Home Everest Medicines and Gilead Sciences Announce Agreement on Trodelvy® Rights in Asia

Everest Medicines and Gilead Sciences Announce Agreement on Trodelvy® Rights in Asia

Aug 16, 2022 07:15 CST Updated 07:15
Everest Medicines

Developer of Innovative Therapies

Gilead Sciences

Antiviral Drug Developer

Immunomedics

Developer of Targeted Cancer Therapies

Everest Medicines will receive a total amount4.55USD billion as the consideration, including an upfront payment2.8Billion US dollars

The agreement is beneficial for the expansion of Trodelvy.®Development and Patient Access in Greater China and Specific Asia-Pacific Markets

The transaction will strengthen Everest Medicines' financial position and optimize resources to further develop other first-in-class and best-in-class drug candidates in the R&D pipeline, while expanding the product portfolio through strategic transactions and independent drug development.

ShanghaiAugust 16, 2022/PR Newswire/ --Everest Medicines(HKEX 1952.HK) is a biopharmaceutical company focused on the development and commercialization of innovative drugs, dedicated to addressing unmet medical needs in the Asia-Pacific market, and announced a collaboration with Gilead Sciences (Gilead Sciences, Inc.Nasdaq: GILD) subsidiary Immunomedics, Inc. to transfer the development and commercialization rights of Trodelvy in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia, and Mongolia to Everest Medicines.®(The English trade name is Trodelvy®, sacituzumab govitecan) The exclusive rights were transferred to Immunomedics.

According to the agreement, Everest Medicines will receive a total consideration of US$455 million, including an upfront payment of US$280 million (subject to approval by relevant regulatory authorities) and futurePotentialMilestone payment of $175 million. In addition, Everest Medicines will no longer be required to pay the remaining high-limit milestone payment of $710 million from the licensing agreement signed with Immunomedics in April 2019. The original agreement granted Everest Medicines the rights to develop, register, and commercialize Trodelvy in Greater China, South Korea, and other specific countries and regions.®The rights. According to the agreement announced today, the original license agreement will be terminated.

Everest Medicines was approved for Trodelvy in China and Singapore in June and January 2022, respectively.®Approved for marketing to treat 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 treatment for metastatic disease. Everest Medicines has also submitted Trodelvy to the pharmaceutical regulatory authorities in South Korea, Taiwan, China, and Hong Kong, China.®Marketing Authorization Application for the Treatment of Metastatic Triple-Negative Breast Cancer.

Dr. Kerry Blanchard, CEO of Everest Medicines, stated: "We welcome this restructuring of our collaboration with Gilead Sciences, which has always been based on the shared vision of providing innovative solutions for cancer patients in urgent need of treatment. With financial resources and successful development and commercialization of Trodelvy in the United States, ..."®'s experience, Gilead is our further development and commercialization of Trodelvy in the Asia-Pacific region®An ideal partner to maximize patient accessibility. For Everest Medicines advancing Trodelvy in China and other Asian regions®"I am extremely proud of the achievements we have made. With our extensive clinical and preclinical product pipeline, we will continue to bring more transformative therapies to patients in China and around the world."

Bill Grossman, Ph.D., Senior Vice President of Oncology Clinical Research at Gilead Sciences, said: "Trodelvy®Has been approved in more than 35 countries/regions for second-line treatment of metastatic triple-negative breast cancer. We thank Everest Medicines for their efforts in past collaborations and for Trodelvy.®In important contributions made by the development in Asia. The collaboration with Everest Medicines brings us closer to delivering Trodelvy.®A step forward for patients in need of alternative treatment options. Trodelvy®It is the cornerstone of our solid tumor product portfolio, and we have been committed to bringing this transformative therapy to as many patients as possible. We hope to rapidly advance the development program in Asia and fully realize the potential of Trodelvy.®The Clinical Potential for Treating Different Types of Tumors

Everest Medicines President and Chief Financial Officer, He Ying, stated: "After the completion of the transaction, Everest Medicines will optimize resources to allocate more funds towards other product pipelines under development, which include multiple clinical candidates with first-in-class or best-in-class potential. We will also achieve a more robust financial position, allowing us to continue advancing our proprietary drug research and development as well as engage in strategic transactions. We will, as always, create value for our shareholders and for patients across Asia and globally."

Gilead Sciences will offer recruitment opportunities to Everest Medicines employees who were directly involved in the Trodelvy project.

Goldman Sachs served as the financial advisor for Everest Medicines in this transaction, and Ropes & Gray LLP served as the legal advisor.

Conference Call Information:

The teleconference will be held at 8:30 AM Beijing Time on August 16 (8:30 PM Eastern Time on August 15 in the United States).

Live streaming link:https://www.acecamptech.com/eventDetail/60502830.Participants need to register before the teleconference.

At the same time, participants can also use the following dial-in information to join the teleconference:

United States:                 +1 646 254 3594        English
Mainland China:          +86 10 5808 4166      English
+86 10 5808 4199 English
Hong Kong:             +852 3005 1313         English
+852 3005 1355 English
UK:                   +44 20 7660 0166      English
International:               +1 866 636 3243         English
Conference Dial-in Code: 029169

After the meeting, you can visit the Everest Medicines official website (http://www.everestmedicines.com) Listen to the conference replay.

About Trodelvy®(English Product Name:Trodelvy®, Generic Name in China: Sacituzumab Govitecan)

Trodelvy®It is a first-in-class antibody-drug conjugate targeting the Trop-2 receptor, a cell surface antigen overexpressed in various types of tumors (including over 90% of breast and bladder cancers). Trodelvy® features a hydrolysable linker that connects to the payload, the topoisomerase I inhibitor SN-38. This unique design ensures potent activity in both Trop-2 expressing cells and the surrounding microenvironment.

Trodelvy®Has been approved in more than 35 countries/regions and is under review by additional regulatory authorities worldwide for the treatment of 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 therapy for metastatic disease. Trodelvy®Also received accelerated approval in the United States for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received platinum-based chemotherapy and a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor.

According to the previous licensing agreement signed with Immunomedics, Inc., a wholly-owned subsidiary of Gilead Sciences, Everest Medicines has exclusive rights to Trodelvy in Greater China, South Korea, and certain Southeast Asian countries.®(Trodelvy®) Exclusive rights to develop, register and commercialize all cancer indications. In October 2020, Trodelvy®Included in the updated 2020 edition of "Chinese Guidelines for Standard Diagnosis and Treatment of Advanced Breast Cancer." In October 2021, included in "Chinese Anti-Cancer Association Guidelines and Standards for Diagnosis and Treatment of Breast Cancer (2021)." In April 2022, also included in the updated "2022 Chinese Society of Clinical Oncology Guidelines for Diagnosis and Treatment of Breast Cancer."

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

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on the development and commercialization of innovative medicines, dedicated to addressing unmet medical needs in the Asian market. The management team of Everest Medicines has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, chemistry, manufacturing and control (CMC), business development, and operations within China and leading global pharmaceutical enterprises. Everest Medicines has built a portfolio of 11 drug candidates with the potential to be either first-in-class or best-in-class globally, most of which are already in the late stages of clinical trials. The company’s therapeutic areas include oncology, autoimmune diseases, cardiorenal diseases, infectious and communicable diseases. For more information, please visit the company's website:www.everestmedicines.com

Forward-Looking Statements

The information contained in this press release may include certain forward-looking statements based on the Company's or management’s current views, beliefs, and expectations about the Company’s business operations and financial condition at the time of making such statements. These statements may be expressed using terms such as "will," "expect," "forecast," "anticipate," "intend," "plan," "believe," "estimate," "confident," and other similar expressions. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the Company’s control and difficult to predict. Therefore, actual results may differ materially from those projected in the forward-looking statements due to various factors and assumptions, including changes and developments in our business, competitive environment, political, economic, legal, and social conditions. Neither the Company nor its subsidiaries, directors, officers, advisors, or agents have any obligation, nor do they assume any obligation, to update the forward-looking statements contained in this press release to reflect new information, future events, or circumstances after the date of this press release, except as required by law.