Novartis has signed a strategic collaboration agreement to in-license from BeiGene, a Beijing-based pharmaceutical company, in major markets outside of China, tislelizumab, a drug for treating classical Hodgkin’s lymphoma and metastatic urothelial carcinoma, in a $2.2-billion deal ($650 million upfront, and up to $1.55 billion in milestone payments). 

Under the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the US, Canada, Mexico, the European Union, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. BeiGene will receive an upfront cash payment of $650 million from Novartis. BeiGene 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 products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved and marketed by BeiGene in China in two indications, classical Hodgkin’s lymphoma following at least two prior therapies and locally advanced or metastatic urothelial carcinoma with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation of the China National Medical Products Administration and are under review. These indications are first-line treatment of patients with advanced squamous non-small-cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric cancer, and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple combinations of tislelizumab with Novartis therapies in solid tumors.

The transaction has been approved by the Boards of Directors of both companies. Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

BeiGene’s $2.2-billion collaboration with Novartis follows a $3.2-billion collaboration formed between BeiGene and Amgen in 2020. 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