Novavax, Inc.
(Nasdaq: NVAX) announced that its strategy for treating avian flu
through genetically-engineered virus-like particles (VLPs) was ranked as a
Top Ten Innovation at Cleveland Clinic 6th Annual Medical Innovation
Summit.
Novavax, Inc. believes its vaccine initiatives have the potential to
impact millions of people affected by infectious diseases each year by
creating novel vaccines that can be produced in a cost effective and timely
manner within the same scalable manufacturing platform worldwide.
VLPs are recombinant structures that mimic the size and shape of a
virus but lack genetic material and are therefore incapable of replication.
Because they resemble actual infectious particles presenting proteins in
the same conformation as on the wild-type virus, they are able to induce
potent immune responses. Novavax's VLP vaccine may be differentiated from
other influenza vaccines in several ways. First, it includes three viral
proteins (incorporated in the vaccine as three separate VLPs) important for
inducing a broad immune response including two surface proteins,
hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein,
M1. The HA protein induces antibody that neutralizes or blocks the growth
of the virus; NA induces antibodies that prevent cell-to-cell transmission
of virus down the respiratory tract, potentially reducing the severity of
influenza disease; and cell mediated immune responses to M1 may lead to
destruction of cells already infected. Further, the vaccine is made in cell
culture rather than eggs, which permits an exact genetic match to the flu
strains causing illness since there is no requirement for adapting the
vaccine to grow in eggs.
"We are proud to have our technology recognized by the Cleveland Clinic
as one of the top ten medical innovations of 2009," said Dr. Rahul Singhvi,
President and CEO of Novavax. "VLPs represent a very promising approach to
preventing the spread of influenza as we recently demonstrated with the
announcement of favorable results in a Phase IIa human clinical trial of
our VLP based pandemic influenza vaccine.
Novavax's Novel Manufacturing Approach
Novavax's manufacturing process makes it possible to potentially
produce and distribute a vaccine matched to a pandemic strain in time to
interrupt and/or halt a pandemic. Novavax's influenza VLPs are produced in
insect cell culture, utilizing a manufacturing process that consists
entirely of disposable, ready-to-use equipment. Current yields are 7 to 10
times higher than that of traditional egg-based or mammalian cell culture
manufacturing. Because the Novavax process involves recombinant technology
and does not require a live influenza virus, vaccine can be manufactured
within 10 to 12 weeks of identification of a pandemic strain, approximately
half the time required to manufacture egg-based vaccines. This new
manufacturing approach permits rapid commissioning at a fraction of the
cost of traditional, egg-based manufacturing facilities. VLP-based vaccines
may represent an effective and affordable component of a pandemic solution
for countries that do not currently have in-border pandemic vaccine
production.
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novel
vaccines to address a broad range of infectious diseases worldwide using
advanced proprietary virus-like particle (VLP) technology. The Company
produces these VLP based, potent, recombinant vaccines utilizing new, and
efficient manufacturing approaches. Additional information about Novavax is
available at novavax and in the Company's various filings
with the Securities and Exchange Commission.
Forward Looking Statement
Statements herein relating to future development results and
performance, conditions or strategies and other matters, including
expectations regarding product 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 relating to the early stage of
Novavax's product candidates under development; current results may not be
predictive of future pandemic results, results of our seasonal influenza
vaccine or any other vaccine that we may develop; further testing is
required before regulatory approval can be applied for and the FDA may not
approve a vaccine even if further trial results are similar to those
disclosed previously by the company; uncertainties relating to clinical
trials, including possible delays in initiating or completing the trials
and safety and efficacy results; dependence on the efforts of third
parties; 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 including further clinical trials.
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.
Novavax, Inc.
novavax
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