Novavax Announces Grant of Up to $89 Million to Support Development of RSV F Vaccine to Protect Infants Via Maternal Immuniza...
September 29 2015 - 6:45AM
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_9x10.pdf
About RSVRespiratory 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, respectively1. In the US, RSV is the leading cause of
hospitalization of infants2. Despite the induction of
post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common3,4. 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 NovavaxNovavax, 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™ 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:
- 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.
- Hall, C.B. et al. Respiratory Syncytial Virus-Associated
hospitalizations Among Children Less Than 24 Months of Age.
Pediatrics, 2013; 132(2): E341-348.
- Glezen, W.P. et al. Risk of primary infection and reinfection
with respiratory syncytial virus. Am J Dis Child, 1986;
140:543-546.
- 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@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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