The collaboration will help Novartis expand its oncology portfolio with late-stage PD-1 for monotherapy and potential PD-1 combinations
Novartis has entered into collaboration and license agreement with BeiGene, a commercial-stage biotechnology firm, to develop, manufacture and commercialise the latter’s cancer drug tislelizumab in markets outside of China.
Under the terms of the agreement, Novartis will receive the rights to develop and commercialise tislelizumab for an upfront payment of $650m in addition to royalties and milestone payments.
The Swiss drugmaker will develop and commercialise the drug in the US, Canada, Mexico, EU member countries, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan, while BeiGene will retain the rights to tislelizumab in China and other countries.
Also, BeiGene is entitled to receive up to $1.3bn, subject to meeting the regulatory milestones, $250m upon reaching the sales milestones, and royalties on future sales.
Novartis Oncology president Susanne Schaffert said: “Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders.
“This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy.
“No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient.
“We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients.”
Tislelizumab is an anti-PD-1 monoclonal antibody, specifically designed to prevent the binding to FcγR on macrophages, for the activation of antibody-dependent macrophage-mediated killing of T effector cells.
The drug has been approved by the China National Medical Products Administration (NMPA) for treating certain classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
BeiGene has filed three supplemental new drug applications for tislelizumab in treating advanced squamous NSCLC plus chemotherapy, advanced non-squamous NSCLC plus chemotherapy, and previously treated unresectable HCC, in China.
Under the new collaboration, BeiGene will fund the ongoing clinical trials of tislelizumab, while Novartis to fund new registrational, bridging, or post-marketing studies.
Furthermore, Novartis and BeiGene have identified several clinical trial opportunities for tislelizumab plus Novartis therapy combination, to treat solid tumours.
BeiGene co-founder, CEO and chairman John Oyler said: “We are excited to collaborate with Novartis to further explore the potential of tislelizumab in multiple combinations and indications. Novartis is a well-recognized leader in oncology with a unique portfolio of cancer treatments and pipeline agents.
“This important collaboration stands on a strong foundation of tislelizumab’s broad global development program, which has delivered two approvals in China, currently spans 15 potentially registration-enabling clinical trials, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside of mainland China.
“We look forward to working with Novartis to fulfil the global opportunity of this potentially differentiated anti-PD-1 antibody.”