Everest Medicines Reaches Agreement with Gilead Sciences for Trodelvy in Asian Territories

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

Expands development and access to Trodelvy for patients in Greater China and select Asia-Pacific markets

Strengthens balance sheet and rationalizes resources to advance a strong portfolio of best-in-class, best-in-class drug candidates, and expand product portfolio through strategic transactions and internal drug discovery efforts

SHANGHAI, August 15, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest” or the “Company”), a biopharmaceutical company focused on the development and commercialization of transformative pharmaceuticals 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 development and commercialization rights to 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 its payment obligations until $710 million remaining milestone payments under a licensing agreement with Immunomedics in April 2019 develop, register and market Trodelvy® in Greater China, South Korea and certain other countries and territories. Under the agreement, the license agreement will be terminated.

Everest received approval on the 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 at least two prior systemic therapies, including at least one for metastatic disease. Everest has also submitted applications for commercial approval for Trodelvy in metastatic TNBC with regulatory agencies in South Korea, Taiwan and hong kong.

“We welcome the opportunity to restructure our partnership with Gilead, which was built on a shared vision to provide innovative oncology solutions to patients in need. With capital resources and a track record of successful therapeutic development and commercialization for Trodelvy in United StatesGilead is an ideal partner to continue the development and commercialization of Trodelvy in Asia Pacific regions to maximize patient access,” said Kerry Blanchard, MD, PhD, President and CEO of Everest Medicines. “I am extremely proud of what Everest has done to move Trodelvy forward in China and other Asia territories, and we will continue to bring more transformational therapies to patients in China and worldwide through our extensive portfolio of clinical and pre-clinical stage assets.”

“Trodelvy is approved for second-line metastatic TNBC in more than 35 countries. We thank Everest Medicines for its partnership and significant contributions to the development of Trodelvy in Asia. Their collaboration has brought us closer to bringing Trodelvy to patients who need alternative options,” said Bill GrosmanMD, PhD, Senior Vice President, Clinical Research in Oncology, 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 realize the clinical potential of Trodelvy across diverse tumor types. »

“After the completion of this transaction, Everest’s resources will be more streamlined to invest in the continued development of our remaining pipeline of clinical-stage drug candidates with first-in-class or best-in-class potential. We will have a better balance 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 lasting value to our shareholders and patients in Asia and around the world.”

Gilead will have the ability 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 advisor to the company.

Conference call information

A live conference call will be held on August 16, 2022 at 8:30 am Beijing Time (August 15, 2022 at 8:30 p.m. US Eastern Time).

The live webcast of the conference call will be available at https://www.acecamptech.com/eventDetail/60502830. Participants must register before the conference call.

Alternatively, participants can dial into the conference call using the login credentials below:

USA: +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
UK: +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 viewed by visiting the Company’s website at http://www.everestmedicines.com.

About Trodelvy® (Sacituzumab Govitecan)

Trodelvy is a first-in-class Trop-2 antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including 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 provides potent activity to Trop-2-expressing cells and the microenvironment.

Trodelvy is approved in more than 35 countries, with several additional regulatory reviews ongoing worldwide, for the treatment of adult patients with locally advanced or unresectable metastatic TNBC who have received at least two prior systemic therapies, including at least one for metastatic disease. Trodelvy is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received chemotherapy containing platinum and either a receptor programmed death ligand-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 development, registration and commercialization rights to Trodelvy for all indications. of cancer in Greater China, South Korea, and some Southeast Asian countries. In October 2020Trodelvy was included in the 2020 updated Chinese guidelines for the standardized diagnosis and treatment of advanced breast cancer and was also included in the 2022 updated guidelines for the diagnosis and treatment of breast cancer from the Chinese Society of Clinical Oncology in April.

*The TRODELVY trademark is used under license from Gilead Sciences, Inc.

About drugs Everest

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high quality clinical development, regulatory affairs, CMC, business development and operations in both China and with leading global pharmaceutical companies. Everest Medicines has built a pipeline of eleven potentially 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 diseases, cardio-renal diseases and infectious diseases. For more information, please visit their website at www.everestmedicines.com.

Forward-looking statements:

This press release may contain statements that constitute forward-looking statements, including descriptions concerning the current intention, belief or expectations of the Company or its officers with respect to the Company’s business activities and financial condition. , which can be identified by terminology such as “will”, “expect”, “anticipate”, “future”, “intend”, “plan”, “believe”, “estimate”, ” trust” and similar statements. These 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. Accordingly, actual results may differ from those in the forward-looking statements due to various factors and assumptions, such as future changes and developments in our business, the competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives is under no obligation and does not undertake to revise any forward-looking statements to reflect new information, future events or circumstances after the date of this press release, except as required by law. .

SOURCE Everest Medicines

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