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NOVAVAX Announces Preclinical Study Results for a Respiratory Syncytial Virus ('RSV') Vaccine Candidate Directed Against the Fusion (F) Protein

Posted on: Friday, 27 February 2009, 07:00 CST

Preclinical Study Shows the Investigational RSV-F Virus-like Particle Vaccine Induced Neutralizing Antibodies and Protected Mice upon Challenge

ROCKVILLE, Md., Feb. 27 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced results from a preclinical study of a Respiratory Syncytial Virus ("RSV") vaccine candidate directed against the viral fusion (F) protein. The virus utilizes the F protein to fuse with cells in the respiratory tract and cause illness. Novavax's RSV-F VLPs were made using a proprietary matrix (i.e., "core") protein decorated with the human RSV F protein. The VLPs mimic the three-dimensional structure of RSV but cannot replicate and cause disease because they contain no genetic material.

In this study, mice were vaccinated with two injections of RSV-F VLPs (10 microgram dose; no adjuvant), RSV-F VLPs with different adjuvants, inactivated RSV, live RSV, or a placebo. Neutralizing antibody responses against RSV, which are important for preventing infection and lower respiratory illness, were highest in the "VLP plus adjuvant" group; responses with VLPs alone were higher than responses observed with either live or inactivated RSV immunization. The VLPs induced strong cell mediated immune responses with activation of CD8+ cytotoxic T-lymphocytes against the F protein, which are important for protection because they kill cells infected with RSV. The RSV-F VLP vaccine candidate also protected against RSV infection, reducing the quantity of RSV virus found in the lungs of immunized mice after a challenge with live virus.

A monoclonal antibody against F protein with annual sales of $500 million is available that protects against RSV-related hospitalizations in infants and young children at high risk of severe disease. However, several injections are required and the lifespan of the antibody has a limited duration. Therefore, a vaccine that induces long lasting protection against RSV-F is desired.

Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "We are very excited about these results, which open up a new avenue of clinical research using our VLP technology and further demonstrate the versatility of our VLP vaccine platform. We believe our approach holds great promise for preventing RSV disease and we look forward to advancing an RSV vaccine candidate into human clinical studies as soon as possible."

About Respiratory Syncytial Virus

RSV is the most commonly identified cause of lower respiratory tract infection in infants and young children with repeated infections causing moderate to severe cold-like symptoms throughout life. High risk individuals (including the elderly over age 65 years, people with cardiovascular disease and children less than four years of age) may also develop lower respiratory tract infections leading to bronchiolitis and pneumonia. It is estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the US and major European countries. In the United States alone there are 177,500 hospitalizations in high risk adults including the elderly over age 65, resulting in annual medicals costs exceeding $1 billion. In addition, there are up to 125,000 infants in the US who are hospitalized annually due to RSV. There is currently no approved vaccine for the prevention of RSV; the market potential for such a vaccine would be well in excess of $1 billion annually.

About Novavax

Novavax, Inc. is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary VLP technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information about Novavax is available at www.novavax.com and in the Company's various filings with the Securities and Exchange Commission.

Forward Looking Statement

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, safety, efficacy and potency of our vaccines, and supply availability are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to commencing clinical trials and their outcome; risks relating to the supply and commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrolment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

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SOURCE Novavax, Inc.

Source: PR Newswire

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