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$5.76bn deal puts Merck closer to Eisai and fast-growing Lenvima

The duo will start a series of clinical trials combining the multiple RTK inhibitor and Keytruda

Merck

Merck & Co likes the data coming out of trials combining its immuno-oncology drug Keytruda with Eisai’s Lenvima - and has signed a big deal to bind the two products closer together.

Merck (known as MSD outside the US and Canada) is paying $300m to Eisai - plus more than $5bn in potential milestones - to claim a share of the development and commercialisation rights for Lenvima (lenvatinib) and start a series of clinical trials in combination with Keytruda (pembrolizumab).

It’s a familiar approach for Merck’s chief executive Ken Frazier, coming after a similar $8.5bn deal with AstraZeneca involving PARP inhibitor Lynparza (olaparib), which also included a product buy-in and a commitment to studies of AZ’s drug alongside Keytruda.

Under the terms of the new deal, Eisai will book Lenvima sales - helped along by Merck’s commercial muscle - and the two companies will share profits on the drug. They will also split marketing costs as well as the bill for developing the drug for new indications.

Merck is in line for $650m in option right payments, $450m reimbursement of R&D expenses, and two blocks of $385m and $3.97bn for various regulatory and sales milestones, but as with the Lynparza deal will start to generate revenues straight away.

First approved in 2015 for refractory thyroid cancer, Lenvima has subsequently been given the nod as a second-line treatment for renal cell carcinoma in combination with everolimus and has been submitted for approval for hepatocellular carcinoma, a form of liver cancer. Eisai reported Lenvima sales of 9.6bn yen (around $90m) in the first six months of its current fiscal year, which ends on 31 March. It has predicted that Lenvima sales will top $1bn by 2021.

The prompt for the new deal seems to be encouraging results from the combination of Lenvima and Keytruda in the RCC cohort of the KEYNOTE-146 trial, with the duo achieving an overall response rate (reduction or stabilisation in tumour size) in 63% of patients after 24 weeks, with most patients (93%) seeing tumour regression. A second cohort of endometrial cancer patients had an ORR of 52% at the same timepoint.

“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,” said Merck’s head of R&D Roger Perlmutter.

He added there was “strong scientific evidence” behind the combination, pointing out that the duo has been awarded breakthrough status by the FDA for RCC.

Article by
Phil Taylor

8th March 2018

From: Sales

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