DGAP-News: Novavax, Inc. /
Novavax Announces Continuation of RSV Vaccine Partnership With PATH

13.01.2014 / 14:00

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ROCKVILLE, Md., 2014-01-13 14:00 CET (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX) announced the continuation of their partnership
with PATH to develop Novavax' RSV (respiratory syncytial virus) vaccine for
maternal immunization. Under this amendment, PATH will provide Novavax
approximately $3.5 million in funding to support the ongoing Phase II
dose-confirmatory clinical trial in women of childbearing age, initiated in
October 2013. Under this partnership, Novavax and PATH will also initiate
planning activities for clinical development of the vaccine in low-resource
countries. 

Data from the ongoing Phase II clinical trial will provide additional evidence
of the vaccine candidate's safety and establish the appropriate dose to be used
in a follow-on clinical trial in pregnant women. By immunizing pregnant women,
Novavax believes that high levels of protective maternal RSV antibodies will be
transferred to their offspring through the placenta before birth, providing
protection in early infancy when RSV infection is most dangerous. 

Under this partnership, PATH and Novavax may elect to continue to collaborate
on additional clinical trials to further develop Novavax' RSV vaccine for
maternal immunization in low-resource countries. Novavax retains global rights
to commercialize the product and will support PATH in its goal to make the
product affordable and available in low-resource countries. 

'PATH, an internationally recognized innovative global health organization,
continues to support a key portion of the development expenses for our RSV
vaccine candidate. We are gratified by PATH's continued funding of this vaccine
development program, which has the potential to dramatically improve pediatric
health worldwide,' said Stanley C. Erck, President and CEO of Novavax. 

'We are pleased to be working with Novavax to support the development of a
maternal RSV vaccine that has the potential to protect infants in low-resource
countries during the critical early months of life,' said Dr. John Donnelly,
director of PATH's RSV vaccine project. 

About RSV

Respiratory syncytial virus (RSV) is one of the most common causes of lower
respiratory tract infection among young children, both globally and in the
United States. The majority of cases of severe RSV disease occur in otherwise
healthy children. It is estimated that there are 64 million cases of RSV
disease worldwide each year, resulting in 160,000 deaths. In the U.S., RSV
causes as many as 172,000 annual hospitalizations among children younger than 5
years old, with the vast majority of these occurring in infants less than six
months of age. Maternal immunization for the protection of young infants
against infectious diseases has been successfully employed to eliminate 92% of
neonatal tetanus cases globally, and in the U.S. is currently used to prevent
whooping cough and influenza. Currently, there is no approved vaccine against
RSV. 

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, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Additional information about Novavax is available on the company's website,
novavax.com. 

About PATH

PATH is an international nonprofit organization that transforms global health
through innovation. We take an entrepreneurial approach to developing and
delivering high-impact, low-cost solutions, from lifesaving vaccines, drugs,
diagnostics, and devices to collaborative programs with communities. Through
our work in more than 70 countries, PATH and our partners empower people to
achieve their full potential. For more information, please visit www.path.org. 

Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant 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 September 30, 2013, both filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on
the forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at 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 we undertake no obligation to update or revise any of the statements. Our
business is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties. 


         CONTACT: Barclay A. 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  
ISIN:        US6700021040   
 
 
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