\"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 http://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 prenatal vitamins.
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 http://www.sec.gov.