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|Novavax Receives Additional Government Funding for HIV/AIDS Vaccine Research|
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.