Bio-Thera Solutions, Ltd. (688177.SH) and Hikma Pharmaceuticals
PLC (LSE: HIK) today announced that they have entered into a
commercialization and license agreement to commercialize BAT2206, a
monoclonal antibody that is a proposed biosimilar referencing
Stelara® (ustekinumab), in the United States (US). BAT2206 is
currently in a global Phase III clinical trial.
Under the agreement, Bio-Thera will maintain responsibility for
development, manufacturing, and supply of BAT2206. Hikma will have
exclusive rights to commercialize the product in the US. The
agreement also provides Hikma with a first-right-to-negotiate to
add Europe (excluding CIS countries). Bio-Thera is eligible for an
upfront payment of $20 million as well as further development and
commercial milestones of up to $130 million.
“Partnering with Hikma to commercialize BAT2206, our ustekinumab
biosimilar, further validates the high quality of the work
performed at Bio-Thera,” said Dr. Shengfeng Li, CEO of Bio-Thera
Solutions. “We are proud to expand our network of partners to
include another great company like Hikma.”
“This partnership provides us with a unique opportunity to enter
the biosimilar market in the US, building on our position as a
leading generic manufacturer in the US,” said Siggi Olafsson, Chief
Executive Officer of Hikma. “Tapping into the growth of the
biosimilar market in the US has been an area of focus for Hikma.
Our established commercial presence in the US market and
Bio-Thera’s strong technical capabilities for the development and
manufacturing of biological products are highly complementary and
we are excited by the potential this partnership offers.”
About BAT2206 (ustekinumab)
BAT2206 is a proposed biosimilar to Jansen’s Stelara® which is a
human monoclonal antibody that inhibits the bioactivity of human
IL-12 and IL-23 by preventing shared p40 from binding to the
IL-12Rβ1 receptor protein expressed on the surface of immune cells.
IL-12 and IL-23 are involved in inflammatory and immune responses,
such as natural killer cell activation and CD4+ T-cell
differentiation and activation. IL-12 and IL-23 have been
implicated as important contributors to the chronic inflammation
that is a hallmark of Crohn's disease and ulcerative colitis, among
many other autoimmune diseases. Stelara® is currently approved for
the treatment of active psoriatic arthritis (PsA) in adults, alone
or in combination with MTX, the treatment of patients 6 years or
older with moderate to severe plaque psoriasis (Ps) who are
candidates for phototherapy or systemic therapy, the treatment of
moderately to severely active Crohn’s disease (CD) in adults, and
the treatment of moderately to severely active ulcerative colitis
(UC) in adults.
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 six 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 stage clinical or entering
clinical studies, including differentiated and innovative
anti-OX40, anti-TIGIT, and anti-PD-L1/CD47 bispecific antibodies.
For more information, please visit www.bio-thera.com/en/ or follow
us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable
S&P and BBB-/stable Fitch) Hikma helps put better health within
reach every day for millions of people around the world. For more
than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we are a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform
cutting-edge science into innovative solutions that transform
people's lives. We're committed to our customers, and the people
they care for, and by thinking creatively and acting practically,
we provide them with a broad range of branded and non-branded
generic medicines. Together, our 8,600 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner, and through our venture capital arm, are
helping bring innovative health technologies to people around the
world. For more information, please visit: www.hikma.com
Bio-Thera Solutions Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain forward-looking statements
relating to BAT2206 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.
1 Stelara® is a registered trademark of Johnson & Johnson
Corporation 2 QLETLI® is a registered trademark of Bio-Thera
Solutions, Ltd. 3 格乐立® is a registered trademark of Bio-Thera
Solutions, Ltd.
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version on businesswire.com: https://www.businesswire.com/news/home/20210827005059/en/
Enquiries Bio-Thera Solutions
Bert E. Thomas IV +1 410 627 1734 (mobile) Senior Vice
President, Business Development bethomas@bio-thera.com
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776 477050 EVP,
Strategic Planning and Global Affairs uk-investors@hikma.uk.com
Steve Weiss +1 732 720 2830/ +1 732 788 8279 David Belian +1 732
720 2814/+1 848 254 4875 US Communications and Public Affairs
uscommunications@hikma.com
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