Eight months after Briumvi’s initial green light in the U.S., TG Therapeutics is preparing to debut its multiple sclerosis antibody on the world stage.
In a deal unveiled Tuesday, European specialty pharmaceutical company Neuraxpharm will throw TG an upfront payment of $140 million—plus an additional $12.5 million upon Briumvi’s first EU launch—to chip in on commercialization of TG’s CD20-targeting drug outside the U.S.
TG is eligible to receive another $492.5 million in launch and commercialization milestones, for a total deal value of $645 million, the companies said in a release.
Aside from milestones, TG is in line to receive tiered double-digit percentage royalties based on net product sales, with the royalties capping out at 30%. In exchange, Neuraxpharm is getting its hands on exclusive rights to market Briumvi in areas outside the U.S., Canada and Mexico, which are retained by TG, plus some previously partnered Asian countries.
TG also says it’s holding on to an option to buy back all rights handed over to Neuraxpharm for a period of two years “in the event of a change in control of TG.”
Briumvi scored in its initial approval in the U.S. back in December. Cleared in relapsing multiple sclerosis, TG’s drug faced an uphill climb against entrenched competitors such as Roche’s Ocrevus, Novartis’ Kesimpta and Biogen’s Tecfidera.
But unlike Novartis’ anti-CD20 treatment Kesimpta, which is injected once a month, Briumvi is designed as a one-hour infusion post-starting dose, after which patients need only receive a 450-mg dose administered over one hour every six months. Roche’s Ocrevus is also administered every 24 weeks (PDF) after a series of starting doses.
Briumvi won its European green light at the start of June, clearing the way for successive launches across the bloc. The company is also pursuing nods in the U.K. and Switzerland.
Neuraxpharm, for its part, figures Briumvi is an “ideal product” to add to its portfolio, according to the group’s CEO Jörg-Thomas Dierks, M.D. As part of the deal, Neuraxpharm is fitting another 100 new multiple sclerosis specialists into its “already deep CNS commercial team,” the company added.
For the second quarter of 2023, Briumvi brought home U.S. sales of $16 million, representing 100% quarter-over-quarter growth. According to TG, more than 340 healthcare providers at 225-plus centers across the U.S. have written more than 1,200 Briumvi prescriptions since launch.