INCHEON, South Korea and
NEW YORK, April 25, 2021 /PRNewswire/ -- Samsung
Biologics (KRX: 207940.KS), the world's leading contract
development and manufacturing organization and TG Therapeutics
(NASDAQ: TGTX), today announced an expansion of a large-scale
contract manufacturing deal for the supply of TG Therapeutics'
ublituximab, an investigational anti-CD20 monoclonal antibody. TG
Therapeutics has completed a rolling submission of a Biologics
License Application (BLA) to the U.S. Food and Drug
Administration (FDA) requesting approval of ublituximab, in
combination with UKONIQ™ (umbralisib), TG
Therapeutics' oral once-daily inhibitor of PI3K-delta and
CK1-epsilon, as a treatment for patients with CLL, based primarily
on the positive results from the UNITY-CLL Phase 3 trial.
Ublituximab was also the subject of two successful Phase 3 trials
in patients with relapsing forms of multiple sclerosis (RMS) and a
BLA is currently being prepared for this indication.
"We are very glad to be able to flexibly accommodate our
client's expanded needs through our facilities," John Rim, CEO of Samsung Biologics, commented.
Rim added, "By supporting TG Therapeutics in this partnership, we
are contributing to bringing needed treatments to patients around
the world and getting a step closer to our vision of bringing about
a better life for humanity."
Michael S. Weiss, Executive
Chairman and CEO of TG Therapeutics, stated, "Samsung is the global
leader in biologics manufacturing and we are happy to have them as
our partner as we look forward to the potential commercialization
of ublituximab across both oncology and autoimmune indications.
With the recent positive ULTIMATE I and II MS Phase 3 studies, we
re-evaluated our supply needs and were very pleased we were able to
secure the long-term capacity we believe we will need to meet the
potential global demand for ublituximab. This is an important next
step in our long-standing relationship with Samsung."
In order to support all its current and potential clients around
the world, Samsung Biologics is currently building its fourth and
largest biomanufacturing facility in Incheon, Korea. Upon
completion of the said plant in 2023, Samsung Biologics will hold
620,000 liters of biomanufacturing capacity, or approximately a
quarter of the entire bio-CMO capacity globally. The company
provides contract manufacturing, contract development, and testing
services all from a single location, offering end-to-end services
for its clients.
ABOUT UBLITUXIMAB
Ublituximab is an investigational
glycoengineered monoclonal antibody that targets a unique epitope
on CD20-expressing B-cells. When ublituximab binds to the B-cell it
triggers a series of immunological reactions, including
antibody-dependent cellular cytotoxicity (ADCC) and complement
dependent cytotoxicity (CDC), leading to destruction of the cell.
Additionally, ublituximab is uniquely designed, to lack certain
sugar molecules normally expressed on the antibody. Removal of
these sugar molecules, a process called glycoengineering, has been
shown to enhance the potency of ublituximab, especially the ADCC
activity. Targeting CD20 using monoclonal antibodies has proven to
be an important therapeutic approach for the management of B-cell
malignancies and autoimmune disorders, both diseases driven by the
abnormal growth or function of B-cells.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a
fully-integrated, commercial stage biopharmaceutical company
focused on the acquisition, development and commercialization of
novel treatments for B-cell malignancies and autoimmune diseases.
In addition to an active research pipeline including five
investigational medicines across these therapeutic areas, TG has
received accelerated approval from the U.S. FDA for
UKONIQ™ (umbralisib), for the treatment of adult patients with
relapsed/refractory marginal zone lymphoma who have received at
least one prior anti-CD20-based regimen and relapsed/refractory
follicular lymphoma who have received at least three prior lines of
systemic therapies. Currently, the Company has two programs in
Phase 3 development for the treatment of patients with relapsing
forms of multiple sclerosis (RMS) and patients with chronic
lymphocytic leukemia (CLL) and several investigational medicines in
Phase 1 clinical development. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and LinkedIn.
UKONIQ™ is a trademark of TG Therapeutics, Inc.
About Samsung Biologics Co., Ltd.
Samsung Biologics
(KRX: 207940.KS) is a fully integrated CDMO offering
state-of-the-art contract development, manufacturing, and
laboratory testing services. With proven regulatory approvals, the
largest capacity, and the fastest throughput, Samsung Biologics is
an award-winning partner of choice and is uniquely able to support
the development and manufacturing of biologics products at every
stage of the process while meeting the evolving needs of
biopharmaceutical companies worldwide. For more information, visit
www.samsungbiologics.com.
Samsung Biologics Forward-looking Statement
Samsung
Biologics Forward-looking Statements This press release contains
certain statements that constitute forward-looking statements,
including statements that describe Samsung Biologics' objectives,
plans or goals. All such forward-looking statements, and the
assumptions on which they are based, are subject to certain risks
and uncertainties that could cause actual results to differ
materially from those contemplated by the relevant forward-looking
statements. There can be no assurance that the results and events
contemplated by the forward-looking statements contained herein
will in fact occur. Except as required by law, Samsung Biologics
will not update any forward-looking statements to reflect material
developments that may occur after the date of this press
release.
TG Therapeutics, Inc. Cautionary Statement
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995, including statements relating to the development and
potential commercialization of ublituximab, the relationship with
Samsung, and the supply of ublituximab. In addition to the
risk factors identified from time to time in our reports filed with
the U.S. Securities and Exchange Commission, factors that could
cause our actual results to differ materially are the following:
the risk that ublituximab will not be approved by the FDA or any
other regulatory authority for CLL, RMS, or any other indication;
the risk that ublituximab will not be commercially successful if
approved; our ability to successfully and cost effectively complete
preclinical and clinical trials; the Company's reliance on third
parties for manufacturing, distribution and supply, and a range of
other support functions for its clinical and commercial products,
including ublituximab; the uncertainties inherent in research and
development; and the risk that the ongoing COVID-19 pandemic and
associated government control measures have an adverse impact on
our research and development plans or commercialization efforts.
Further discussion about these and other risks and uncertainties
can be found in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2020 and in our other filings with
the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available
at www.tgtherapeutics.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
TG THERAPEUTICS CONTACT INFORMATION:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
SAMSUNG BIOLOGICS CONTACT INFORMATION:
Media Relations:
Email: cair.kim@samsung.com
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SOURCE Samsung Biologics