CAMBRIDGE, Mass. & BEIJING– BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced the closing of the collaboration and license agreement with Novartis Pharma AG, previously announced on January 11, 2021, to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody 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 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, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.
“Since the initial announcement of the collaboration with Novartis, our two companies have been preparing to execute on our opportunity to bring tislelizumab to more people around the world, whether through commercialization by Novartis in the licensed territory, by BeiGene in the rest of the world, or through combination clinical trials which we can each explore with our own pipelines or third-party agents,” said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. “In the short time since the collaboration was announced, we have achieved additional milestones for tislelizumab, with positive topline results for our global Phase 3 trial in patients with previously treated advanced unresectable or metastatic esophageal squamous cell carcinoma, and approval in China in combination with chemotherapy in first-line advanced squamous non-small cell lung cancer. We are excited to collaborate with Novartis to achieve the global opportunity of this potentially differentiated anti-PD-1 antibody.”
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.
