TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been
awarded a national contract with the Department of Veterans Affairs
(VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent
listed on the VA National Formulary for Anti-CD20 Antibody
indications for patients with relapsing forms of multiple sclerosis
(RMS).
Michael S. Weiss, Chief Executive Officer and Chairman of TG
Therapeutics stated, “We are immensely proud to collaborate with
the National VA Health System in bringing BRIUMVI to Veterans
across the country afflicted with RMS at a significant discount. We
believe this contract signifies a vote of confidence in the value
that BRIUMVI brings to patients with RMS and are pleased that
Veterans with MS will now have access to the only anti-CD20 therapy
that offers a one-hour twice a year therapy, following the first
dose.”
The contract period includes the base year ordering period of
June 17, 2024 to June 16, 2025, as well as four one-year option
periods that may be exercised unilaterally by the U.S. Government.
Pursuant to the contract, BRIUMVI will be required for new patient
starts unless clinically contraindicated. While not required,
patients currently prescribed other agents in the anti-CD20 class
may be switched over to BRIUMVI at the discretion of their doctor.
The total award amount of the contract has a potential value of
$186,776,520. This potential value assumes all MS patients
estimated to be treated with anti-CD20 therapies by the VA
annually, are treated with BRIUMVI each year for a five-year period
at the contract price.
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 for the treatment of adults with relapsing
forms of multiple sclerosis (RMS), to include clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease.
A list of authorized specialty distributors can be found at
www.briumvi.com.
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 premedantigen [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.
ABOUT BRIUMVI PATIENT SUPPORTBRIUMVI 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 SCLEROSISRelapsing 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 U.S. Food and Drug Administration (FDA) approval for
BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients
with relapsing forms of multiple sclerosis (RMS), 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) for 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 commercial launch of
BRIUMVI® (ublituximab-xiiy) for RMS in the United States;
anticipated healthcare professional (HCP) and patient acceptance
and use of BRIUMVI for the approved indications; and the potential
impact of the contract awarded by the Department of Veterans
Affairs.
Additional factors that could cause our actual results to differ
materially include the following: the Company’s ability to continue
to maintain a commercial infrastructure for BRIUMVI, and to
successfully market and sell BRIUMVI; the failure to maintain the
contract with the VA; the risk that the VA does not exercise any or
all of the option year periods; the risk that the total potential
award amount from the contract with the VA is not realized due to a
high degree of expected variability in the assumptions that underly
the total contract amount, including but not limited to, the VA
does not exercise their option to continue the contract beyond year
one, the total number of estimated MS patients treated by the VA
with an anti-CD20 therapy each year is less than estimated, that
fewer than all patients new to anti-CD20 will go on BRIUMVI and
fewer than all the patients currently treated with an anti-CD20 at
the VA will be switched to BRIUMVI, and the projected vial count
per patient per year is less than assumed by the VA; the risk that
HCP or patient interest in BRIUMVI will not be sufficient; the risk
that the Company’s BRIUMVI U.S. net revenue targets will not be
achieved; 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 its 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; and general
political, economic and business conditions. 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,
2023 and in our other filings with the SEC.
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.
CONTACT:
Investor 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
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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