November 21, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Ames, Iowa-based NewLink Genetics, which owns the rights to an Ebola virus vaccine, is in talks with Merck & Co. over a possible production and distribution deal. Although the meeting itself has been confirmed, neither company is providing details.
“I don’t like commenting about agreements,” said NewLink CEO Charles Link to the Ottawa Citizen earlier this week, “until they’re finalized, but I have a pretty good feeling about it.”
In 2010, NewLink bought the rights to the vaccine from the Public Health Agency of Canada, who developed the vaccine. The deal price was $200,000. The vaccine is built of a single Ebola virus gene inserted into a vesicular stomatitis virus.
Scientists, researchers and politicians have been impatient with vaccine manufacturing delays. In Canada, the New Democratic Party has been pushing the Canadian government to revoke its licensing agreement with NewLink in order to free up the company to work with a larger pharmaceutical company. NewLink currently also has a manufacturing agreement with German company IDT Biologika GmbH.
Amir Attaran, a professor at the University of Ottawa, recently published a letter in the British medical journal The Lancet demanding that Canada withdraw from the agreement with NewLink.
“Canada needs to find a partner that is capable of replacing NewLink and Merck is an outstanding partner with the ability and the facilities to do so,” he said in a statement.
Merck has vaccine production technology called Vero, which would be able to more quickly scale up vaccine production. The company was previously working on its own Ebola vaccine until it sold off its Ebola vaccine research unit, Okairos AG, to GlaxoSmithKline in 2013. NewLink has indicated it could produce approximately 12 million doses of the vaccine by April 2015 with bigger vaccine production technology.
On Sept. 4, 2014, the U.S. Food and Drug Administration granted NewLink permission to start a Phase 1 clinical trial with their vaccine candidate, rVSV-ZEBOV-GP (VSV-EBOV, BPSC1001). NewLink is one of about twenty major companies working on either Ebola vaccines or possible drugs.
Despite the pressure and at least some hints that the company, for unspecified and unlikely reasons, is dragging its feet, Link said, “I think for the lay public it’s a little tougher for them to understand what’s behind the curtain in that development process.”
He pointed out that the vaccine is currently in five separate clinical trials on humans and in about a 10-day period, a team of staffers, working 16 to 18-hour days, were able to get FDA approval within four days. “I didn’t even know such a thing was possible,” Link said in a statement.
