Novavax Inc. (Nasdaq:
NVAX) -- Novavax Inc. said today its scientists have succeeded in making a
vaccine candidate designed to protect against the H5N1 clade 2 influenza
virus. Pre-clinical testing of the vaccine has already started.
"We believe this is the first vaccine to be made that targets the H5N1
clade 2 virus isolated from people in Indonesia who have been infected with
this mutated version of avian influenza," said Novavax President and Chief
Executive Officer Rahul Singhvi. "This is a very significant milestone for
Novavax and our proprietary virus-like particle (VLP) vaccine technology.
This demonstrates how rapidly we can respond by making a vaccine to protect
against emerging pathogens worldwide, compared to older egg-based
manufacturing methods."
The H5N1 avian influenza virus is rapidly evolving into antigenically
distinct clades, or families. H5N1 clade 1 flu viruses were identified in
Vietnam in 2003; by last winter, a second clade was identified in
Indonesia. Department of Health and Human Services Secretary Michael O.
Leavitt has said that the emergence of clade 2, which is the strain that is
spreading throughout Asia and parts of Europe, "dictates that we begin
developing a second pre-pandemic vaccine."
Leavitt and other global public health experts maintain that due to
H5N1's rapidly mutating nature, multiple vaccines will be needed to protect
against the many variations of the virus. The H5N1 vaccines currently in
clinical trials by many manufacturers and being stockpiled around the world
target only the clade 1 family of the virus.
"It is critical that we have vaccines that can protect against the
multiple variations of the virus and, most importantly, against the strains
of bird flu that are currently infecting and killing people," said Dr. Rick
Bright, Novavax's Vice President of Vaccine Development. "Our vaccine
technology allows us to create a vaccine directed at mutated viruses very
rapidly so that we can protect people from the newest circulating strains
of bird flu. We have also demonstrated in pre-clinical models that we are
able to generate protective levels of antibodies against influenza using a
single dose of VLP vaccine without the requirement of adding an adjuvant."
Novavax's new vaccine candidate uses the company's VLP technology,
which allows scientists to create a particle that is nearly identical to
the virus but does not have the virus's genetic material required for
replication or infection. When inoculated into the body, these particles
have the ability to attach to cells and trigger a natural immune response
-- sometimes from a single dose -- that is capable of protecting against
viral infection.
"We are eager to see if this vaccine is as effective in pre-clinical
models as we expect it to be," Dr. Bright said. Novavax has already seen
successful results from pre-clinical studies of its other pandemic and
seasonal influenza vaccines.
Pre-clinical testing of the H5N1 clade 2 vaccine has already been
initiated and is likely to take several months. "Once we collect and
analyze results of our pre-clinical tests, we will then be in a position to
take this timely vaccine into human clinical trials," Dr. Bright said.
About Novavax Inc.
Novavax Inc. 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.
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management's intentions, hopes, beliefs, expectations, or predictions of
the future are forward-looking statements. Forward-looking statements
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following: general economic and business conditions; ability to enter into
future collaborations with industry partners, competition; unexpected
changes in technologies and technological advances; ability to obtain
rights to technology; ability to obtain and enforce patents; ability to
commercialize and manufacture products; ability to establish and maintain
commercial-scale manufacturing capabilities; results of clinical studies;
progress of research and development activities; business abilities and
judgment of personnel; availability of qualified personnel; changes in, or
failure to comply with, governmental regulations; the ability to obtain
adequate financing in the future through product licensing, co-promotional
arrangements, public or private equity financing or otherwise; and other
factors referenced herein. Additional information is contained in Novavax's
annual report on Form 10K for the year ended December 31, 2005 and
quarterly report on Form 10Q for the quarter ended March 31, 2006
incorporated herein by reference. Statements made herein should be read in
conjunction with Novavax's annual and quarterly reports filed with the SEC.
Copies of these filings may be obtained by contacting Novavax at 508 Lapp
Road, Malvern, PA 19355, Tel 484-913-1200 or the SEC at sec.
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