Advertisement
Novavax, Inc. believes its vaccine initiatives have the potential toimpact millions of people affected by infectious diseases each year bycreating novel vaccines that can be produced in a cost effective and timelymanner within the same scalable manufacturing platform worldwide.
Advertisement
VLPs are recombinant structures that mimic the size and shape of a virusbut lack genetic material and are therefore incapable of replication. Becausethey resemble actual infectious particles presenting proteins in the sameconformation as on the wild-type virus, they are able to induce potent immuneresponses. Novavax's VLP vaccine may be differentiated from other influenzavaccines in several ways. First, it includes three viral proteins(incorporated in the vaccine as three separate VLPs) important for inducing abroad immune response including two surface proteins, hemmaglutinin ("HA") andneuraminidase ("NA"), and a core matrix protein, M1. The HA protein inducesantibody that neutralizes or blocks the growth of the virus; NA inducesantibodies that prevent cell-to-cell transmission of virus down therespiratory tract, potentially reducing the severity of influenza disease; andcell mediated immune responses to M1 may lead to destruction of cells alreadyinfected. Further, the vaccine is made in cell culture rather than eggs, whichpermits an exact genetic match to the flu strains causing illness since thereis no requirement for adapting the vaccine to grow in eggs.
"We are proud to have our technology recognized by the Cleveland Clinic asone of the top ten medical innovations of 2009," said Dr. Rahul Singhvi,President and CEO of Novavax. "VLPs represent a very promising approach topreventing the spread of influenza as we recently demonstrated with theannouncement of favorable results in a Phase IIa human clinical trial of ourVLP based pandemic influenza vaccine.
Novavax's Novel Manufacturing Approach
Novavax's manufacturing process makes it possible to potentially produceand distribute a vaccine matched to a pandemic strain in time to interruptand/or halt a pandemic. Novavax's influenza VLPs are produced in insect cellculture, utilizing a manufacturing process that consists entirely ofdisposable, ready-to-use equipment. Current yields are 7 to 10 times higherthan that of traditional egg-based or mammalian cell culture manufacturing.Because the Novavax process involves recombinant technology and does notrequire a live influenza virus, vaccine can be manufactured within 10 to 12weeks of identification of a pandemic strain, approximately half the timerequired to manufacture egg-based vaccines. This new manufacturing approachpermits rapid commissioning at a fraction of the cost of traditional,egg-based manufacturing facilities. VLP-based vaccines may represent aneffective and affordable component of a pandemic solution for countries thatdo not currently have in-border pandemic vaccine production.
About Novavax
Novavax, Inc. is a clinical stage biotechnology company, creating novelvaccines to address a broad range of infectious diseases worldwide usingadvanced proprietary virus-like particle (VLP) technology. The Companyproduces these VLP based, potent, recombinant vaccines utilizing new, andefficient manufacturing approaches. Additional information about Novavax isavailable at http://www.novavax.com and in the Company's various filings withthe Securities and Exchange Commission.
Forward-Looking Statement
Statements herein relating to future development results and performance,conditions or strategies and other matters, including expectations regardingproduct and clinical developments, are forward-looking statements within themeaning of the Private Securities Litigation Reform Act. Novavax cautions thatthese forward-looking statements are subject to numerous assumptions, risksand uncertainties, which change over time. Factors that may cause actualresults to differ materially from the results discussed in the forward-lookingstatements or historical experience include risks relating to the early stageof Novavax's product candidates under development; current results may not bepredictive of future pandemic results, results of our seasonal influenzavaccine or any other vaccine that we may develop; further testing is requiredbefore regulatory approval can be applied for and the FDA may not approve avaccine even if further trial results are similar to those disclosedpreviously by the company; uncertainties relating to clinical trials,including possible delays in initiating or completing the trials and safetyand efficacy results; dependence on the efforts of third parties; competitionfor clinical resources and patient enrollment from drug candidates indevelopment by other companies with greater resources and visibility; andrisks that we may lack the financial resources and access to capital to fundour operations including further clinical trials. Further information on thefactors and risks that could affect Novavax's business, financial conditionsand 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 pressrelease, and Novavax assumes no duty to update forward-looking statements.
SOURCE Novavax, Inc.
