China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene now resumes full control of global development, manufacturing, and commercialization of tislelizumab, with no further financial obligations to Novartis. Novartis will provide transitional services and support, while BeiGene will supply the drug for ongoing clinical studies.
Details of the Agreement and Financial Terms
The original 2021 deal between Novartis and BeiGene included an upfront fee of USD 650 million and potential milestone payments of up to USD 1.55 billion. The termination does not specify reasons for the decision, marking the end of Novartis’s recent collaboration with BeiGene. This follows another deal termination in July, where Novartis backed out of a development agreement for the TIGIT-targeted drug candidate ociperlimab, which involved a USD 300 million upfront payment. Consequently, BeiGene has received nearly USD 1 billion from Novartis with no return.
Positive Regulatory Progress for Tislelizumab
Despite the agreement termination, there is positive regulatory news for tislelizumab. BeiGene announced that the European Commission has approved tislelizumab as a monotherapy for treating unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) in patients previously treated with platinum-based chemotherapy. Additionally, the US FDA has accepted a market approval filing for tislelizumab as a first-line treatment for irresectable locally advanced, recurrent, or metastatic ESCC, with a decision expected in H2 2024.
Tislelizumab’s Global Clinical and Regulatory Landscape
Tislelizumab is the subject of 21 regulatory clinical studies across over 30 countries and has received 11 indication approvals in China. Ten Phase III pivotal studies have shown positive results, covering a range of cancers including non-small cell lung cancer, gastric cancer, ESCC, hepatocellular carcinoma, nasopharyngeal carcinoma, and others.-Fineline Info & Tech
