BeiGene has signed an agreement with Novartis to regain global rights related to the humanised IgG4 anti-PD-1 antibody, TEVIMBRA (tislelizumab).
Both parties have agreed to end their previous collaboration and licence agreement, which was signed in January 2021.
Under the new agreement, BeiGene has regained complete global rights to TEVIMBRA, without owing royalties to Novartis, for the development, manufacturing and commercialisation of this antibody.
Novartis will offer transition services along with support to BeiGene to facilitate the progression of key aspects within the TEVIMBRA development and commercialisation plan.
This will encompass key areas such as manufacturing, regulatory processes, safety measures and clinical support.
BeiGene has committed to supporting Novartis with the ongoing clinical supply of TEVIMBRA in support of its trials.
BeiGene co-founder, chairman and CEO John Oyler said: “We are excited to regain the global rights to TEVIMBRA, which enables us to build out our in-house solid tumour commercial capabilities and complements our deep pipeline presented at our recent R&D Day.
“With more than 12,000 patients enrolled in our TEVIMBRA global clinical trial programme, we plan to rapidly accelerate our regulatory and development plans across a wider range of tumour types.”
As part of the previous agreement, both the entities were jointly developing TEVIMBRA in Canada, EU member countries, Iceland, Japan, Liechtenstein, Mexico, Norway, Russia, Switzerland, the UK and the US..
Under the deal, Novartis was responsible for submissions to regulatory authorities and had the right to market the product in the licensed countries once it received regulatory approval.
TEVIMBRA has been designed to reduce binding to Fc-gamma (Fcγ) receptors on macrophages to assist the body’s immune cells in detecting and fighting tumours.
It is currently under assessment by the European Medicines Agency (EMA) and the US Food and Drug Administration for advanced or metastatic oesophageal squamous cell carcinomas (ESCC) after prior chemotherapy.