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The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.
Merck & Co. has entered a global strategic oncology collaboration with Eisai to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and in combination with Merck’s anti-cancer biologic, Keytruda (pembrolizumab), for treating multiple cancer types, Merck announced in a March 7, 2018 press release. Keytruda is a blockbuster drug for Merck with $3.8 billion in total 2017 sales.
Under the agreement, Merck will pay Eisai an upfront payment of $300 million, up to $650 million for certain option rights through 2020, and $450 million as reimbursement for research and development expenses. In addition, Eisai is eligible to receive up to $385 million associated with the achievement of certain clinical and regulatory milestones and a maximum of up to $3.97 billion for the achievement of milestones associated with sales of Lenvima. Assuming the achievement of all development and commercial goals for all indications, the total amount of upfront, option, and regulatory and sales milestone payments has the potential to reach up to $5.76 billion.
Eisai will book Lenvima product sales globally, as monotherapy and in combination, and gross profits will be shared equally by Eisai and Merck. The two companies will also share equally in expenses incurred during co-development, including for studies evaluating Lenvima as monotherapy.
Lenvima is currently approved as monotherapy for treating thyroid cancer, as well as in combination with everolimus for treating renal cell carcinoma (RCC). Applications for regulatory approval of Lenvima monotherapy for treating hepatocellular carcinoma have been submitted in Japan, the United States, Europe, China, and other countries. In January 2018, the companies announced that FDA granted breakthrough therapy designation for the Lenvima/Keytruda combination in advanced and/or metastatic RCC.
Per the agreement, the companies will also jointly initiate new clinical studies evaluating the Lenvima/Keytruda combination to support 11 potential indications in six types of cancer- endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer, and melanoma-as well as a basket trial targeting multiple cancer types.
“Aiming to maximize the potential of [Lenvima] and expedite the creation of innovative treatments in this age of ‘Cancer Evolution,’ we have entered into this collaboration with Merck who developed the anti-PD-1 antibody [Keytruda],” commented Haruo Naito, representative corporate officer and CEO of Eisai, in a company press release. “By providing new treatment options including for refractory cancers with no hopes for a cure to date, we are striving to further contribute to increasing the benefits provided to patients and their families.”
“Together with Eisai, we aim to maximize the value of [Lenvima] for its current indications while jointly pursuing additional approvals in combination with [Keytruda] across a wide range of cancers,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in the press release. “There is strong scientific evidence supporting synergistic effects of [Keytruda] when used in combination with [Lenvima], and the companies have already received [b]reakthrough [t]herapy [d]esignation from [FDA] for the Keytruda/Lenvima combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”
Lenvima was discovered and developed in-house by Eisai. It is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, VEGFR1, VEGFR2, and VEGFR3, and fibroblast growth factor (FGF) receptors, FGFR1, FGFR2, FGFR3, and FGFR4 in addition to other pathway-related RTKs.
Lenvima is currently approved for treating refractory thyroid cancer in over 50 countries, including the US and Japan as well as countries in Europe and Asia. Eisai has also obtained approval for the agent in combination with everolimus as a second-line treatment for RCC in over 40 countries, including the US and in Europe. In Europe, the agent was launched under the brand name Kisplyx for RCC.
Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017), the US and Europe (July 2017), China (October 2017), Taiwan (December 2017), and other countries.
Keytruda is approved for treating melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial cancer, microsatellite instability-high cancer, and gastric cancer.
Source: Merck & Co.