |
Tel: (781) 464-3260 |
Tel: (781) 464-2442 |
BIO-THERA SOLUTIONS MEDIA CONTACT:Bert E. Thomas IVBio-Thera
Solutions, Ltd.Tel: (410) 627-1734
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024