TG Therapeutics, Inc. (NASDAQ: TGTX) (TG Therapeutics) today
announced that its ex-US partner, Neuraxpharm Group (Neuraxpharm),
a leading European specialty pharmaceutical company focused on the
treatment of central nervous system (CNS) disorders, launched
BRIUMVI® (ublituximab-xiiy) in Europe, for the treatment of adults
patients with relapsing forms of multiple sclerosis (RMS), who have
active disease defined by clinical or imaging features. The launch
commenced in Germany, with additional launches throughout Europe to
follow. In accordance with the ex-US commercialization agreement,
TG Therapeutics will receive a milestone payment of $12.5 million
for the first launch of BRIUMVI in a European country.
Michael S. Weiss, Chairman and Chief Executive Officer of TG
Therapeutics, stated, “We want to congratulate our partner,
Neuraxpharm, on the official launch of BRIUMVI in Europe. This is
an exciting day for patients in Europe with RMS, and we look
forward to sharing additional updates as the European launch
progresses.” BRIUMVI is currently approved and commercially
available in the US for patients with RMS, including 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) to treat adult
patients with RMS who have active disease defined by clinical or
imaging features in the European Union (EU) and the United Kingdom
(UK), respectively. TG Therapeutics entered into an agreement with
Neuraxpharm (the commercialization agreement) for the ex-US
commercialization of BRIUMVI® in August 2023.
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, including clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease and in the European Union (EU) for the
treatment of adult patients with RMS with active disease defined by
clinical or imaging features.
Highlights from the EU Label for BRIUMVI®In the
EU, BRIUMVI is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis (RMS) with active disease
defined by clinical or imaging features.
CONTRAINDICATIONS:
- Hypersensitivity to the active substance or to any of the
excipients
- Severe active infection
- Patients in a severely immunocompromised state
- Known active malignancies
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Traceability: The name and the
batch number of the administered product should be clearly
recorded.
Infusion-related reactions
(IRRs): Symptoms of IRR may include pyrexia, chills,
headache, tachycardia, nausea, abdominal pain, throat irritation,
erythema, and anaphylactic reaction.
Patients should premedicate with a
corticosteroid and an antihistamine to reduce the frequency and
severity of IRRs. The addition of an antipyretic (e.g.,
paracetamol) may also be considered. Patients treated with
ublituximab should be observed during infusions. Patients should be
monitored for at least one hour after the completion of the first
two infusions. Subsequent infusions do not require monitoring
post-infusion unless IRR and/or hypersensitivity has been observed.
Physicians should inform patients that IRRs can occur up to 24
hours after the infusion.
Infections: Administration must be delayed in
patients with an active infection until the infection is
resolved.
It is recommended to verify the patient’s immune
status before dosing since severely immunocompromised patients
(e.g., significant neutropenia or lymphopenia) should not be
treated. Ublituximab has the potential for serious, sometimes
life-threatening or fatal, infections. Most of the serious
infections that occurred in controlled clinical trials in RMS
resolved. There were 3 infection-related deaths that occurred, all
in patients treated with ublituximab; the infections leading to
death were post-measles encephalitis, pneumonia, and postoperative
salpingitis following an ectopic pregnancy.
Progressive Multifocal Leukoencephalopathy
(PML): John Cunningham virus (JCV) infection resulting in PML has
been observed very rarely in patients treated with anti-CD20
antibodies and mostly associated with risk factors (e.g., patient
population, lymphopenia, advanced age, polytherapy with
immunosuppressants). Physicians should be vigilant for the early
signs and symptoms of PML, which can include any new onset, or
worsening of neurological signs or symptoms, as these can be
similar to MS disease.
If PML is suspected, dosing with ublituximab
must be withheld. Evaluation including Magnetic Resonance Imaging
(MRI) scan preferably with contrast (compared with pre-treatment
MRI), confirmatory cerebro-spinal fluid (CSF) testing for JCV
Deoxyribonucleic acid (DNA) and repeat neurological assessments,
should be considered. If PML is confirmed, treatment must be
discontinued permanently.
Hepatitis B Virus (HBV) Reactivation: HBV
reactivation, in some cases resulting in fulminant hepatitis,
hepatic failure and death, has been observed in patients treated
with anti-CD20 antibodies.
HBV screening should be performed in all
patients before initiation of treatment as per local guidelines.
Patients with active HBV (i.e., an active infection confirmed by
positive results for HBsAg and anti HB testing) should not be
treated with ublituximab. Patients with positive serology (i.e.,
negative for HBsAg and positive for HB core antibody (HBcAb +) or
who are carriers of HBV (positive for surface antigen, HBsAg+)
should consult liver disease experts before starting the treatment
and should be monitored and managed following local medical
standards to prevent hepatitis B reactivation.
Vaccinations: The safety of
immunisation with live or live-attenuated vaccines, during or
following therapy has not been studied and vaccination with
live-attenuated or live vaccines is not recommended during
treatment and not until B-cell repletion. All immunisations should
be administered according to immunisation guidelines at least 4
weeks prior to treatment initiation for live or live-attenuated
vaccines and, whenever possible, at least 2 weeks prior to
treatment initiation for inactivated vaccines.
Vaccination of infants born to mothers treated
with ublituximab during pregnancy: In infants of mothers treated
with ublituximab during pregnancy, live or live-attenuated vaccines
should not be administered before the recovery of B-cell counts has
been confirmed. Depletion of B cells in these infants may increase
the risks associated with live or live-attenuated vaccines.
Measuring CD19-positive B-cell levels, in neonates and infants,
prior to vaccination is recommended.
Inactivated vaccines may be administered as
indicated prior to recovery from B-cell depletion. However,
assessment of vaccine immune responses, including consultation with
a qualified specialist, should be considered to determine whether a
protective immune response was mounted. The safety and timing of
vaccination should be discussed with the infant’s physician.
Sodium: This medicinal product
contains less than 1 mmol sodium (23 mg) per dose, that is to say
essentially ‘sodium-free’.
UNDESIRABLE EFFECTS
Summary of the safety profile: The most
important and frequently reported adverse reactions are IRRs
(45.3%) and infections (55.8%).
The full Summary of Product Characteristics approved in the EU
can be consulted in: Briumvi | European Medicines Agency
(europa.eu).
Please visit www.briumvi.com for U.S. Important Safety
Information for BRIUMVI or please see U.S. Full Prescribing
Information.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.1ABOUT 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 Therapeutics has received
approval from the U.S. Food and Drug Administration (FDA) for
BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients
with relapsing forms of multiple sclerosis (RMS), including
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 the European Union (EU) and the United Kingdom (UK),
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 continuing success of BRIUMVI® (ublituximab-xiiy) for RMS
in the US markets, the timing and success of our commercial launch
and availability 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, and the related impact on the potential sales-based
milestone payments under the commercialization agreement, and the
Company’s and Neuraxpharm’s plans and expectations for the launch
and impact of BRIUMVI in the EU.
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
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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