TG Therapeutics, Neuraxpharm enter ex-U.S. commercialization agreement

TG Therapeutics announced an agreement for the ex-US commercialization of BRIUMVI. BRIUMVI is the first and only anti-CD20 monoclonal antibody approved in the United States and European Union for adult patients with relapsing forms of multiple sclerosis 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. 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 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 and Switzerland will also be pursued.