TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the
issuance of three additional patents by the United States Patent
and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the
first and only anti-CD20 monoclonal antibody approved in the US for
patients with relapsing forms of multiple sclerosis (RMS) that can
be administered in a one-hour infusion following the starting dose.
The additional recently issued patents, US Patent Nos.
11,807,689; 11,814,439; and 11,884,740, leverage the unique
glycoprofile of ublituximab to extend patent protection covering
the composition of matter of ublituximab and methods of treatment
utilizing ublituximab into 2042.
Michael S. Weiss, Chairman and Chief Executive Officer of TG
Therapeutics, stated, “We are pleased to announce the issuance of
these additional patents for BRIUMVI which add to our existing
patent portfolio, and extend patent protection through 2042. Life
cycle management is of the utmost importance, and we believe these
additional patents will provide a long runway to continue to
explore the full potential of BRIUMVI, including expanding the
potential reach of BRIUMVI in multiple sclerosis as well as in
other autoimmune indications.”
BRIUMVI is currently approved and commercially available in the
US for patients with RMS, to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease, in adults. BRIUMVI has also been approved by the European
Commission (EC) and the Medicines and Healthcare Products
Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS
who have active disease defined by clinical or imaging features in
Europe and the United Kingdom, respectively, and is commercially
available in Germany.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection
for IVBRIUMVI is a novel monoclonal antibody that targets
a unique epitope on CD20-expressing B-cells. Targeting CD20 using
monoclonal antibodies has proven to be an important therapeutic
approach for the management of autoimmune disorders, such as RMS.
BRIUMVI is uniquely designed to lack certain sugar molecules
normally expressed on the antibody. Removal of these sugar
molecules, a process called glycoengineering, allows for efficient
B-cell depletion at low doses.
BRIUMVI is indicated in the US for the treatment of adults with
RMS, to include clinically isolated syndrome, relapsing-remitting
disease, and active secondary progressive disease and in the EU and
UK for the treatment of adult patients with RMS with active disease
defined by clinical or imaging features.
IMPORTANT SAFETY
INFORMATION Contraindications: BRIUMVI is
contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to
BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion
reactions, which can include pyrexia, chills, headache,
influenza-like illness, tachycardia, nausea, throat irritation,
erythema, and an anaphylactic reaction. In MS clinical trials, the
incidence of infusion reactions in BRIUMVI-treated patients who
received infusion reaction-limiting premedication prior to each
infusion was 48%, with the highest incidence within 24 hours of the
first infusion. 0.6% of BRIUMVI-treated patients experienced
infusion reactions that were serious, some requiring
hospitalization.
Observe treated patients for infusion reactions during the
infusion and for at least one hour after the completion of the
first two infusions unless infusion reaction and/or
hypersensitivity has been observed in association with the current
or any prior infusion. Inform patients that infusion reactions can
occur up to 24 hours after the infusion. Administer the recommended
pre-medication to reduce the frequency and severity of infusion
reactions. If life-threatening, stop the infusion immediately,
permanently discontinue BRIUMVI, and administer appropriate
supportive treatment. Less severe infusion reactions may involve
temporarily stopping the infusion, reducing the infusion rate,
and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal,
bacterial and viral infections have been reported in
BRIUMVI-treated patients. In MS clinical trials, the overall rate
of infections in BRIUMVI-treated patients was 56% compared to 54%
in teriflunomide-treated patients. The rate of serious infections
was 5% compared to 3% respectively. There were 3 infection-related
deaths in BRIUMVI-treated patients. The most common infections in
BRIUMVI-treated patients included upper respiratory tract infection
(45%) and urinary tract infection (10%). Delay BRIUMVI
administration in patients with an active infection until the
infection is resolved.
Consider the potential for increased immunosuppressive effects
when initiating BRIUMVI after immunosuppressive therapy or
initiating an immunosuppressive therapy after
BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV
reactivation occurred in an MS patient treated with BRIUMVI in
clinical trials. Fulminant hepatitis, hepatic failure, and death
caused by HBV reactivation have occurred in patients treated with
anti-CD20 antibodies. Perform HBV screening in all patients before
initiation of treatment with BRIUMVI. Do not start treatment with
BRIUMVI in patients with active HBV confirmed by positive results
for HBsAg and anti-HB tests. For patients who are negative for
surface antigen [HBsAg] and positive for HB core antibody [HBcAb+]
or are carriers of HBV [HBsAg+], consult a liver disease expert
before starting and during treatment.
Progressive Multifocal Leukoencephalopathy
(PML): Although no cases of PML have occurred in
BRIUMVI-treated MS patients, JCV infection resulting in PML has
been observed in patients treated with other anti-CD20 antibodies
and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate
diagnostic evaluation. Typical symptoms associated with PML are
diverse, progress over days to weeks, and include progressive
weakness on one side of the body or clumsiness of limbs,
disturbance of vision, and changes in thinking, memory, and
orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms;
monitoring for signs consistent with PML may be useful. Further
investigate suspicious findings to allow for an early diagnosis of
PML, if present. Following discontinuation of another MS medication
associated with PML, lower PML-related mortality and morbidity have
been reported in patients who were initially asymptomatic at
diagnosis compared to patients who had characteristic clinical
signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be
discontinued.
Vaccinations: Administer all immunizations
according to immunization guidelines: for live or live-attenuated
vaccines at least 4 weeks and, whenever possible at least 2 weeks
prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may
interfere with the effectiveness of non-live vaccines. The safety
of immunization with live or live-attenuated vaccines during or
following administration of BRIUMVI has not been studied.
Vaccination with live virus vaccines is not recommended during
treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with
BRIUMVI During Pregnancy: In infants of mothers exposed to
BRIUMVI during pregnancy, assess B-cell counts prior to
administration of live or live-attenuated vaccines as measured by
CD19+ B-cells. Depletion of B-cells in these infants may increase
the risks from live or live-attenuated vaccines. Inactivated or
non-live vaccines may be administered prior to B-cell recovery.
Assessment of vaccine immune responses, including consultation with
a qualified specialist, should be considered to determine whether a
protective immune response was mounted.
Fetal Risk: Based on data from animal studies,
BRIUMVI may cause fetal harm when administered to a pregnant woman.
Transient peripheral B-cell depletion and lymphocytopenia have been
reported in infants born to mothers exposed to other anti-CD20
B-cell depleting antibodies during pregnancy. A pregnancy test is
recommended in females of reproductive potential prior to each
infusion. Advise females of reproductive potential to use effective
contraception during BRIUMVI treatment and for 6 months after the
last dose.
Reduction in Immunoglobulins: As expected with
any B-cell depleting therapy, decreased immunoglobulin levels were
observed. Decrease in immunoglobulin M (IgM) was reported in 0.6%
of BRIUMVI-treated patients compared to none of the patients
treated with teriflunomide in RMS clinical trials. Monitor the
levels of quantitative serum immunoglobulins during treatment,
especially in patients with opportunistic or recurrent infections,
and after discontinuation of therapy until B-cell repletion.
Consider discontinuing BRIUMVI therapy if a patient with low
immunoglobulins develops a serious opportunistic infection or
recurrent infections, or if prolonged hypogammaglobulinemia
requires treatment with intravenous immunoglobulins.
Most Common Adverse Reactions: The most common
adverse reactions in RMS trials (incidence of at least 10%) were
infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with
questions about BRIUMVI should visit www.briumvi.com.
The full SmPC approved in the EU for BRIUMVI can be found here
Briumvi | European Medicines Agency (europa.eu).
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG
Therapeutics to support U.S. patients through their treatment
journey in a way that works best for them. More information about
the BRIUMVI Patient Support program can be accessed at
www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS Relapsing
multiple sclerosis (RMS) is a chronic demyelinating disease of the
central nervous system (CNS) and includes people with
relapsing-remitting multiple sclerosis (RRMS) and people with
secondary progressive multiple sclerosis (SPMS) who continue to
experience relapses. RRMS is the most common form of multiple
sclerosis (MS) and is characterized by episodes of new or worsening
signs or symptoms (relapses) followed by periods of recovery. It is
estimated that nearly 1 million people are living with MS in the
United States and approximately 85% are initially diagnosed with
RRMS.1,2 The majority of people who are diagnosed with RRMS will
eventually transition to SPMS, in which they experience steadily
worsening disability over time. Worldwide, more than 2.3 million
people have a diagnosis of MS.1
ABOUT TG THERAPEUTICSTG Therapeutics is a fully
integrated, commercial stage, biopharmaceutical company focused on
the acquisition, development and commercialization of novel
treatments for B-cell diseases. In addition to a research pipeline
including several investigational medicines, TG has received
approval from the U.S. FDA for BRIUMVI® (ublituximab-xiiy), for the
treatment of adult patients with relapsing forms of multiple
sclerosis, to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease, as well as approval by the European Commission (EC) and
the Medicines and Healthcare Products Regulatory Agency (MHRA)
BRIUMVI to treat adult patients with RMS who have active disease
defined by clinical or imaging features in Europe and the United
Kingdom, respectively. For more information, visit
www.tgtherapeutics.com, and follow us on X (formerly Twitter)
@TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary StatementThis press release contains
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release. In addition to the risk factors identified from
time to time in our reports filed with the U.S. Securities and
Exchange Commission (SEC), factors that could cause our actual
results to differ materially include the below.
Such forward looking statements include but are not limited to
statements regarding expectations for the continued success of
BRIUMVI® (ublituximab-xiiy) for RMS in the US markets, the success
of our partner’s commercial launch of BRIUMVI for RMS in the EU and
other ex-US markets; anticipated healthcare professional and
patient acceptance and use of BRIUMVI for either the indication of
use approved by the FDA or those approved by the EC; statements
regarding the results of the ULTIMATE I & II Phase 3 studies;
statements regarding the Company’s beliefs about the benefits that
BRIUMVI could provide to RMS patients; and statements regarding the
Company’s expectations regarding future sales of BRIUMVI and the
outcome of continuing studies, potential future approvals, and
sales of BRIUMVI, the risk that any or all of the newly issued
patents could be challenged resulting in loss of exclusivity
earlier than 2042, the risk that the newly issued patents could
result in litigation which could result in significant expense to
the Company and if we were to lose or settle such litigation that
could result in loss of exclusivity earlier than 2042, and the risk
that the newly issued patents do not prevent entry to market of a
biosimilar.
Additional factors that could cause our actual results to differ
materially include the following: the Company’s ability to
establish and maintain a commercial infrastructure for BRIUMVI, and
to successfully or in the timeframe projected, market and sell
BRIUMVI in the US or the EU; the risk that early trends in
prescriptions are not maintained or that prescriptions are not
filled; the failure to obtain and maintain payor coverage; the risk
that early healthcare provider interest in BRIUMVI will not be
sustained; the risk that momentum in US sales for BRIUMVI will not
build or remain consistent; the risk that the US BRIUMVI launch
does not continue to exceed expectations; the risk that the EU
BRIUMVI launch does not meet or exceed expectations; the failure to
obtain and maintain requisite regulatory approvals, including the
risk that the Company fails to satisfy post-approval regulatory
requirements, the potential for variation from the Company’s
projections and estimates about the potential market for BRIUMVI
due to a number of factors, including, further limitations that
regulators may impose on the required labeling for BRIUMVI (such as
modifications, resulting from safety signals that arise in the
post-marketing setting or in the long-term extension study from the
ULTIMATE I and II clinical trials); the Company’s ability to meet
post-approval compliance obligations (on topics including but not
limited to product quality, product distribution and supply chain,
pharmacovigilance, and sales and marketing); the Company’s reliance
on third parties for manufacturing, distribution and supply, and
other support functions for our clinical and commercial products,
including BRIUMVI, and the ability of the Company and its
manufacturers and suppliers to produce and deliver BRIUMVI to meet
the market demand for BRIUMVI; potential regulatory challenges to
the Company’s plans to seek marketing approval for the product in
jurisdictions outside of the U.S. and the EU; the
uncertainties inherent in research and development; the risk that
any individual patient’s clinical experience in the post-marketing
setting, or the aggregate patient experience in the post-marketing
setting, may differ from that demonstrated in controlled clinical
trials such as ULTIMATE I and II; the possible occurrence of any
event, change or other circumstance or condition that could give
rise to the termination of the commercialization agreement or other
material agreements; the potential for litigation relating to the
commercialization of BRIUMVI; potential adverse reactions or
changes to business relationships resulting from the announcement
or completion of the commercialization agreement or any other
proposed transaction; the risk that the Company will not receive
some or all of the potential sales-based milestone payments owed;
and general political, economic and business conditions that could
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, 2022 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
NEURAXPHARM CONTACT INFORMATION: Nick Bastin / Charlotte
Hepburne-Scott / Zoe Bolt / Elena
Bates Tel: +44
(0)203 882
9621 Neuraxpharm@optimumcomms.com
1. MS Prevalence. National Multiple
Sclerosis Society
website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence.
Accessed October 26, 2020. 2. Multiple
Sclerosis International Federation, 2013
via Datamonitor p. 236.
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