[Ip-health] FiercePharma: U.S. Army's planned Zika vax license to Sanofi raises nonprofit's ire

Zack Struver zack.struver at keionline.org
Tue Jan 10 10:35:29 PST 2017


U.S. Army's planned Zika vax license to Sanofi raises nonprofit's ire

by Eric Sagonowsky | Jan 10, 2017 9:54am

The U.S. Army's decision to transfer a Zika vaccine candidate's license to
development partner Sanofi has prompted protest from a nonprofit worried
about the legality of the plan and the product's future pricing.

Developed by Army scientists, the Zika purified inactivated virus vaccine
is currently in phase 1 testing at the Walter Reed Army Institute of
Research and the National Institutes of Health. Under a development
agreement with Sanofi, the pharma is to prep for larger-scale development
and manufacturing.

But Knowledge Ecology International has some concerns about the Army’s plan
to transfer the vaccine license to the company. It's worried, for one,
“about how the price of the vaccine may affect access.” The Army disclosed
its plan Dec. 9 in a Federal Register post.

Additionally, KEI believes the license would “not be legal” because it
isn’t necessary to motivate the pharma company to develop the vaccine
through to the market; so far, the candidate has been supported by
“extensive government subsidies,” KEI argues.

If the vaccine were to earn approval, Sanofi would win a priority review
voucher from the FDA, KEI says. Those vouchers have been growing in value
in recent years. One sold for $350 million in August 2015. According to a
draft KEI statement, that is a “valuable incentive in itself.”

A Sanofi spokesperson said the company is "sharing inherent risks" by
partnering with the government on Zika, adding that, even with tax-funded
support, the drug giant is "still assuming financial and opportunity risks
by devoting human and other resources to this project that otherwise would
be working on other projects."

"We have been informed of the objections and welcome the opportunity to
respond," according to the spokesperson.

Sanofi says it has "modeled various scenarios" for the virus and its
prevalence, adding that the "nature of the epidemiology and spread of the
virus will impact the degree of profitability." A spokesperson said it's
"way too early" to talk about pricing or when the vaccine candidate might
be available.

In seeking to learn more about the plan, KEI requested information about
the vaccine's related intellectual property, the licensing agreement and
the amount of government funding the project has received. The Army
declined, KEI says, and the nonprofit is objecting to the “lack of
transparency” in the process. After hearing from KEI, the Army extended the
comment period about its plan to Jan. 23, a KEI representative said.

Sanofi partnered with the U.S. Army on the technology in July 2015 and
later won a $43 million government grant to support the work. That money
covers development through phase 2, and Sanofi said it might ask for phase
3 or other support "if all goes well" with the program. With many service
members deployed in endemic areas, work on the vaccine is part of the
Army's response to Zika.

The tie-up is one of several inked by government agencies in response to
the Zika outbreak. Shortly after Sanofi signed on with the Army,
GlaxoSmithKline partnered with the NIH to tackle Zika with technology
called self-amplifying mRNA, or SAM. Takeda later entered the vaccine hunt
with a $312 million deal with the U.S. government's Biomedical Advanced
Research and Development Authority (BARDA).

An R&D path spanning government and industry is not uncommon, as many top
drugs start out in tax-funded labs and eventually make their way to
biopharma companies for further development.

Industry-watchers have said a Zika vaccine could be a lucrative prospect
even outside countries where the disease is endemic, thanks to
international travelers able to pay a high price for protection. In
addition, campaigns in endemic areas might target girls to protect against
the virus and its associated birth defects.

The Army didn't immediately respond to a request for comment.

According to its website, the nonprofit KEI "searches for better outcomes,
including new solutions, to the management of knowledge resources."

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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