Merck and Ames, Iowa-based NewLink Genetics have entered into an exclusive worldwide license agreement to research, develop, manufacture and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.

The vaccine candidate, originally developed by the Public Health Agency of Canada (PHAC), is currently being evaluated in phase I clinical trials. Pending the results of ongoing phase I trials, the NIH plans to initiate, in early 2015, a large randomized, controlled phase III study to evaluate the safety and efficacy of the rVSV-EBOV vaccine and another investigational Ebola vaccine co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline.

Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine candidate is under an exclusive licensing arrangement with a wholly-owned subsidiary of NewLink Genetics. The PHAC retains non-commercial rights pertaining to the vaccine candidate.

Phase I clinical trials of the rVSV-EBOV vaccine now are underway at the Walter Reed Army Institute of Research and the NIAID at the NIH. Additional phase I studies are underway or planned to begin in the near future at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.