NVS Novartis AG

By Sarah Coffey

BeiGene Ltd. on Monday said it expanded its collaboration with Novartis Pharma AG to develop, manufacture and commercialize BeiGene's investigational TIGIT inhibitor ociperlimab in North America, Europe and Japan.

The companies also agreed to grant BeiGene rights to market, promote and detail five approved Novartis oncology products--Tafinlar dabrafenib, Mekinist trametinib, Votrient pazopanib, Afinitor everolimus, and Zykadia ceritinib--across designated regions of China.

The strategic collaboration is expected to advance clinical development of ociperlimab in combination with tislelizumab, including initiation and funding by Novartis of additional studies, the companies said.

BeiGene will receive an upfront cash payment of $300 million from Novartis, along with an additional payment of up to $700 million on exercise by Novartis of an exclusive time-based option prior to mid-2023 or between then and late-2023.

Following option exercise, BeiGene is eligible to receive up to $745 million on the achievement of regulatory approval milestones, $1.15 billion upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the licensed territory, which includes the U.S., Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.

Novartis will initiate and fund additional global clinical trials with ociperlimab and BeiGene has agreed to expand enrollment in two ongoing trials, the companies said. Following the option exercise, Novartis would share development costs of global trials.

BeiGene has agreed to provide 50% of the co-detailing and co-field medical efforts in the U.S., and has an option to co-detail up to 25% in Canada and Mexico, funded in part by Novartis. Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the parties' existing agreement.

Ociperlimab is an investigational potent TIGIT inhibitor with intact Fc function, believed to be critical for the anti-tumor activities of TIGIT antibodies. An immune checkpoint molecule, ociperlimab is currently being investigated in two global Phase 3 clinical trials, the AdvanTIG-301 and AdvanTIG-302 trials, in combination with tislelizumab in NSCLC.

Write to Sarah Coffey at sarah.coffey@wsj.com

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December 20, 2021 06:53 ET (11:53 GMT)

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