TG Therapeutics and Neuraxpharm sign $650 million commercialization deal for multiple sclerosis treatment

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Multiple sclerosis Marketing marketing authorization

TG Therapeutics and Neuraxpharm have announced an agreement for the ex-US commercialization of BRIUMVI (ublituximab).

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 (RMS) that can be administered in a one-hour infusion, twice a year, following the starting dose.

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.

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.

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.

It 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, with approval in the UK and Switzerland currently being pursued.

Michael Weiss, TG’s CEO and chairman, stated: “We are very excited to be partnering with Neuraxpharm to launch BRIUMVI in Europe. Their neurology-focused approach, broad European platform and entrepreneurial organization really resonated with us as an attractive partner for BRIUMVI.”

“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, CEO of Neuraxpharm, added: “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.”

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.

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