DGAP-News: ICAAC Presentations Highlight Potential Protective Effects of Novavax' RSV Vaccine Candidate

DGAP-News: ICAAC Presentations Highlight Potential Protective Effects of 
Novavax' RSV Vaccine Candidate

Novavax, Inc. 

11.09.2013 14:30
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ROCKVILLE, Md., 2013-09-11 14:30 CEST (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company creating
novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported
positive findings from recent clinical and preclinical studies of its
respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in
poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in Denver, Colorado. 

In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and
older (Poster B-501d: 'RSV F Protein Vaccine Is Well-Tolerated and Immunogenic
in Elders'), Novavax' RSV F vaccine candidate was found to be compatible with
co-administration of an influenza vaccine, well-tolerated and elicited
increases in antibodies with potentially protective effects. In the study,
subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F
protein with or without an aluminum adjuvant, or placebo. All subjects received
trivalent inactivated influenza vaccine to mimic anticipated co-administration
of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum
anti-F IgG with titers of palivizumab-competing antibodies reaching 184ug/ml.
Changes in all measures of RSV antibodies, including microneutralization
assays, were positively correlated. The RSV F vaccine did not interfere with
responses to the influenza vaccine. Top-line results from this study were
reported previously by Novavax in July. 

In a separate preclinical study (Poster B-501a: 'Passive Immunization with RSV
F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A
Challenge'), investigators evaluated whether palivizumab-competing antibodies
induced by the RSV F vaccine could provide passive protection in a relevant
model. Palivizumab (Synagis(r)), a monoclonal antibody currently used to prevent
RSV disease, was previously studied in the cotton rat model, which provided
guidance for later licensing studies. 

'These presentations reflect our progress in defining the importance of the
palivizumab-like antibody and confirm that the RSV F vaccine induces promising
immune responses in the elderly population,' said Gregory Glenn, M.D., Senior
Vice President and Chief Medical Officer of Novavax. 'These two studies are
important because they demonstrate the potential of our vaccine candidate to
prevent a major public health problem in the elderly and also provide
protection to infants through passive maternal immunization. These are critical
unmet needs which we plan to address in later-stage efficacy studies.' 

Both posters are available under the 'Publications and Presentations' section
of the Novavax website at www.novavax.com. 

About RSV

RSV is a major respiratory pathogen in all humans regardless of age. In healthy
adults, RSV infections are generally mild to moderate in severity, but may be
more severe in infants and young children as well as the elderly and adults
with underlying chronic cardiac or pulmonary disease. It is estimated that
between 11-17,000 adults die of RSV infection annually in the U.S., with up to
180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a
common cause of childhood respiratory infection, with a disease burden of 64
million cases and causing approximately 160,000 deaths annually. Severe RSV
disease results in 3.4 million hospital admissions per year globally and
disproportionately affects infants below six months of age. Currently, there is
no approved RSV prophylactic vaccine available. 

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using Innovative proprietary recombinant protein
nanoparticle vaccine technology, as well as new and efficient manufacturing
approaches, the company produces vaccine candidates to efficiently and
effectively respond to both known and newly emergent diseases. Novavax is
involved in several international partnerships, including collaborations with
Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and
recently acquired Isconova AB, a leading vaccine adjuvant company located in
Sweden. Together, Novavax' network supports its global commercialization
strategy to create real and lasting change in the biopharmaceutical and
vaccinology fields. Additional information about Novavax is available on the
company's website, novavax.com. 

Forward-Looking Statements

Statements herein relating to the future of Novavax and its ongoing development
of its recombinant nanoparticle vaccine products are forward-looking
statements. Novavax cautions that these forward-looking statements are subject
to numerous risks and uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements. These risks and
uncertainties include those identified under the heading 'Risk Factors' in the
Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and
Form 10-Q for the period ended June 30, 2013, both filed with the Securities
and Exchange Commission (SEC). Investors are cautioned not to place
considerable reliance on forward-looking statements contained in this press
release and encouraged to read the Company's filings with the SEC, available at
www.sec.gov, for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of the date of
this document, and Novavax undertakes no obligation to update or revise any of
the statements. Novavax' business is subject to substantial risks and
uncertainties, including those referenced above and investors, potential
investors, and others should give careful consideration to these risks and
uncertainties. 


         CONTACT: Barclay Phillips
         SVP, Chief Financial Officer and Treasurer
         Novavax, Inc.
         240-268-2000
News Source: NASDAQ OMX



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Language:     English
Company:      Novavax, Inc.
              
               
              United States
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         US6700021040
WKN:          
 
End of Announcement                             DGAP News-Service
 
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