Monday, December 22, 2014

Right On Cue -- BARDA Funds Ebola Vaccine Candidate Phase Ib Study -- Additional $30 Million

As if to echo my theme of yesterday -- (almost prescient), seems Birdman's (and mine) -- BARDA, a US HHS (government) arm, has awarded a $30 million contract to NewLink & Merck, in scale up funding for the larger trials.

This is good news, and yet I am certain Merck was going to put on a full speed scale up -- out of internal corporate capital accounts, in any event. So this (again) just means Merck will be able to reduce its downstroke, here. Good for everyone. From GEN | News, then -- a bit (do go read it all):

. . . .The U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded a $30 million contract to a NewLink Genetics subsidiary toward supporting manufacturing and development activities of the Ebola vaccine candidate rVSV-EBOV the company is co-developing with Merck & Co., the companies said today. The grant—awarded to NewLink subsidiary BioProtection Systems — is intended to cover the cost of clinical development through a new 330-person Phase Ib study, the companies added.

“The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate,” Charles J. Link, Jr., M.D., NewLink’s founder, chairman, CEO, and CSO, said in a statement. “These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies. . . .”

As a side note, the press release indicates that Merck is now headquaretered in Kenilworth -- the old S-P HQ move must be going on this week and next. How times change. . . . my, my, my. . . . Onward!

1 comment:

Birdman said...

The story gets even better because according to a HHS Press Release there is also the possibility of $41 million options; possible total $71 million over the next 2 years :

"The other contract is with BioProtection Systems Corporation of Ames, Iowa, a wholly owned subsidiary of NewLink Genetics Corporation, for approximately 14 months and $30 million. It has options to extend the agreement 10 months and provide an additional $41 million."

Some of the $30 million is likely to go to Merck because the release states:

"In addition, BARDA will support development by both companies of vaccine formulations to improve productivity and stability, including a formulation similar to freeze-drying, so the vaccine does not have to be kept frozen. "

Some of the option money will likely be going to Merck because the release also states:

"Options under the contract include scale-up manufacturing from pilot scale used in clinical trials to commercial scale."

It is only logical that the process development and manufacturing occurs at Merck since they have the cell line and infrastructure for manufacturing well in place.