Novavax Announces Grant of Up to $89 Million to Support Development of RSV F Vaccine to Protect Infants Via Maternal Immunization
(Thomson Reuters ONE) -
Bill & Melinda Gates Foundation to Support Development of the RSV F Vaccine
Program
GAITHERSBURG, Md., Sept. 29, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced it has been awarded a grant of up to $89 million from
the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine
Phase 3 clinical trial in pregnant women, planned to initiate during the first
quarter of 2016. This grant will also support regulatory licensing efforts,
providing a path to WHO prequalification. Upon licensure, Novavax has agreed to
make the RSV F Vaccine affordable and accessible to people in the developing
world.
"Respiratory syncytial virus (RSV) is the leading cause of pneumonia in infants,
and currently there are no affordable approaches to protecting children in the
developing world from this viral disease," said Dr. Keith Klugman, Director of
the Bill & Melinda Gates Foundation's Pneumonia Program. "Maternal immunization
may provide protective antibodies to infants during the first few months of
life, and we hope this vaccine will protect infants from this disease to help
them live healthy, productive lives."
"Along with today's announcement of top-line data from the Phase 2 clinical
trial of our RSV F Vaccine with the goal to protect infants via maternal
immunization, we are very gratified to receive the support of the Bill & Melinda
Gates Foundation to improve the health of infants throughout the world," said
Stanley C. Erck, President and CEO. "Our groundbreaking Phase 2 results in both
maternal and older adult target populations, underscore the promise of our RSV F
Vaccine programs. We look forward to carrying our recent momentum into the
fourth quarter as we prepare to initiate two pivotal Phase 3 trials of our RSV F
Vaccine."
A fact sheet on maternal immunization is available at the Novavax
website,http://novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9
x10.pdf
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory
tract infections and the leading viral cause of severe lower respiratory tract
disease in infants and young children worldwide, with estimated annual infection
and mortality rates of 64 million and 160,000, respectively(1). In the US, RSV
is the leading cause of hospitalization of infants(2). Despite the induction of
post-infection immunity, repeat infection and lifelong susceptibility to RSV is
common(3,4). Currently, there is no approved RSV vaccine available. Palivizumab
is a monoclonal antibody, licensed and sold by MedImmune as Synagis(®), that
targets the RSV F protein and is used for prophylaxis against RSV disease in
high risk infants.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global health through
safe and effective vaccines. Additional information about Novavax is available
on the company's website, novavax.com.
References:
1. Nair, H. et al. Global burden of acute lower respiratory infections due to
respiratory syncytial virus in young children: a systematic review and meta-
analysis. Lancet, 2010; 375: 1545-1555.
2. Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations
Among Children Less Than 24 Months of Age.Pediatrics, 2013; 132(2): E341-
348.
3. Glezen, W.P. et al. Risk of primary infection and reinfection with
respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
4. Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody
transfer in guinea pigs. Vaccine, 2015; In press.
http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir(at)novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(at)russopartnersllc.com
todd.davenport(at)russopartnersllc.com
212-845-4271
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originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
[HUG#1954971]
Unternehmensinformation / Kurzprofil:
Datum: 29.09.2015 - 12:45 Uhr
Sprache: Deutsch
News-ID 423367
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