TG Therapeutics has signed an ex-US commercialisation agreement with Neuraxpham Group to launch its multiple sclerosis treatment Briumvi (ublituximab) in Europe.
Briumvi is an anti-CD20 monoclonal antibody that has been approved in the US and European Union (EU) for relapsing forms of multiple sclerosis (RMS). Following the agreement, Neuraxpharm will also seek approvals in the UK and Switzerland.
As per the agreement, TG will receive a $140m upfront payment followed by an additional $12.5m after the launch of Briumvi in the first EU country. Additional milestone-based payments of up to $492.5m are based on certain launch and commercial milestones. The deal news came on the same day as the company’s Q2 financial results. Following both announcements, there was a 42.5% decline in TG’s stock price at market open today, compared to the market close yesterday.
In the Q2 earnings, TG Therapeutics reported he a loss of $86.8m and $47.6m for the H1 and Q2 of 2023. The Q2 sales for Briumvi were $16m.The agreement grants Neuraxpharm exclusive marketing rights in countries excluding countries under TG’s purview (US, Canada, and Mexico) and Asian countries for which TG has existing partnerships for commercialisation.
TG is also in line to receive royalties of up to 30% on net product sales. According to GlobalData, Briumvi is expected to generate $1.37bn in global sales in 2029.
GlobalData is the parent company of Pharmaceutical Technology.
TG has also reserved the option to buy back all the commercialization agreement rights for a two-year period should there be a change in the control of TG.
Other drugs in TG’s pipeline include TG-1801, an anti-CD47/CD19 bispecific antibody currently in Phase I trial (NCT03804996) for the treatment of B-cell lymphoma, and TG-1701, an irreversible Bruton’s tyrosine kinase inhibitor also in Phase I (NCT03671590) for the treatment of B-cell malignancies.