NASDAQ symbol: NVAX
MALVERN, PA, Aug 25, 2005 /PRNewswire-FirstCall via COMTEX/ -- Novavax, Inc.
(Nasdaq: NVAX), a specialty biopharmaceutical company, today reported
preclinical results on the Company's novel Virus-Like Particle (VLP) influenza
vaccine. Novavax's biological group led by Dr. Gale Smith, together with Dr.
Tumpey and Dr. Bu from the Centers for Disease Control and Prevention,
published the detailed results in the August 15 online edition of the journal
Vaccine. The study demonstrates that a H9N2 influenza virus (avian flu)
vaccine produced with the Company's proprietary VLP technology is effective in
protecting animals when challenged with live H9N2 influenza virus.
"Our VLP technology, based on a scalable process with short production
lead times, offers an attractive alternative to the existing egg-dependent and
the newer cell-based methods for the manufacture of influenza vaccine and
other urgently needed vaccines. These advantages address the challenge of
producing large quantities of a pandemic flu vaccine within a short
timeframe," said Rahul Singhvi, President and CEO of Novavax. "This
publication demonstrates the value of Novavax's VLP vaccine pipeline. Our plan
is to advance our VLP technology into clinical trials with both pandemic and
seasonal versions of influenza VLP vaccines."
The work, published in the peer-reviewed journal Vaccine, was completed
in collaboration with the Center for Disease Control and Prevention. It
involved VLP vaccines constructed from proteins (HA, NA, and M1) produced from
genes cloned from avian H9N2 influenza virus by Novavax at the CDC. The
animals, vaccinated with a low dose of VLP without the addition of an
adjuvant, developed antibodies after the first subcutaneous immunization.
Immune responses increased after booster inoculation, and were shown to be
protective when challenged with the H9N2 influenza virus. To view the article
visit the Company's website at www.novavax.com.
"VLP vaccines depend on human immune mechanisms which are highly
effective at recognizing and mounting a response against particles the general
size and structure of viruses. The nanometer size and structural similarity of
VLP vaccines to a live virus enable efficient interaction at a cellular level.
VLP vaccines safely imitate whole virus vaccines and can never cause infection
since they do not contain genetic material from a virus. Our VLP vaccines for
flu, HIV/AIDS and other diseases are proving to be effective at stimulating
immunity even at low doses and without the addition of chemical adjuvants,"
said Dr. Gale Smith, Vice President Vaccine Development of Novavax.
The study was supported in part by a grant from the National Institute of
Allergy and Infectious Disease (NIAID) of the National Institutes of Health
(NIH) to develop avian flu vaccines using VLP technology. The Company expects
to continue working on its Avian Flu vaccine program and produce vaccine for
testing in human clinical trials. Significant progress is also being made with
VLP vaccines for AIDS and SARS with the support of grants from the NIH.
About Avian Flu Viruses
Avian flu viruses are gaining worldwide attention as a strain of the
virus has spread in migratory birds throughout most of Asia and Russia causing
millions of birds to die from infection. Concern is growing of a potential
pandemic if the virus was to become easily transmitted from human to human.
There is no means to predict which specific strain of avian flu will prove
capable of human to human transmission. For this reason new vaccine production
methods that are rapid, not dependent on limited supplies of fertilized eggs,
and ideally effective at standard doses are needed to assist health
authorities in meeting the challenge of the demand for a pandemic vaccine.
About Virus-Like Particle (VLP) Technology
Novavax's VLP technology uses recombinant protein technology to imitate
the important three dimensional structures of the influenza virus to provide
protection without the risk of infection or disease and without the addition
of chemical adjuvants. Novavax's proprietary production technology lowers the
cost and eliminates the labor intensive nature of the traditional egg based
process by using insect cells. The VLP technology produces safe and effective
vaccine products through an aseptic process that reduces contamination risk
and produces high, cost-effective yields. A key advantage of the technology is
the ability to rapidly respond to emerging threats or new strains. A VLP
vaccine can be engineered within a few weeks of the discovery of a new virus,
after the publication of its DNA sequence data by the government. VLP vaccines
can be manufactured within a three day production process in an insect cell
system widely used in the biotechnology industry.
About Novavax, Inc.
Novavax, Inc. is a specialty biopharmaceutical company focused on the
research, development and commercialization of products utilizing its
proprietary drug delivery and biological technologies for large and growing
markets. Novavax currently distributes a line of prescription pharmaceutical
products, including its topical emulsion for estrogen therapy ESTRASORB, and
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, including
an ESTRASORB(R) licensing agreement; 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, 2004 and quarterly reports on Form 10Q for the
quarters ended March 31, 2005 and June 30, 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.
INVESTOR RELATIONS: Dr. Rahul Singhvi, President and CEO, Novavax Inc.,
Tel: (484) 913-1200,