Samsung Biologics and TG Therapeutics Expand Collaboration for the Large Scale Manufacture of Ublituximab
April 26 2021 - 7:00AM
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 UBLITUXIMABUblituximab 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.
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 INFORMATIONInvestor
Relations:Email: ir@tgtxinc.comTelephone: 1.877.575.TGTX
(8489), Option 4
Media
Relations:Email: media@tgtxinc.comTelephone: 1.877.575.TGTX
(8489), Option 6
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