Gilead will acquire exclusive development and commercialisation rights of Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia

Gilead-16thAug

Gilead Sciences office in south of San Francisco, California. Credit: Cocoabiscuit/ Flickr (Creative Commons)

Everest Medicines has signed an agreement to transfer the exclusive rights to develop and commercialise Trodelvy (sacituzumab govitecan) in key Asian markets to Gilead Sciences.

As agreed, Everest Medicines will receive $280m in upfront payment and up to $175m upon achieving certain regulatory and commercial milestones. Additionally, Gilead may hire Everest employees who are directly working on the Trodelvy programme.

The deal is slated to close later this year, subject to customary closing conditions including approval from Everest’s shareholders.

Once complete, Gilead will acquire exclusive development and commercialisation rights of Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.

This year, Trodelvy was approved in mainland China and Singapore for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).

The antibody-drug conjugate was green lighted for use in patients who have received two or more prior systemic therapies including at least one for metastatic disease.

New drug applications for commercial approval for Trodelvy in metastatic TNBC have also been filed with regulatory bodies in South Korea, Taiwan and Hong Kong. Gilead will continue to work with the regulatory bodies to secure the approvals.

Gilead Sciences Oncology Clinical Research senior vice-president Bill Grossman said: “Trodelvy is approved for second-line metastatic TNBC in over 35 countries. We thank Everest Medicines for their partnership and important contributions in the development of Trodelvy in Asia. Their collaboration has brought us closer to bringing Trodelvy to patients who need alternative options.

“Trodelvy is the cornerstone of our solid tumour portfolio, and we are committed to bringing this transformative therapy to as many patients as possible. We look forward to rapidly advancing our development programme in Asia and to realizing the clinical potential of Trodelvy across diverse tumour types.”

In April 2019, Everest Medicines and Immunomedics signed an agreement that provided the former with an exclusive licence to develop and commercialise Trodelvy in certain Asian countries.

Subsequently, Gilead acquired Immunomedics in October 2020 and devised an extensive global clinical development programme that included assessing Trodelvy as a monotherapy and in novel combinations across multiple disease areas.

Last year, European Commission (EC) granted marketing authorisation for Trodelvy to treat TNBC.

Meanwhile, Gilead announced positive results from a study that was evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer.