GUANGZHOU, China --- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America.
BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-a), a pro-inflammatory molecule. Binding of golimumab to TNF- results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD.
“Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506”, said Dr. Shengfeng Li, CEO of Bio-Thera. “This partnership will expand Bio-Thera’s efforts to bring more immunology biosimilars to patients in USA.”
“Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy,” said Chrys Kokino, U.S. President of Accord. “We’re investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera’s global experience makes them an excellent partner.”
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical
company in Guangzhou, China, is dedicated to researching and developing
novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye
diseases, and other severe unmet medical needs, as well as biosimilars for
existing, branded biologics to treat a range of cancer and autoimmune diseases.
As a leader in next generation antibody discovery and engineering, the company has
advanced multiple candidates into late-stage development, including four
approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection)
in China, and TOFIDENCE®/ BAT1806 and Avzivi® / Pobevcy® in the US, EU
and China. In addition, the company has more than 20 promising candidates
in clinical trials, focusing on immuno-oncology in the post-PD-1 era and
targeted therapies such as ADCs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).
About Intas Pharmaceuticals
Intas Pharmaceuticals is a pioneer in biosimilars, having developed and
launched one of the highest numbers of indigenous biosimilars in India.
Intas Pharmaceuticals has a rich history of making quality biosimilars
accessible to the masses. Being the most affordable treatment option, Intas'
products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab),
Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management
of their respective therapies. Eleftha is the latest testament to Intas'
Biosimilar for Billions philosophy, fulfilling its commitment to provide
quality cancer care to the masses. Intas' biosimilars are manufactured at Intas
Pharmaceuticals' state of the art European Union- Good Manufacturing Practices
(EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For
more information, visit us at www.intaspharma.com.
About Accord BioPharma, Inc.
Accord BioPharma, Inc., the U.S.
specialty division of Intas Pharmaceuticals, seeks to provide affordable,
accessible, patient-centric therapies in oncology, immunology, and critical
care. With a focus on improving the patient experience, Accord BioPharma goes
beyond the biology of medicine to see disease from the patients' perspective
and develop high-quality therapies that impact patients' lives. Accord
BioPharma believes in the ability of biosimilars to increase access to a number
of biologic medicines, that in the past may not have been considered for
patients due to their high costs. Accord BioPharma looks forward to providing
one of the deepest biosimilar portfolios in the industry. For more information,
visit AccordBioPharma.com.
Bio-Thera Cautionary Note Regarding
Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT2506,
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. 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.
1. Simponi® is a registered trademark of Johnson & Johnson
2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
3. TOFIDENCE® is a trademark of Biogen MA Inc.
4. Avzivi® is a registered trademark of Sandoz AG
5. POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.
6. BETAGRIN® is a registered trademark of
Bio-Thera Solutions, Ltd.
