[Ip-health] Sanofi pulls out of Zika vaccine collaboration as feds gut its R&D contract | FiercePharma

Jamie Love james.love at keionline.org
Sat Sep 2 16:44:39 PDT 2017


​Eric Sagonowsky got this story late Friday afternoon.  ​(Better for the
reporter if you read this on the Fiercepharm web site).

​I'll post the Sanofi statement next. ​


http://www.fiercepharma.com/vaccines/contract-revamp-sanofi-s-zika-collab-u-s-government-to-wind-down

Eric Sagonowsky |
Sep 1, 2017 3:00pm

Sanofi didn't know it would be walking into a firestorm when it teamed up
with the U.S. Army to develop a Zika vaccine. But as the French drugmaker
was negotiating an exclusive license on the potential product, that's just
what happened—and now, the government is backing away from the
collaboration.

The decision means Sanofi won’t further develop or license the U.S. Army’s
promising Zika candidate, the company said Friday. The Department of Health
and Human Services’ development arm BARDA had committed $43 million in
research funding, with another $130 million available if the vaccine
advanced into later-stage testing.

The partners blamed Zika's "evolving epidemiology" for the change; after an
explosive early outbreak, the virus' spread has slowed. BARDA will continue
to fund a Zika-related study, according to the announcement, and the
partnership is headed to a point “where development would be indefinitely
paused but could be restarted if the epidemic re-emerges.”

As industry-watchers know, the collaboration had come under intense public
and political scrutiny this year as critics demanded pricing guarantees if
a commercial vaccine grew out of the taxpayer-funded research. After the
nonprofit Knowledge Ecology International raised the issue late last year,
a number of politicians and public officials joined in to call for pricing
assurances on the license.

Scientists with the U.S. Army originally developed the candidate.

It was a Federal Register notice about the exclusive license that touched
off the hot public debate, with a chorus of critics growing over the course
of the year. Sanofi executives defended the company on several occasions by
saying it was contributing its own development resources, risking money,
staff and time to pursue a project that might never yield a commercial
product.
​

  [snip]​

More recently, though, the virus’ spread in the U.S. and around the globe
has slowed. That fact, plus phase 1 results for the shot, made it
“necessary to substantially extend our projected vaccine development
timelines,” according to Friday’s announcement from the drugmaker. All of
that considered, Sanofi said it respects “BARDA’s decision to re-purpose
limited resources to meet their priorities.”

Vaccine experts have expressed frustration lately that the scientific
community has been reacting to recent deadly emergencies rather than
conducting early research ahead of an epidemic. Nonprofits and governments
recently came together to form the Coalition for Epidemic Preparedness
Innovations to try and improve on the vaccine R&D status quo.



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