Cleveland Clinic Recognizes New Strategies For Creating Vaccines For Avian Flu As A Top Ten Medical Innovation For 2009

Main Category: Bird Flu / Avian Flu
Also Included In: Immune System / Vaccines
Article Date: 14 Nov 2008 - 0:00 PST

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Novavax, Inc. (Nasdaq: NVAX) announced that its strategy for treating avian flu through genetically-engineered virus-like particles (VLPs) was ranked as a Top Ten Innovation at Cleveland Clinic 6th Annual Medical Innovation Summit.

Novavax, Inc. believes its vaccine initiatives have the potential to impact millions of people affected by infectious diseases each year by creating novel vaccines that can be produced in a cost effective and timely manner within the same scalable manufacturing platform worldwide.

VLPs are recombinant structures that mimic the size and shape of a virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to induce potent immune responses. Novavax's VLP vaccine may be differentiated from other influenza vaccines in several ways. First, it includes three viral proteins (incorporated in the vaccine as three separate VLPs) important for inducing a broad immune response including two surface proteins, hemmaglutinin ("HA") and neuraminidase ("NA"), and a core matrix protein, M1. The HA protein induces antibody that neutralizes or blocks the growth of the virus; NA induces antibodies that prevent cell-to-cell transmission of virus down the respiratory tract, potentially reducing the severity of influenza disease; and cell mediated immune responses to M1 may lead to destruction of cells already infected. Further, the vaccine is made in cell culture rather than eggs, which permits an exact genetic match to the flu strains causing illness since there is no requirement for adapting the vaccine to grow in eggs.

"We are proud to have our technology recognized by the Cleveland Clinic as one of the top ten medical innovations of 2009," said Dr. Rahul Singhvi, President and CEO of Novavax. "VLPs represent a very promising approach to preventing the spread of influenza as we recently demonstrated with the announcement of favorable results in a Phase IIa human clinical trial of our VLP based pandemic influenza vaccine.

Novavax's Novel Manufacturing Approach

Novavax's manufacturing process makes it possible to potentially produce and distribute a vaccine matched to a pandemic strain in time to interrupt and/or halt a pandemic. Novavax's influenza VLPs are produced in insect cell culture, utilizing a manufacturing process that consists entirely of disposable, ready-to-use equipment. Current yields are 7 to 10 times higher than that of traditional egg-based or mammalian cell culture manufacturing. Because the Novavax process involves recombinant technology and does not require a live influenza virus, vaccine can be manufactured within 10 to 12 weeks of identification of a pandemic strain, approximately half the time required to manufacture egg-based vaccines. This new manufacturing approach permits rapid commissioning at a fraction of the cost of traditional, egg-based manufacturing facilities. VLP-based vaccines may represent an effective and affordable component of a pandemic solution for countries that do not currently have in-border pandemic vaccine production.

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 virus-like particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. Additional information about Novavax is available at http://www.novavax.com and in the Company's various filings with the Securities and Exchange Commission.

Forward Looking Statement

Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments, 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 relating to the early stage of Novavax's product candidates under development; current results may not be predictive of future pandemic results, results of our seasonal influenza vaccine or any other vaccine that we may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if further trial results are similar to those disclosed previously by the company; uncertainties relating to clinical trials, including possible delays in initiating or completing the trials and safety and efficacy results; dependence on the efforts of third parties; competition for clinical resources and patient enrollment 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 including further clinical trials. 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.

Novavax, Inc.
http://www.novavax.com