Global Briefs: Gilead & Sanofi
Gilead To Acquire China, Asian-Pacific Rights of Breast Cancer Drug in $455-M Deal
Gilead Sciences has agreed to acquire the development and commercialization rights for Gilead’s breast cancer drug, Trodelvy (sacituzumab govitecan), in China and select Asian-Pacific countries from Everest Medicines, a New York-based bio/pharmaceutical company, in a deal worth up to $455 million ($280 million upfront and $175 million in milestone payments). Everest Medicines previously licensed the rights to Trodelvy in China and select Asian-Pacific countries from Immunomedics, a Morris Plains, New Jersey-based bio/pharmaceutical company, which Gliead acquired in 2020 for $21 billion.
Under the deal, Gilead would acquire the rights to Trodelvy in China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia, and Mongolia.
Trodelvy is approved in China and Singapore for treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Gilead continues to work with regulatory bodies in Hong Kong, South Korea, and Taiwan, where new drug applications, filed by Everest Medicines for metastatic TNBC, are currently under review.
In all, Trodelvy is approved in over 35 countries for treating TNBC. It is also approved in the US for treating locally advanced or metastatic urothelial cancer. It is also being evaluated for treating non-small cell lung cancer, small-cell lung cancer, gastrointestinal cancers, head and neck cancer, and endometrial cancer.
The transaction is expected to close later this year (2022), and is subject to customary closing conditions, including approval by Everest’s shareholders. Gilead will also have the opportunity to recruit Everest employees working directly on the Trodelvy program. Upon closing of the deal, Gilead would have acquired all worldwide rights to Trodelvy.
Source: Gilead Sciences
Sanofi Discontinues Last-Stage Development of Breast Cancer Drug
Sanofi has decided to discontinue the development of amcenestrant, its investigational breast cancer drug in Phase III development and will not seek regulatory approval for its use. The company decided to discontinue development following an interim analysis of a Phase III study evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. The drug failed to meet the prespecified boundary for continuation in its Phase III trial when compared with the control arm.
All other studies of amcenestrant, including in early-stage breast cancer, will be discontinued.