New deal grants Neuraxpharm rights to market Briumvi in Europe

The specialty pharmaceutical company Neuraxpharm will be responsible for marketing the multiple sclerosis (MS) therapy Briumvi (ublituximab) in regions outside the U.S., Canada, Mexico, and certain Asian countries as part of a new collaboration with TG Therapeutics worth $140 million in upfront payments alone.

Neuraxpharm is a leading pharma company in Europe focused on the treatment of central nervous system (CNS) disorders, or those affecting the brain and spinal cord. It’s now planning to make Briumvi available in the European Union — where it was approved in June for adults with active, relapsing forms of MS — within the next six months.

“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,” Michael S. Weiss, chairman and CEO of TG Therapeutics, said in a company press release.

Under the terms of the collaboration, TG Therapeutics will receive an upfront payment of $140 million and an additional $12.5 million when the drug is launched in the first EU country.

“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,” said Jörg-Thomas Dierks, CEO of Neuraxpharm.

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An anti-CD20 antibody therapy, Briumvi is designed to eliminate B-cells, immune cells that play a key role in driving MS. The medication is given as intravenous or into-the-vein infusions. After two initial infusions, two weeks apart, it is administered via hourlong infusions every six months.

Briumvi was approved in the U.S. in late 2022 and more recently in the European Union — an approval that extends to all EU member states, as well as Iceland, Norway, and Liechtenstein. TG Therapeutics also plans to seek approvals in the U.K. and Switzerland in the future, the company said.

Since its approval in the U.S., more than 1,200 prescriptions from more than 340 healthcare providers have been filled, TG Therapeutics announced in a corporate update on Aug. 1. Also, payor coverage is in place for approximately 80% of covered lives for Briumvi.

The new agreement with Neuraxpharm is expected to make Briumvi available to more patients in Europe.

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.

The company will hold exclusive rights to sell Briumvi outside North America — the U.S., Canadian, and Mexican markets will be retained by TG Therapeutics. Certain Asian countries in which TG had made marketing deals with other companies also are excluded from the agreement.

Under the terms of this deal, TG Therapeutics will be eligible for additional payments of up to $492.5 million upon the achievement of certain launch and commercial milestones. In total, the deal sums up to $645 million, and the company also will receive tiered double-digit royalties on net product sales up to 30%.

Yet, TG Therapeutics will retain the an option to buy all rights back for a period of two years, in the event of its acquisition.

“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,” Dierks said.

“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,” Dierks added.