TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)
2024-02-29
上市批准临床结果疫苗
Feb. 27, 2024 -- 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 IV
BRIUMVI 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.
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 THERAPEUTICS
TG 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.
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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