Everest Medicines Announces that the US FDA has Granted Licensing Partner Gilead Sciences, Inc. Accelerated Approval of Trodelvy® for the Treatment of Metastatic Urothelial Cancer

Almost 1/3 of Patients in Pivotal TROPHY Study Responded to Treatment

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Apr 14, 2021, 09:25 ET

SHANGHAI, April 14, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy^® (sacituzumab govitecan-hziy) to Gilead Sciences, Inc. (Nasdaq: GILD), a licensing partner of Everest Medicines, for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

The accelerated approval was based on data from the Phase 2, single-arm TROPHY study of 112 patients, which found that Trodelvy^®achieved a 27.7% overall response rate with a 7.2-month median duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

"This accelerated approval of Trodelvy^® for metastatic UC, a devastating disease with previously limited treatment options, marks an exciting milestone for patients in the U.S. and around the world," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "We applaud Gilead Sciences for its extensive and encouraging datasets as well as its comprehensive and ongoing global regulatory strategy in this important disease area. At Everest Medicines, we look forward to continuing to advance late-stage development of Trodelvy^® for patients in Greater China and other parts of Asia as part of the collective effort to make this innovative treatment available to patients around the world."

In December 2020, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic UC. Everest Medicines plans to enroll patients in China as part of global Phase 3 TROPiCS-04 confirmatory trial, which is underway and is also intended to support global registrations.

About Urothelial Cancer

Urothelial cancer is a type of cancer that begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. According to Frost & Sullivan, in 2019, the incidence of urothelial cancer reached 76,400 in China.

About Trodelvy^® (sacituzumab govitecan-hziy)

Trodelvy^® (sacituzumab govitecan-hziy) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers.

In addition to its indication in locally advanced or metastatic UC, Trodelvy^® is approved in the U.S. to treat 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.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

SOURCE Everest Medicines