Novartis, BeiGene Close $2.2-Bn Licensing Deal for Oncology Drug

Novartis has closed on its $2.2-billion licensing agreement and collaboration with BeiGene, a Beijing-based pharmaceutical company, for tislelizumab, an oncology drug. Earlier this year (January 2021), the companies agreed to a $2.2-billion in-licensing deal ($650 million upfront, and up to $1.55 billion in milestone payments) for tislelizumab in major markets outside of China.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin’s lymphoma, and metastatic urothelial carcinoma. Tislelizumab is not approved for use outside of China. Tislelizumab is also being studied in non-small cell lung cancer, gastric cancer, hepatocellular carcinoma, and nasopharyngeal carcinoma, with broad potential in several other solid tumors.

Under the announced deal, Novartis agreed to obtain the development and commercialization rights to tislelizumab in the US, Canada, Mexico, the European Union, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. The companies agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments. In addition, BeiGene has an option to co-detail the product in North America, funded in part by Novartis.

Under the collaboration and license agreement, BeiGene will receive an upfront cash payment of $650 million and is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. BeiGene will be responsible for funding ongoing clinical trials of tislelizumab. Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third-party agents. Each party retains worldwide rights to commercialize its proprietary products in combination with tislelizumab. Novartis says it has identified multiple opportunities to combine tislelizumab with other therapies in the Novartis portfolio and pipeline

BeiGene’s $2.2-billion collaboration with Novartis is a second recent deal with a large pharmaceutical company. In 2020, BeiGene formed two deals with Amgen for $3.2-billion. In January (January 2020) Amgen formed a global strategic oncology collaboration with BeiGene and took an equity stake in the company for $2.8 billion for the commercialization and development in China of three Amgen oncology drugs: Xgeva (denosumab) for treating giant cell tumors of the bone; Kyprolis (carfilzomib) for treating multiple myeloma; and Blincyto (blinatumomab) for treating relapsed or refractory acute lymphoblastic leukemia. The companies also agreed to collaborate for the joint global development of 20 oncology assets in Amgen’s pipeline with BeiGene responsible for development and commercialization in China. In July 2020, Amgen made an additional investment of $421 million in BeiGene.

Source: Novartis and BeiGene

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