Merck & Co. licenses rights to NewLink Genetics' experimental Ebola vaccine rVSV-EBOV

Merck & Co. entered an exclusive global license agreement to develop NewLink Genetics' experimental Ebola vaccine rVSV-EBOV, the companies said Monday. The vaccine, originally developed by the Public Health Agency of Canada (PHAC), is currently being evaluated in Phase I trials.

"Merck is committed to applying our vaccine expertise to address important global health needs and, through our collaboration with NewLink, we hope to advance the public health response to this urgent international health priority," commented Julie Gerberding, president of Merck's vaccines division. The agreement gives Merck rights to rVSV-EBOV and any follow-on products, while PHAC will retain all non-commercial rights related to the product.

Under the deal, Merck will pay NewLink $30 million upfront and another $20 million once larger trials begin. In addition, NewLink will receive royalties on future sales, although Mark Feinberg, chief public health officer for Merck's vaccines unit, noted that these will be waived for doses sold to affected African countries. A report last week suggested that Merck and NewLink were in talks regarding the production of rVSV-EBOV.

In September, NewLink was granted clearance by the FDA to initiate Phase I trials of rVSV-EBOV, with the company later disclosing that studies of the vaccine started in the US. Further Phase I studies are also underway or planned to begin at centres in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network. Merck and NewLink noted that based on results of the trials, the US National Institutes of Health (NIH) could begin a Phase III study to evaluate the safety and efficacy of the vaccine early next year.

PHAC previously sent 800 vials of rVSV-EBOV to the World Health Organization for potential use in the ongoing Ebola outbreak, following guidance from an agency panel that it would be ethical to use experimental Ebola drugs and vaccines to treat patients during the ongoing outbreak under certain conditions. For related analysis, see ViewPoints: Congress looking to sweeten the pot for Ebola drugmakers and ViewPoints: WHO Director-General highlights need for governments to better incentivise industry to tackle communicable diseases.

Last month, Johnson & Johnson said that it plans to produce 1 million doses next year of an Ebola vaccine, which combines the company's AdVac technology and MVA-BN technology from Bavarian Nordic. Meanwhile, GlaxoSmithKline's is developing an experimental vaccine with the NIH, with clinical studies started earlier this year.

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