Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for
Tocilizumab Biosimilar Candidate at the Annual European Congress of
Rheumatology (EULAR 2022)
Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd.
(688177.SH) today presented positive Phase 3 data for BIIB800
(BAT1806), a biosimilar candidate referencing
ACTEMRA®/ROACTEMRA® (tocilizumab), anti-interleukin-6 receptor
monoclonal antibody, at the Annual European Congress of
Rheumatology (EULAR 2022).
Data from the Phase 3 comparative clinical trial demonstrated
that the investigational biosimilar candidate BIIB800 has
equivalent efficacy and comparable safety and immunogenicity
profile to the reference tocilizumab product. The double-blind
52-week Phase 3 study randomized 621 patients with moderate to
severe rheumatoid arthritis to receive either BIIB800 or the
reference tocilizumab administered intravenously every 4 weeks at a
dose of 8 mg/kg for the first 24 weeks.
The primary endpoints were ACR20* response at week 12 and week
24. The ACR20 response rates in the BIIB800 group and the reference
tocilizumab group were 68.97% vs. 64.82% at week 12 and 69.89% vs.
67.94% at week 24. The estimated difference between the two groups
were within the pre-defined equivalence margins (4.15% (95% CI -
3.63 to 11.93) at week 12 and 1.94% (90% CI -4.04 to 7.92; 95% CI
-5.18 to 9.07) at week 24. The treatment groups were comparable in
terms of serum trough tocilizumab levels, incidence of treatment
emergent adverse events and anti-drug antibody positivity and hence
demonstrated comparable pharmacokinetics, safety and
immunogenicity.
“At Biogen, we are advancing development of pipeline of
biosimilar candidates like BIIB800 with the goal of optimizing the
management of chronic immune mediated inflammatory diseases and
helping more patients and healthcare systems across the world to
benefit from biologics,” said Mourad Farouk Rezk, MD, Head of
Global Medical and Development Biosimilars at Biogen. “Biogen is
committed to the scientific progress in the treatment of various
immunologic conditions that accelerate our ability to tackle these
complex diseases.”
“Bio-Thera is proud to have the Phase 3 data for BIIB800
(BAT1806) presented to doctors, researchers, and patients at the
EULAR conference. These results highlight the expertise and
commitment of Bio-Thera to develop the highest quality biosimilars
of important therapeutic products to expand patient access around
the globe,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions.
The abstract is available online at the website of EULAR 2022
which has been held both virtually through the Congress platform
and on-site in Copenhagen, Denmark between June 1-4, 2022.
ACTEMRA®/ ROACTEMRA® is indicated for moderate to severe
rheumatoid arthritis in adults as well as juvenile idiopathic
polyarthritis, systemic juvenile idiopathic arthritis, giant cell
arteritis, chimeric antigen receptor (CAR) T cell-induced cytokine
release syndrome, systemic sclerosis-associated interstitial lung
disease (approved by FDA) and coronavirus disease 2019 (COVID-19)
(under emergency use authorization by FDA), and severe COVID-19
(approved by EMA).
On April 8th, 2021, Biogen and Bio-Thera Solutions, Ltd. entered
into a commercialization and license agreement to develop,
manufacture and commercialize BIIB800 (BAT1806). Biogen has
exclusive regulatory, manufacturing and commercial rights to
BIIB800 in all countries excluding China (including Hong Kong,
Macau and Taiwan).
About the BIIB800 Phase 3 Trial
The BIIB800 clinical trial was a global, randomized,
multicenter, double-blind, parallel-group, Phase 3 active-control
study designed to evaluate the efficacy, safety, PK and
immunogenicity of BIIB800 compared to ACTEMRA®/ROACTEMRA® in 621
patients with moderate to severe rheumatoid arthritis with
inadequate response to methotrexate. Out of the 621 total patients
enrolled in the Phase 3 Trial, 253 (40.7%) patients were from China
and 368 (59.3%) patients were from Europe. More information
regarding the BIIB800 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
About Biogen
As 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
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
our website at www.biogen.com. To learn more, please visit
www.biogen.com and follow Biogen on social media
– Twitter, LinkedIn, Facebook, YouTube.
About Bio-Thera Solutions, Ltd.
Bio-Thera Solutions, Ltd., a leading global biotechnology
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. A
leader in next generation antibody discovery and engineering, the
company has advanced six candidates into late-stage clinical trials
and has two approved products, QLETLI® and POBEVCY® in China. In
addition, the company has multiple promising candidates in early
clinical trials and IND-enabling studies, focusing on
immuno-oncology, ADC targeted therapies, autoimmune diseases, and
other severe and emerging unmet medical needs. 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:
*ACR20 is a 20% improvement in the American College of
Rheumatology response criteria
- ACTEMRA®/ROACTEMRA® is a registered trademark of
Genentech, Inc.
MEDIA AND INVESTOR CONTACT -
BIOGEN:
For Investors: Mike Hencke, +1 781 464-2442, IR@biogen.com
For Media: Ashleigh Koss, + 1 908 205 2572,
public.affairs@biogen.com
MEDIA CONTACT - BIO-THERA SOLUTIONS:
Bert E. Thomas IV
Bio-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