Gilead to acquire remaining worldwide rights of breast cancer drug, Trodelvy

August 19, 2022 - 3 minutes
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All of Everest Medicine’s development and commercialization rights for a breast cancer drug called Trodelvy have been transferred to American biopharma Gilead Sciences Inc.

The transfer of the antibody drug, sacituzumab govitecan treatment, will apply to Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.

In China mainland and Singapore, Trodelvy is approved for the treatment of adult patients with 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.

New Drug Applications for Trodelvy 

Gilead continues to work closely 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.

Bill Grossman, senior vice president of oncology clinical research at Gilead Sciences, 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 tumor portfolio, and we are committed to bringing this transformative therapy to as many patients as possible. We look forward to rapidly advancing our development program in Asia and to realizing the clinical potential of Trodelvy across diverse tumor types.”

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Exclusive license

In April 2019, Everest Medicines and Immunomedics entered into an agreement granting Everest Medicines an exclusive license to develop and commercialize Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia, excluding Japan.

Gilead subsequently acquired Immunomedics in October 2020 and created an extensive global clinical development program, including investigating Trodelvy as a monotherapy. It is also looking at it in novel combinations, across multiple disease areas including non-small cell lung cancer, metastatic urothelial cancer and gastrointestinal cancers.

Kerry Blanchard, chief executive officer at Everest Medicines, said: “We welcome the opportunity to restructure our partnership with Gilead, which has been built on a shared vision of providing innovative oncology solutions for patients in need.

“With capital resources and a track record of successful therapeutic development and commercialization for Trodelvy in the U.S., Gilead is an ideal partner to further develop and commercialize Trodelvy in Asia Pacific regions to maximize patient access.

Asia territories

“I am exceedingly proud of what Everest has accomplished in advancing Trodelvy in China and other Asia territories, and we will continue to bring more transformational therapies to patients in China and worldwide with our extensive pipeline of clinical and pre-clinical stage assets.”

Under the terms of the agreement, Gilead will make a $280 million (€275 million) upfront payment to Everest. In addition, Everest is eligible to receive up to $175 million (€172 million) in potential additional payments upon achievement of certain regulatory and commercial milestones.

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Gilead will also have the opportunity to recruit Everest employees working directly on the Trodelvy program. The transaction is expected to close later this year, and will be subject to customary closing conditions, including approval by Everest’s shareholders.

Earlier this month, California-headquartered Gilead and MiroBio, a privately-held U.K.-based biotech company announced the companies have entered into a definitive agreement with Gilead acquiring MiroBio for approximately $405 million in cash, subject to customary adjustments.

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