ROCKVILLE, Md., May 13 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announces the first report of a vaccine protecting ferrets against the 2009 pandemic H1N1 virus has been published in the journal Vaccine
May 12, 2010 online issue. Scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, co-authored the scientific report.
Novavax produced a 2009 H1N1 influenza VLP vaccine and delivered it to the CDC in less than four (4) weeks following the April 24, 2009 announcement of the strain of the H1N1 influenza for vaccines. CDC scientists immunized ferrets with 3.75, 7.5, or 15.0 mcg dose of 2009 H1N1 influenza VLP vaccine or a placebo then boosted with a second dose after three (3) weeks. The H1N1 influenza VLP vaccine was highly immunogenic and all vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, which is considered a protective level of immunity. Vaccinated animals were challenged with nasal exposure of live H1N1 influenza virus isolated. Three (3) days post challenge, animals immunized with the 15 mcg dose of the H1N1 influenza VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. In contrast, control animals that received no vaccine were not protected from virus replication and became ill.
Dr. Rahul Singhvi, President and CEO of Novavax, stated: "This study demonstrated in real time the ability of our influenza VLP technology to respond quickly with an effective vaccine in the face of an influenza pandemic. We are pleased with the publication of this important study."
The published report concludes: "this study demonstrates that effective immunity to H1N1 pandemic virus can be achieved in ferrets by VLP vaccination, resulting in significant protection and viral clearance from the upper and lower respiratory tracts. Recombinant VLP vaccines are non-infectious and have advantages in safety and manufacturing. They circumvent problems like slow growth, unpredictable yields, and mutations during host adaption. Thus, rapid response immunization strategy for pandemic influenza outbreaks could include the preparation of VLP vaccine for prevention of disease in people."
About VLPs
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based, recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. In 2009, Novavax launched a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com .
Forward-Looking Statements
Statements herein relating to future performance, conditions or strategies and other matters, including expectations regarding clinical trials, release of new data, continued development of vaccines and potential differentiation, are forward-looking statements. 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 historical and current results that may not be predictive of future trial results for any vaccines that we are developing or may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if the results are similar or better than the results reported to date; uncertainties related to the initiation, enrollment, progress and completion of clinical trials; safety or efficacy issues not seen to date may be encountered; the immune systems of the elderly pose significant challenges for vaccines and our products may not be as efficacious in the elderly as they have been in test subjects to date; the company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; and the seasonal influenza vaccine industry is intensely competitive, making it difficult for our vaccine to have market success even if approved. 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 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.
SOURCE Novavax, Inc.
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Novavax produced a 2009 H1N1 influenza VLP vaccine and delivered it to the CDC in less than four (4) weeks following the April 24, 2009 announcement of the strain of the H1N1 influenza for vaccines. CDC scientists immunized ferrets with 3.75, 7.5, or 15.0 mcg dose of 2009 H1N1 influenza VLP vaccine or a placebo then boosted with a second dose after three (3) weeks. The H1N1 influenza VLP vaccine was highly immunogenic and all vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, which is considered a protective level of immunity. Vaccinated animals were challenged with nasal exposure of live H1N1 influenza virus isolated. Three (3) days post challenge, animals immunized with the 15 mcg dose of the H1N1 influenza VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. In contrast, control animals that received no vaccine were not protected from virus replication and became ill.
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Dr. Rahul Singhvi, President and CEO of Novavax, stated: "This study demonstrated in real time the ability of our influenza VLP technology to respond quickly with an effective vaccine in the face of an influenza pandemic. We are pleased with the publication of this important study."
The published report concludes: "this study demonstrates that effective immunity to H1N1 pandemic virus can be achieved in ferrets by VLP vaccination, resulting in significant protection and viral clearance from the upper and lower respiratory tracts. Recombinant VLP vaccines are non-infectious and have advantages in safety and manufacturing. They circumvent problems like slow growth, unpredictable yields, and mutations during host adaption. Thus, rapid response immunization strategy for pandemic influenza outbreaks could include the preparation of VLP vaccine for prevention of disease in people."
About VLPs
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based, recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. In 2009, Novavax launched a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com .
Forward-Looking Statements
Statements herein relating to future performance, conditions or strategies and other matters, including expectations regarding clinical trials, release of new data, continued development of vaccines and potential differentiation, are forward-looking statements. 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 historical and current results that may not be predictive of future trial results for any vaccines that we are developing or may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if the results are similar or better than the results reported to date; uncertainties related to the initiation, enrollment, progress and completion of clinical trials; safety or efficacy issues not seen to date may be encountered; the immune systems of the elderly pose significant challenges for vaccines and our products may not be as efficacious in the elderly as they have been in test subjects to date; the company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; and the seasonal influenza vaccine industry is intensely competitive, making it difficult for our vaccine to have market success even if approved. 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 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.
SOURCE Novavax, Inc.
