TG Therapeutics Announces European Launch of BRIUMVI (ublituximab-xiiy)

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.”

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 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.