TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy)
TG Therapeutics' ex-US partner, Neuraxpharm, launches BRIUMVI in Germany for the treatment of multiple sclerosis, triggering a milestone payment of $12.5 million to TG Therapeutics.
The launch of BRIUMVI in Germany by Neuraxpharm represents a significant milestone for TG Therapeutics, as it marks the drug's entry into the European market. The immediate impact is the $12.5 million milestone payment, which could provide a short-term financial boost to TG Therapeutics. However, the long-term implications are more substantial. The success of BRIUMVI in Europe will depend on market penetration, acceptance by the medical community and patient outcomes. As Germany is often seen as a bellwether for pharmaceutical success in Europe, a strong performance there could signal a positive trajectory for the drug's rollout in other European countries.
Moreover, the CNS disorder treatment market is competitive and the effectiveness of BRIUMVI against relapsing forms of multiple sclerosis will be closely monitored. The market response could influence investor sentiment and the stock's performance. Positive clinical outcomes and patient feedback could lead to increased demand and higher sales, whereas any negative reports could dampen expectations and affect the stock negatively.
With the European Commission and MHRA approvals in place, BRIUMVI's launch in Germany is a critical step for TG Therapeutics in expanding its global footprint. The European market is highly regulated and gaining approval indicates a rigorous review process and a strong scientific backing for the drug's efficacy and safety. As a treatment for relapsing forms of multiple sclerosis, BRIUMVI addresses a chronic condition that affects a significant patient population, offering a potential improvement in the quality of life for those with active disease.
Understanding the clinical profile of BRIUMVI and how it compares to existing treatments will be essential for healthcare providers and payers. Its long-term success will hinge on its ability to demonstrate superior outcomes or a better safety profile compared to other treatments. For investors, the drug's performance in the real-world setting will be a key indicator of TG Therapeutics' potential return on investment.
From a financial perspective, the launch of BRIUMVI in Germany could be seen as a strategic move for TG Therapeutics. The milestone payment of $12.5 million is a clear immediate financial benefit. However, the broader financial implications will unfold as the drug gains traction in the European market. Investors will be keenly observing the sales figures post-launch, as Europe represents a significant market opportunity for BRIUMVI.
Additionally, the structure of the commercialization agreement with Neuraxpharm will likely include royalties or profit-sharing on European sales, which could become a steady revenue stream for TG Therapeutics if BRIUMVI is successful. The company's financial projections and guidance may need to be adjusted based on the European performance of BRIUMVI, which could have a material impact on the stock valuation.
02/26/2024 - 07:00 AM
Ex-US partner, Neuraxpharm, launches BRIUMVI in Germany, the first European country
NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- 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.”
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
Highlights from the EU Label for BRIUMVI®
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 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 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 THERAPEUTICS www.tgtherapeutics.com , and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn .Cautionary Statement
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.Investor Relations ir@tgtxinc.com Media Relations: media@tgtxinc.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.
What is the name of the drug launched by Neuraxpharm in Germany?
The drug launched by Neuraxpharm in Germany is BRIUMVI.
What is the indication for BRIUMVI in Europe?
BRIUMVI is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have active disease defined by clinical or imaging features.
Which European country saw the first launch of BRIUMVI?
Germany saw the first launch of BRIUMVI.
How much milestone payment will TG Therapeutics receive for the first launch of BRIUMVI in a European country?
TG Therapeutics will receive a milestone payment of $12.5 million for the first launch of BRIUMVI in a European country.
When did TG Therapeutics enter into a commercialization agreement with Neuraxpharm for BRIUMVI?
TG Therapeutics entered into a commercialization agreement with Neuraxpharm for BRIUMVI in August 2023.
