TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI (ublituximab-xiiy)

Newly issued patents extend exclusivity of ublituximab through 2042

NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- 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.