TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) and Neuraxpharm Group
(Neuraxpharm), a leading European specialty pharmaceutical company
focused on the treatment of central nervous system (CNS) disorders,
today announced an agreement for the ex-US commercialization of
BRIUMVI® (ublituximab). BRIUMVI is the first and only anti-CD20
monoclonal antibody approved in the United States (US) and European
Union (EU) for adult patients with relapsing forms of multiple
sclerosis (RMS) that can be administered in a one-hour infusion,
twice a year, following the starting dose. Neuraxpharm is backed by
funds advised by the global private equity firm, Permira.
Michael S. Weiss, TG’s Chairman and Chief Executive Officer,
stated, “We are very excited to be partnering with Neuraxpharm to
launch BRIUMVI in Europe. Their neurology-focused approach, broad
European platform and entrepreneurial organization really resonated
with us as an attractive partner for BRIUMVI.” Mr. Weiss continued,
"From a deal perspective, the terms provided us many important
benefits, including an upfront payment further solidifying our
balance sheet, attractive economic terms providing meaningful
participation in the ex-US success of BRIUMVI, an experienced
neurology team ready to rapidly launch BRIUMVI, and the strategic
flexibility to buy back the commercial rights over the next two
years in the event of an acquisition of TG.”
Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm,
stated, “As the leading CNS Company in Europe with direct presence
in over 20 countries, we believe BRIUMVI is an ideal product to
bring within our portfolio, and its unique attributes support its
potential to become a leading treatment option for patients with
relapsing forms of MS. We are committed to the success of BRIUMVI,
due to the positive impact it can make on patients’ lives, and we
will be making BRIUMVI our highest priority, adding 100+ new MS
specialists to our already deep CNS commercial team. We look
forward to working with TG Therapeutics and launching BRIUMVI in
Europe within the next six months, building further on
Neuraxpharm’s position as Europe’s leading CNS specialist.”
Under the terms of the commercialization agreement, TG
Therapeutics will receive an upfront payment of $140 million plus
an additional $12.5 million upon launch in the first EU country and
is eligible to receive up to an additional $492.5 million in
milestone-based payments on achievement of certain launch and
commercial milestones. The total deal is valued at up to $645
million in upfront and milestone payments. In addition, TG will
receive tiered double-digit royalties on net product sales up to
30%. In exchange, Neuraxpharm will have the exclusive right to
commercialize BRIUMVI in territories outside the United States,
Canada, and Mexico, which are retained by TG, and excluding certain
Asian countries previously partnered. Additionally, TG Therapeutics
retains an option to buy back all rights under the
commercialization agreement for a period of two years in the event
of a change in control of TG.
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) for the treatment of adult patients with RMS who
have active disease defined by clinical or imaging features. With
this approval, the centralised marketing authorisation is valid in
all EU Member States, Iceland, Norway and Liechtenstein. Approval
in the United Kingdom (UK) and Switzerland will also be
pursued.
J.P. Morgan Securities LLC served as exclusive financial advisor
for TG Therapeutics, Inc. and DLA Piper provided legal counsel. PJT
Partners served as the financial advisor for Neuraxpharm and
Clifford Chance provided legal counsel.
CONFERENCE CALL INFORMATION TG Therapeutics
will discuss this announcement on a previously announced second
quarter 2023 conference call today at 8:30 AM ET. In order to
participate in the conference call, please call 1-877-407-8029
(U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG
Therapeutics.
A live webcast will be available on the Events page, located
within the Investors & Media section, of the Company's website
at www.tgtherapeutics.com. An audio recording of the conference
call will also be available for replay at www.tgtherapeutics.com
for a period of 30 days after the call
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 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 notbeen 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 SmPC 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.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 European Commission (EC)
approval for BRIUMVI to treat adult patients with RMS who have
active disease defined by clinical or imaging features. For more
information, visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and on LinkedIn.
ABOUT THE NEURAXPHARM GROUPNeuraxpharm is a
leading European specialty pharmaceutical company focused on the
treatment of the central nervous system (CNS), including both
psychiatric and neurological disorders. With more than 90% of its
sales in CNS, it has a unique understanding and in-depth knowledge
of this market built over 35 years. The company develops and
commercializes a portfolio of more than 120 molecules through a
direct presence in more than 20 countries in Europe, two in Latin
America, and globally via partners in more than 40 countries.
Neuraxpharm is constantly innovating, with new products and
solutions to address unmet patient needs and is expanding its
portfolio through its pipeline, partnerships and acquisitions.
Neuraxpharm recently acquired 17 CNS brands from Sanofi, expanded
its portfolio into medical devices and digital health with
mjn-neuro, and completed a strategic in-license agreement with
Minoryx for an orphan CNS indication. The company has a Health Tech
Center, with more than 50 scientists focused on innovation and
R&D, and manufactures part of its pharmaceutical products at
Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.
Neuraxpharm is backed by funds advised by the global private equity
firm, Permira. For more information, please visit
www.neuraxpharm.com.
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: |
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Investor Relations |
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Email: ir@tgtxinc.com |
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Telephone: 1.877.575.TGTX (8489), Option 4 |
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Media Relations: |
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Email: media@tgtxinc.com |
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Telephone: 1.877.575.TGTX (8489), Option 6 |
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NEURAXPHARM CONTACT INFORMATION: |
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Nick Bastin / Charlotte Hepburne-Scott / Zoe Bolt / Elena
Bates |
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Tel: +44 (0)203 882 9621 |
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Neuraxpharm@optimumcomms.com |
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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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