Everest Medicines Enters into Agreement with Gilead Sciences for Trodelvy in Asia Territories

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Aug 15, 2022, 19:15 ET

Everest to receive total considerations of up to $455 million with $280 million in upfront payments

Broadens development and access to Trodelvy for patients in Greater China and certain Asia Pacific Markets

Strengthens balance sheet and streamlines resources to advance robust pipeline of first-in-class and best-in-class drug candidates, and expand product portfolio through strategic transactions and internal drug discovery efforts

SHANGHAI, Aug. 15, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), 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 (the "Agreement").

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.

Everest received approval in mainland China and Singapore in June and January 2022, respectively, for Trodelvy® in 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. Everest has also submitted applications for commercial approval for Trodelvy in metastatic TNBC with regulatory bodies in South Korea, Taiwan and Hong Kong.

"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."

"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."

"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."

Gilead will have the opportunity to recruit Everest employees working directly on the Trodelvy program.

Goldman Sachs served as financial advisor to Everest Medicines while Ropes & Gray LLP served as legal counsel to the Company.

Conference Call Information

A live conference call will be hosted on August 16, 2022 at 8:30 AM Beijing Time (August 15, 2022 at 8:30 PM U.S. Eastern Time).

The live webcast of the conference call will be available at https://www.acecamptech.com/eventDetail/60502830. Participants need to register in advance of the conference call.

Alternatively, participants may dial in to the conference call using below dial-in information:

United States: +1 646 254 3594 English
Mainland China: +86 10 5808 4166 English
+86 10 5808 4199 Chinese
Hong Kong: +852 3005 1313 English
+852 3005 1355 Chinese
United Kingdom: +44 20 7660 0166 English
International: +1 866 636 3243 English
Password: 029169

A replay will be available shortly after the call and can be accessed by visiting the Company's website at http://www.everestmedicines.com.

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.

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 its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

SOURCE Everest Medicines