(RTTNews) – China-based biotechnology companyBeiGene Ltd. (BGNE) said that it will collaborate with Novartis to develop, manufacture and commercialize BeiGene’s cancer drug tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.
The companies have agreed to jointly develop tislelizumab in those licensed countries. Novartis will be 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, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.
As per the deal, 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.
As per the terms of the deal, 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 approved by the China National Medical Products Administration as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous non-small cell lung cancer or 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.
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