US pharmaceutical major Gilead Sciences Inc. (NASDAQ: GILD) today announced an agreement with Everest Medicines (HKG: 1952) to transfer the development and commercialization rights for Trodelvy (sacituzumab govitecan) in Asian territories. Trodelvy is a TROP-2 targeted antibody drug conjugate (ADC). The deal regains control of the drug’s Asian rights for Everest, which previously licensed them from Immunomedics in April 2019. Gilead acquired Trodelvy when it bought Immunomedics for USD21 billion in October 2020.
Agreement Details
Under the agreement, Gilead will pay Everest an upfront payment of USD280 million to regain control of development and commercialization rights in Asia. Everest is also eligible to receive up to USD175 million in additional payments upon achieving certain regulatory and commercial milestones. Gilead will have the opportunity to recruit Everest employees directly involved in the Trodelvy program. The transaction is expected to close later this year, subject to customary closing conditions, including approval by Everest’s shareholders.
Previous Deal and Approvals
The April 2019 deal between Everest and Immunomedics involved a USD65 million upfront payment, with an additional USD60 million upon US FDA approval for Trodelvy in metastatic triple-negative breast cancer (TNBC), alongside USD710 million in further milestone commitments. The territories included Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia, and Mongolia. Trodelvy received its first US approval for TNBC in April 2020 and for metastatic urothelial carcinoma in April 2021. Everest has already secured approvals for Trodelvy in mainland China and Singapore for the TNBC indication.
Gilead’s Global Development Program
Gilead noted that it has established an extensive global clinical development program for Trodelvy, both as a monotherapy and in novel combinations, across multiple disease areas including non-small cell lung cancer, metastatic urothelial cancer, and gastrointestinal cancers. The company stated it is working closely with regulatory bodies in Hong Kong, South Korea, and Taiwan regarding New Drug Applications filed by Everest Medicines for metastatic TNBC, which are currently under review.-Fineline Info & Tech
