TG Therapeutics, Inc. and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, have announced an agreement for the ex-US commercialisation of BRIUMVI (ublituximab). BRIUMVI is the first and only anti-CD20 monoclonal antibody approved in the United States (US) and European Union (EU) for adult patients with relapsing forms of multiple sclerosis (RMS) 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.
Michael S. Weiss, TG’s Chairman and Chief Executive Officer, stated, “We are very excited to be partnering with Neuraxpharm to launch BRIUMVI in Europe. Their neurology-focused approach, broad European platform and entrepreneurial organisation really resonated with us as an attractive partner for BRIUMVI.” Mr. Weiss continued, "From a deal perspective, the terms provided us many important benefits, including an upfront payment further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-US success of BRIUMVI, an experienced neurology team ready to rapidly launch BRIUMVI, and the strategic flexibility to buy back the commercial rights over the next two years in the event of an acquisition of TG.”
Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, stated, “As the leading CNS Company in Europe with direct presence in over 20 countries, we believe BRIUMVI is an ideal product to bring within our portfolio, and its unique attributes support its potential to become a leading treatment option for patients with relapsing forms of MS. We are committed to the success of BRIUMVI, due to the positive impact it can make on patients’ lives, and we will be making BRIUMVI our highest priority, adding 100+ new MS specialists to our already deep CNS commercial team. We look forward to working with TG Therapeutics and launching BRIUMVI in Europe within the next six months, building further on Neuraxpharm’s position as Europe’s leading CNS specialist.”
Under the terms of the commercialisation 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 commercialise 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 commercialisation 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 (EC) 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 (UK) and Switzerland will also be pursued.
J.P. Morgan Securities LLC served as exclusive financial advisor for TG Therapeutics, Inc. and DLA Piper provided legal counsel. PJT Partners served as the financial advisor for Neuraxpharm and Clifford Chance provided legal counsel.