AmericanPharmaceuticalReviewDecember 21, 2021
Tag: Novartis , BeiGene , Ociperlimab
Novartis announced the signing of an option, collaboration and license agreement with BeiGene, Ltd. for ociperlimab (BGB-A1217), expanding the company’s research and development activities in immuno-oncology. Ociperlimab is a late-stage TIGIT inhibitor, a novel class of anti-cancer therapies that blocks the TIGIT protein receptor. Ociperlimab is currently being evaluated in two Phase III lung cancer trials and additional studies are ongoing in a wide range of solid tumors.
Under terms of the agreement, Novartis will make an upfront payment to BeiGene of USD 300 million. A fee of up to USD 700 million would be paid to BeiGene if the option is exercised before late 2023. Upon exercise of the option, Novartis would obtain the development and commercialization rights to ociperlimab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Iceland, Liechtenstein, Switzerland, Russia and Japan. BeiGene agrees to provide 50 percent of the co-detailing efforts in the United States following approval and will retain the rights to ociperlimab in China and all other countries.
“This agreement adds a potentially transformative new therapy to our expanding immunotherapy platform and is part of the broad Novartis Oncology effort to drive the next wave of innovation in cancer treatments,” said Susanne Schaffert, PhD, President, Novartis Oncology. “Ociperlimab is a promising late-stage compound in non-small cell lung cancer, with potential in a wide range of solid tumors. We believe it is a strong candidate for potentially synergistic combination with the PD-1 inhibitor tislelizumab. We’re proud of the strong and innovative partnership we’ve established with BeiGene, as it builds on our previous collaboration with tislelizumab and will continue to help us reimagine medicine for people living with cancer.”
Ociperlimab is currently being studied in Phase III trials for advanced non-small cell lung cancer, and its development is complementary to the Novartis development plan for the PD-1 inhibitor tislelizumab. Early research suggests TIGIT inhibitors may be active against a broad range of tumors including lung, esophageal, gastric, breast cancer and melanoma.
During the option period, Novartis and BeiGene will collaborate on the clinical development of ociperlimab in combination with tislelizumab, with Novartis designing, sponsoring, conducting, and funding global combination clinical trials.
Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote a select number of Novartis Oncology products in the China broad market, leveraging the operational resources and expertise of the BeiGene team in specific regions that are not currently covered by Novartis. Novartis will continue to market the same selected products and its broad portfolio in areas where it currently has a commercial presence.
This market development partnership is expected to grow Novartis Oncology’s presence in China, where the company is committed to bringing novel treatments to patients.
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