Tuesday, October 4, 2016

HHS/BARDA Awards Additional Contract To NewLink Genetics: Ebola Vaccine Marches Forward Toward Manufacturing Scale-Up...


While this firm additional $24 million -- plus kickers for another $51 million on milestone achievement -- is small potatoes to Kenilworth, it makes a very big difference to tiny NewLink. And it comes on top of an earlier $75 million from HHS -- this past Spring.

And so it is very good news in Ames. Even so, my unduly-busy graphic at right is intended to suggest that -- in fact -- "it takes a village" to conquer the Ebola vaccine puzzle -- from concept, to fully-scaled manufacturing. As we've long written, it is unlikely that a market price reflecting the full costs will be recoverable, so governmental and humanitarian funds will have to bridge that gap. Here is a bit -- from tonight's press release:

. . . .NewLink Genetics Corporation announced that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has issued a $24.8 million contract to a subsidiary of NewLink Genetics to support the advanced development of the investigational rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate, designated V920.

The new award includes an additional $51 million of contract options which may be exercised by BARDA. BARDA has previously awarded $76.8 million in contracts for development of V920. The new funding is in support of manufacturing facility readiness, manufacturing process qualification activities, and additional clinical trials to support regulatory approval of the V920 vaccine. . . .

In late 2014, Merck licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Merck is responsible for and involved in the research, development, manufacturing, distribution and regulatory efforts in support of V920. Clinical studies of the vaccine candidate are ongoing. . . .


It is almost certain that Merck will contribute real monetary value to this effort -- without a pecuniary profit in sight. And that is praise-worthy, indeed. Now you know.

नमस्ते

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