Merck & Co. agreed to pay $300 million upfront as part of a deal to jointly develop and market Eisai's tyrosine kinase inhibitor Lenvima (lenvatinib mesylate) for multiple cancer types, the companies announced. Under the agreement, the drugmakers will develop Lenvima both as monotherapy and in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab).
Eisai's oral drug is currently approved as monotherapy for use in the treatment of thyroid cancer, as well as in combination with everolimus for the treatment of patients with renal cell carcinoma (RCC) who have failed previous therapy. Meanwhile, a late-stage study is ongoing to evaluate Lenvima with Keytruda versus chemotherapy alone for the treatment of RCC.
Roger Perlmutter, president of Merck Research Laboratories, commented "there is strong scientific evidence supporting synergistic effects of Keytruda when used in combination with Lenvima." Results presented in September last year showed that in 30 patients with metastatic RCC, the combination of Lenvima and Keytruda led to an objective response rate of 63 percent, with tumour regression observed in 93 percent of subjects.
"We were very impressed with results we obtained on combinations with Lenvima," Perlmutter said, adding "it makes sense...to try to develop the drug to the full extent possible as monotherapy and in combination with Keytruda." Merck and Eisai will jointly initiate studies evaluating the combination of Lenvima and Keytruda to support 11 potential indications in endometrial cancer, non-small-cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma.
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Along with the upfront payment, Merck will pay Eisai up to $650 million for certain option rights through 2020 on Lenvima, as well as $450 million as reimbursement for R&D expenses. In addition, Eisai is eligible to receive up to $385 million linked to certain clinical and regulatory milestones, as well as a maximum of nearly $4 billion for the achievement of milestones associated with sales of Lenvima. According to the companies, Eisai will book global Lenvima product sales, as monotherapy and in combination, with the two parties equally sharing gross profits.
Last year, Merck entered a similar deal potentially worth up to $8.5 billion to jointly develop AstraZeneca's PARP inhibitor Lynparza (olaparib) for multiple cancer types, both as monotherapy and in combination with other drugs, including Keytruda and the UK drugmaker's PD-L1 medicine Imfinzi (durvalumab).
Commenting on the latest deal, Frank Clyburn, head of Merck's commercial oncology business, said "like the Lynparza deal with AstraZeneca, this starts to really broaden out Merck's portfolio," adding that "Merck will start to receive revenue right away."
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