Source: Everest Medicines, Gilead
Aug.17.2022, Singapore ------ Everest Medicines (HKEX: 1952.HK, Everest), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has entered into an agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.
Aug.17.2022, Singapore ------ Everest Medicines (HKEX: 1952.HK, Everest), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has entered into an agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. (Nasdaq: GILD), whereby Immunomedics will obtain exclusive rights to develop and commercialize Trodelvy® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia.
An image from Everest Medicines Corporate Presentation 2021
Under the terms of the Agreement, Everest will receive up to $455 million in total considerations with $280 million in upfront payments payable subject to, among other things, certain regulatory approvals, and up to $175 million in potential future milestone payments. In addition, Everest will be released from payment obligations for up to $710 million in remaining milestone payments under a licensing agreement entered into with Immunomedics in April 2019 to develop, register, and commercialize Trodelvy® in Greater China, South Korea and certain other countries and territories. Under the Agreement, the licensing agreement will be terminated.
In China mainland and Singapore, Trodelvy is approved in June and January 2022 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. 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.
In China mainland and Singapore, Trodelvy is approved in June and January 2022 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. 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.
Kerry Blanchard, MD, PhD, Chief Executive Officer, Everest Medicines
“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 United States, Gilead is an ideal partner to further develop and commercialize Trodelvy in Asia Pacific regions to maximize patient access,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. “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.”
Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences
“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,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. “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.”
Ian Woo, President and Chief Financial Officer, Everest Medicines
“After the completion of this transaction, Everest’s resources will be more streamlined to invest into the ongoing development of our remaining pipeline of clinical-stage drug candidates with first-in-class or best-in-class potential. We will have a stronger balance sheet to advance our internal drug discovery efforts and execute synergistic strategic transactions,” said Ian Woo, President and Chief Financial Officer of Everest Medicines. “We will strive to deliver sustained value to our shareholders and to patients in Asia and worldwide.”
Trodelvy® from Gilead
About Trodelvy® (Sacituzumab Govitecan)
Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.
Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Under Everest’s licensing agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.
*The TRODELVY trademark is used under license from Gilead Sciences, Inc.
Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.
Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Under Everest’s licensing agreement with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, Trodelvy was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer and was also included in the updated 2022 Guidelines for Breast Cancer Diagnosis and Treatment of the Chinese Society of Clinical Oncology in April.
*The TRODELVY trademark is used under license from Gilead Sciences, Inc.
An image from Everest Medicines Annual Report 2021
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 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 eleven 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:
www.everestmedicines.com
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in 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 eleven 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:
www.everestmedicines.com
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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