Novavax Reports Positive Pre-Clinical Study Results From Live Virus Challenge To Pandemic Flu Vaccine

Novavax Inc. said today
that it has received positive study results from a live virus challenge to
ferrets inoculated with its pandemic influenza vaccine, paving the way for
clinical trials to begin on schedule later this year.


In the study, ferrets were inoculated with the company's virus-like
particle (VLP) vaccine made from an Indonesian strain of H5N1 avian
influenza. The ferrets, which represent the most relevant influenza animal
model for humans, were then challenged with live H5N1 virus. All ferrets
that received the Novavax vaccine survived, even those that received the
lowest dose.



"These are our most important data to date," said Dr. Rick Bright,
Novavax's Vice President of Global Influenza Programs. "We are looking
forward to beginning our first clinical trial, which will be a major
milestone for Novavax."



According to the study, ferrets that received Novavax's H5N1 vaccine
were protected not only against the Indonesian strain of avian flu but also
were cross-protected against a separate strain originating in Vietnam.
Again, all ferrets that received the Novavax vaccine survived.



The ferret study was conducted in collaboration with the Southern
Research Institute of Birmingham, Ala., a facility approved for handling
highly lethal avian influenza viruses, and the University of Pittsburgh.



"We are on target to file our first vaccine investigational new drug
("IND") application by mid-year," said Novavax President and Chief
Executive Officer Dr. Rahul Singhvi. "Given the robust results we have now
received from the ferret challenge study, we are enthusiastic that we have
a valuable new vaccine candidate to take into clinic trials."



Ferrets infected with influenza experience symptoms similar to humans,
including runny noses, fevers, lethargy and weepy eyes. The ferret has
proved to be the most predictive animal model for success in human clinical
trials for influenza.



"Novavax's proprietary vaccine may be the very first VLP vaccine for
influenza to enter human clinical trials," Dr. Singhvi said. VLPs mimic the
three-dimensional structure of a virus but do not contain genetic material,
so they cannot replicate or cause infection. As VLPs maintain functional
properties of both influenza surface proteins (hemagglutinin and
neuraminidase), they likely trigger multiple arms of the immune system to
generate a broadly protective immune response.



About Novavax Inc.



Novavax Inc. (Nasdaq: NVAX) is committed to leading the global fight
against infectious disease by creating novel, highly potent vaccines that
are safer and more effective than current preventive options. Using the
company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant
technologies, Novavax is developing vaccines to protect against H5N1
pandemic influenza, seasonal flu and other viral diseases. Novavax's
particulate vaccines closely match disease-causing viruses while lacking
the genetic material to cause disease, which provides potential for greater
immune protection at lower doses than current vaccines. With an exclusive
portable manufacturing system that allows for rapid mass-production of
vaccines, Novavax is uniquely positioned to meet global public health
needs.



Forward-Looking Statements



Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters,
including expectations regarding future revenues, operating expenses, and
clinical developments are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act. Novavax cautions that these
forward-looking statements are subject to numerous assumptions, risks and
uncertainties, which change over time. Factors that may cause actual
results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks and
uncertainties, including the failure by Novavax to secure and maintain
relationships with collaborators; risks relating to the early stage of
Novavax's product candidates under development; uncertainties relating to
clinical trials; risks relating to the commercialization, if any, of
Novavax's proposed product candidates; dependence on the efforts of third
parties; dependence on intellectual property; competition for clinical
resources and patient enrollment from drug candidates in development by
other companies with greater resources and visibility, and risks that we
may lack the financial resources and access to capital to fund our
operations. Further information on the factors and risks that could affect
Novavax's business, financial conditions and results of operations, is
contained in Novavax's filings with the U.S. Securities and Exchange
Commission, which are available at sec. These
forward-looking statements speak only as of the date of this press release,
and Novavax assumes no duty to update forward- looking statements.


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