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NewLink Genetics gets some big league help on Ebola vaccine, enlists Merck

The small American company developing a made-in-Canada Ebola vaccine has just received some major league help.

And in the process, NewLink Genetics has earned itself a substantial payday, receiving a potential US$50 million for a licence it acquired from the Canadian government for just over $200,000 in 2010.

Pharma giant Merck has entered into an agreement with NewLink to develop the investigational Ebola vaccine, designed by scientists at Canada’s National Microbiology Laboratory in Winnipeg. The deal is worldwide and exclusive.

The deal will earn NewLink US$30 million in an upfront payment, to be followed by a milestone payment of US$20 million when trials to determine whether the vaccine is efficacious start early next year.

If the vaccine is successfully licensed, NewLink will receive royalties on future sales, though royalties will be waived for doses sold to affected African countries, said Merck Vaccine’s Chief Public Health Officer, Dr. Mark Feinberg.

Monday’s announcement culminated weeks of negotiations between the two companies and will be greeted with enthusiasm by parties hoping the vaccine can be used to contain the ongoing Ebola outbreak in West Africa.

“The WHO has a very productive collaboration with NewLink on the clinical development of rVSV-ZEBOV vaccine. We are delighted that the NewLink-Merck agreement will accelerate availability of a safe and effective Ebola vaccine even further,” Dr. Marie-Paule Kieny, the World Health Organization assistant deputy director who is spearheading the Ebola vaccine and drugs effort, said in an email.

There had been widespread concern that NewLink did not have the muscle or the experience to get the vaccine through testing and into use. The biotech, based in Ames, Iowa, does not have its own vaccine production facilities and has not yet brought a product through the gruelling regulatory process.

But in partnering with Merck on the Ebola vaccine, it has gained what it did not have. A multinational with operations in 140 countries, Merck is a major player in vaccine production.

In particular, Merck has substantial experience in the manufacture of live-virus vaccines grown in vero cells. The Canadian Ebola vaccine is a live virus vaccine grown in that production substrate.

“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,” Dr. Julie Gerberding, president of Merck Vaccines, said in a statement.

The agreement grants Merck the exclusive rights to the vaccine — known as rVSV-EBOV — as well as any follow on products.

It is expected if this vaccine works that vaccines using the same design might be made to protect against Marburg virus — a viral cousin of Ebola’s — as well as for other strains of Ebola and for other viral hemorrhage fever viruses, such as Lassa virus.

The current vaccine will only protect against the Ebola Zaire virus, the strain responsible for the current outbreak in West Africa. A future version might protect against multiple Ebola strains, in the way flu vaccines target three or four different families of flu viruses.

The vaccine, designed by scientists at Canada’s National Microbiology Laboratory in Winnipeg, is one of the two most advanced Ebola vaccines currently in play.

And of the two, it is the one scientists believe has the better chance of working in West Africa. It is thought the vaccine should be able to protect with a single dose, which is critical in countries where health-care systems are in tatters.

The other vaccine, made by GSK (formerly GlaxoSmithKline), is further along in testing. But it is feared that vaccine will require two doses — a priming dose and a boosting dose, perhaps with a different vaccine. The would be hugely challenging to deliver in the outbreak countries.

NewLink acquired the licence for the Canadian vaccine in 2010. At the time, there was no interest among Big Pharma players to develop Ebola vaccines, which may explain why the company was chosen and why the licensing fee was so low.

Ebola vaccines are unlikely to be money makers. The outbreaks happen sporadically and — before this one — in small numbers. The largest outbreak before this year involved 425 people. And outbreaks happen in countries that are among the poorest in the world, with the least capacity to pay per-dose prices that would cover the cost of development.

Some costs will likely be recouped by sales to countries like the United States, which may want to stockpile Ebola vaccine against perceived bioterror threats.

“We do not see this as a commercial opportunity,” Feinberg told The Canadian Press in an interview. He said Merck believes it can help with this project and feels it has an obligation to do so.

Under the agreement, the Public Health Agency of Canada retains non-commercial rights pertaining to the product.

“This vaccine is the result of years of hard work and innovation by Canadian scientists,” Health Minister Rona Ambrose said in the statement.

“We are pleased that this new alliance coupled with the clinical trials currently underway will further strengthen the possibility that the vaccine will make a difference in the global response to the Ebola outbreak.”