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 The Ebola GP Vaccine was well tolerated and elicited very high Ebola
antibody responses at all dose levels, the company said.
Novavax has the means to make millions of doses per week, and is in
"fairly advanced" talks over possible tie-ups with governmental and
non-governmental entities to develop the vaccine further, executives
told Reuters on Tuesday.
Potential partners include the Biomedical Advanced Research and
Development Authority (BARDA), a division of U.S. Department of
Health and Human Services, which Novavax is already working with to
develop influenza vaccines.
The Ebola epidemic in West Africa is the largest on record and has
killed more than 11,200 people.
But with vaccines from Bavarian Nordic, GlaxoSmithKline Plc and
Johnson & Johnson currently in mid-stage studies, analysts such as
JP Morgan's Cory Kasimov see only a limited commercial opportunity
for Novavax's version.
"We're not at the same stage as some of the other developers... but
what we have is an improvement over what's already being tested",
said Dr. Gregory Glenn, senior vice president of R&D.
Novavax is unsure when it will be able to proceed to the next stage
of development, but is aiming for approval under the "animal rule",
a comparatively shorter developmental pathway.
The U.S Food and Drug Administration's animal rule allows developers
to combine safety and immune system response data in humans with
data from experiments on animals in exceptional circumstances.
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If all goes well, the vaccine could be market ready in two to three
years, Glenn said.
Mid-stage data on company's lead experimental vaccine, which targets
respiratory syncytial virus (RSV), the most common cause of lower
respiratory tract infections in young American children, is expected
later this quarter.
The Ebola vaccine data builds confidence in other areas of Novavax's
pipeline, particularly the RSV program, which uses the same
technology, Kasimov said.
Gaithersburg, Maryland-based Novavax's stock rose as much as 5.5 pct
to a more than 13-year high of $13.12 on Tuesday, before reversing
course to trade down marginally.
The stock has risen about 51 percent since Feb. 12, when the company
said it had begun human trials of its Ebola
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