MALVERN, Pa., March 16 /PRNewswire-FirstCall/ -- Novavax, Inc.
(Nasdaq: NVAX), announced approval today from the National Institute of
Allergy and Infectious Diseases (NIAID), a component of the National
Institutes of Health (NIH), of an additional commitment of approximately $1.0
million to fund the third year of a 4 1/2 year research program. Novavax is
developing a novel HIV/AIDS virus-like particle (VLP) vaccine as part of an
NIH Integrated Preclinical/Clinical AIDS Vaccine Development Program comprised
of scientists from the University of Alabama at Birmingham, Emory University,
and Harvard Medical School. All three institutions are working with Novavax
in a collaboration to accelerate HIV/AIDS vaccine development.
Dr. Gale Smith, Vice President of Vaccine Development, explains, "We
believe the only realistic solution to the global HIV/AIDS pandemic is an
effective vaccine. Novavax is extremely pleased to be working with such an
acknowledged group of world leaders in developing a novel HIV/AIDS vaccine.
Our research is based on our insect cell technology for the production of
recombinant virus particles that mimic HIV-1, but without the risk of
infection." According to Dr. Beatrice Hahn, one of the principal
investigators at the University of Alabama at Birmingham, "Globally
circulating strains of HIV-1 are extraordinarily variable, and this diversity
poses a major obstacle to AIDS vaccine development. Currently, all candidate
vaccines are derived from contemporary HIV-1 isolates, often selected solely
based on availability. With VLP vaccines produced by Novavax, we are now
testing whether consensus immunogens can elicit broadly cross-reactive immune
responses and thus protect against a wide range HIV-1."
In the first two years of the program, Novavax developed a process to
manufacture HIV-1 VLPs from consensus sequences of the HIV-1 envelope
glycoprotein, the principle target for virus neutralization. These synthetic
genes were shown to be incorporated into particles that are structurally
similar to HIV-1. Scientists at UAB, Emory, and Harvard discovered that the
novel HIV/AIDS VLP vaccines induced a range of immune responses and antibodies
in small animals and non-human primates that neutralized both laboratory
strains and acute, contemporary HIV-1 isolates. The objectives for the team
during 2006 are to maximize efficiency of incorporation of the HIV-1 envelope
glycoprotein into particles. Novavax then plans to begin preparations for
human clinical trials of an improved HIV/AIDS VLP vaccine.
About HIV/AIDS Pandemic
According to a 2005 report from the World Health Organization (WHO),
HIV/AIDS has killed more 25 million people, making it one of the most
destructive epidemics in recorded history. HIV claimed the lives of more than
half a million children and about 3.1 million people overall in 2005. In the
United States alone, more than 40,000 become infected with HIV annually.
About Virus-Like Particle (VLP) Technology
Novavax's virus-like particle (VLP) vaccines use recombinant DNA
technology to produce antigenic structures that mimic a virus to produce a
protective immune response without the risk of infection or disease. Viral
proteins can self-assemble into VLPs when over-expressed in certain cells. The
use of VLP technology has already been proven with the success of the
hepatitis B vaccine and more recently with developmental human papillomavirus
vaccines. This is the first time that VLP technology has been applied to
create a potential HIV/AIDS vaccine and is the same technology Novavax is
using to produce influenza VLP vaccines that are readily adaptable and could
be scaled up to meet a surge in demand during a pandemic.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical
and vaccine products and technologies. The company's technology platforms
include the virus-like particle (VLP) manufacturing technology utilizing the
baculovirus expression system in insect cells, as well as novel vaccine
adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer
technologies. The company is developing a pandemic flu vaccine against the
H5N1, H9N2 and other avian influenza viruses and a season flu vaccine against
human influenza strains using its VLP and Novasome adjuvant technologies.
Novavax's drug delivery technologies include the micellar nanoparticle (MNP)
technology which is the basis for the development of its first FDA-approved
product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies
include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for
subcutaneous depot injection. The company has several products utilizing the
MNP technology in various stages of development.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's
intentions, hopes, beliefs, expectations, or predictions of the future are
forward-looking statements. Forward-looking statements include but are not
limited to statements regarding usage of cash, product sales, future product
development and related clinical trials and future research and development,
including FDA approval. Novavax's actual results could differ materially from
those expressed in such forward-looking statements. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual results, performance or achievements of the
Company, or industry results, to be materially different from those expressed
or implied by such forward-looking statements. Such factors include, among
other things, the 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 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 www.sec.gov.
SOURCE Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax Inc.,
+1-484-913-1213,
khamilton@novavax.com
