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The company believes its vaccine initiatives have the potential to impactmillions of people affected by infectious diseases each year by creating novelvaccines that can be produced in a cost effective and timely manner within thesame scalable manufacturing platform worldwide.
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Novavax's manufacturing process makes it possible to rapidly produce aninfluenza vaccine that contains strains that are an exact genetic match to thestrains circulating in the country or region causing influenza disease.Novavax's influenza VLPs are produced through recombinant technology in insectcell culture, utilizing a manufacturing process that will consist entirely ofdisposable, ready-to-use equipment. Current yields are 7 to 10 times higherthan those of traditional egg-based or mammalian cell culture manufacturing.Because the Novavax process involves recombinant technology and does notrequire a live influenza virus, a matched vaccine for avian or seasonalinfluenza can be manufactured within 12 weeks of identification by the Centersfor Disease Control and Prevention, which is approximately half the timerequired to manufacture egg-based vaccines.
Novavax has developed a VLP based vaccine candidate against H5N1 avianinfluenza that has completed a Phase IIa clinical trial. The studydemonstrated that the VLP vaccine is well tolerated and immunogenic and can beproduced rapidly to supply vaccine against an emerging pandemic strain. Thecompany has also commenced a Phase II trial in healthy adults for its seasonalinfluenza vaccine candidate.
About the Clinton Global Initiative (CGI)
Established in 2005 as a project of the non-partisan William J. ClintonFoundation, the Clinton Global Initiative (CGI) convenes global leaders todevise and implement innovative solutions to some of the world's most pressingchallenges. Since 2005, CGI members have made nearly 1,000 Commitments toAction valued at upwards of $30 billion to improve more than 200 million livesin over 150 countries around the world. Through past Annual Meetings, CGI hasbrought together more than 80 current and former heads of state, hundreds oftop CEOs and nonprofit leaders, major philanthropists, and 10 of the last 16Nobel Peace Prize laureates.
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;dependence on the efforts of third parties; competition for clinical resourcesand patient enrollment from drug candidates in development by other companieswith greater resources and visibility; and risks that we may lack thefinancial resources and access to capital to fund our operations includingfurther clinical trials. Further information on the factors and risks thatcould affect Novavax's business, financial conditions and results ofoperations, is contained in Novavax's filings with the U.S. Securities andExchange Commission, which are available at http://www.sec.gov. Theseforward-looking statements speak only as of the date of this press release,and Novavax assumes no duty to update forward-looking statements.
SOURCE Novavax, Inc.
