Eisai and Merck & Co. have partnered for worldwide co-development and co-commercialization of Lenvima (lenvatinib mesylate), a drug for treating thyroid cancer discovered by Eisai, in a deal worth up to $5.76 billion.

Under the agreement, Eisai and Merck & Co. will develop and commercialize Lenvima jointly, both as a monotherapy and in combination with Merck & Co.’s cancer drug, Keytruda (pembrolizumab). Lenvima is a solid-dose tyrosine kinase inhibitor, and Keytruda is an anti-programmed death-1 therapy indicated for treating various cancers: unresectable or metastatic melanoma; locally advanced or metastatic urothelial carcinoma; head and neck cancer; classical Hodgkin lymphoma, certain forms of gastric cancer, and microsatellite instability-high cancer. Keytruda had 2017 sales of $3.8 billion.

Under the deal, Merck & Co. will pay Eisai an upfront payment of $300 million and up to $650 million for certain option rights through 2020 as well as $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 achieving 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.

Lenvima is approved as a monotherapy for treating thyroid cancer as well as in combination with everolimus for treating patients with renal cell carcinoma (RCC) who have failed previous therapy. Applications for regulatory approval of Lenvima as a monotherapy for treating hepatocellular carcinoma have been submitted in the US, Japan, Europe, China, and other countries.

A Phase III study, sponsored by Eisai, is ongoing to evaluate separate combinations of Lenvima with Keytruda (pembrolizumab) or Lenvima with everolimus versus chemotherapy alone for treating RCC. In January 2018, Merck & Co. and Eisai announced that the US Food and Drug Administration 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.

Eisai will book Lenvima product sales globally, as a monotherapy and in combination, and Merck & Co. and Eisai will share gross profits equally. Expenses incurred during co-development, including for studies evaluating Lenvima as a monotherapy, will be shared equally by the two companies.

Source: Eisai and Merck & Co.