Lenvima is an orally available tyrosine kinase inhibitor discovered by Eisai.
The partnership will jointly develop and commercialize Lenvima as monotherapy and in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab).
Eisai will take the responsibility of Lenvima monotherapy product sales globally, while both firms will share gross profits equally for combination drug.
As per terms of the deal, Eisai will secure an upfront payment of $300m and up to $650m for certain option rights through 2020, as well as $450m as reimbursement for research and development expenses from Merck.
Eisai will also secure an additional $385m based on the achievement of certain clinical and regulatory milestones and maximum of up to $3.97bn for the achievement of milestones associated with sales of Lenvima.
The total amount of upfront, option and regulatory and sales milestone payments has the potential to reach up to $5.76bn assuming the achievement of all development and commercial goals for all indications.
The deal also includes the initiation of new clinical studies assessing the Lenvima/Keytruda combination to support 11 potential indications in six types of cancer, including endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma.
In addition, the firms will conduct basket trial targeting multiple cancer types.
The ongoing Eisai-sponsored phase 3 study is assessing separate combinations of Lenvima with Keytruda (pembrolizumab) or Lenvima with everolimus against chemotherapy alone for the treatment of RCC.
In January this year, Lenvima-Keytruda combination secured breakthrough therapy designation from the US Food and Drug Administration to treat advanced or metastatic RCC.
Eisai CEO and representative corporate officer Haruo Naito said: “Aiming to maximize the potential of LENVIMA and expedite the creation of innovative treatments in this age of "Cancer Evolution.”
Merck Research Laboratories president Roger Perlmutter said: “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.”