With a global focus on integrative neuroscience, (including neurology and psychiatric medicines); integrative oncology, (encompassing oncotherapy and supportive-care treatments); and vascular/immunological reaction, Japanese pharma company Eisai Co Ltd has announced that it is set to partner with Merck & Co.
The agreement will see the companies collaborate in the co-development and co-commercialisation of cancer drug LENVIMA. At present, the company has received approval to utilise the drug for refractory thyroid cancer in over 50 countries, including the US, Japan, Europe and Asia. The drug is also used in combination with everolimus for the treatment of patients with renal cell carcinoma (RCC), as well as with Merck’s immunotherapy drug KEYTRUDA.
Whilst Eisai will book LENVIMA product sales globally, and companies will share gross profits equally, as well as any expenses incurred during co-development. Applications for regulatory approval of LENVIMA monotherapy for the treatment of hepatocellular carcinoma have been submitted in Japan, the US, Europe, and China.
The companies will undertake clinical studies to look at how the combination of LENVIMA/KEYTRUDA will support 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, according to a press release.
The agreement will see Eisai initially receive $300mn from Merck, with up to $650mn for certain option rights. This is on top of $450mn for possible reimbursement for research and development expenses.
Additionally, Eisai is eligible to receive up to $385mn if it reaches certain clinical and regulatory milestones, with a maximum of up to $3.97bn associated with sales of LENVIMA. The total amount of upfront, option and regulatory and sales milestone payments would therefore the potential to reach up to $5.76bn.
"Aiming to maximise 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," explained Haruo Naito, Representative Corporate Officer and CEO of Eisai Co., Ltd.
"Together with Eisai, we aim to maximise the value of LENVIMA for its current indications while jointly pursuing additional approvals in combination with KEYTRUDA across a wide range of cancers," added Dr Roger M. Perlmutter, President, Merck Research Laboratories.
"There is strong scientific evidence supporting synergistic effects of KEYTRUDA when used in combination with LENVIMA, and the companies have already received Breakthrough Therapy Designation from the US. 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."