GAITHERSBURG, Md., May 25, 2016
(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 that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation to Novavax'
RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) for
the protection of older adults (60 years of age and older).
"The FDA's granting of Fast Track
designation for our RSV F Vaccine in older adults underscores its
recognition of RSV as a significant unmet medical need in this
large population segment," said Stanley C. Erck, President and
CEO. "This joins our prior Fast Track designation for the RSV F
Vaccine for the protection of infants via maternal immunization.
Fast Track designation could allow for an expedited timeline to
licensure, accelerating the access to this vaccine for the most
vulnerable populations."
It is estimated that 16,000 older
adults die of RSV infection or its complications annually in the
U.S., with approximately 900,000 medical interventions for a total
economic burden of disease of approximately $28 billion. We fully
enrolled the Resolve(TM) Phase 3 clinical trial of our RSV F
Vaccine in 11,850 older adults in December 2015. The primary
efficacy objective of the Resolve trial is the prevention of
moderate-severe RSV-associated lower respiratory tract disease, as
defined by the presence of multiple lower respiratory tract
symptoms.
Gregory M. Glenn, M.D., President,
Research and Development, said, "RSV is a widespread disease that
causes infections of the lower respiratory tract. While RSV affects
individuals of all ages, it acutely impacts older adults and
infants. Our Phase 3 Resolve trial will examine the efficacy of our
RSV F Vaccine and further define the burden of disease in older
adults. We look forward to announcing data from the trial in the
third quarter of this year."
The Fast Track Drug Development
Program was established under the FDA Modernization Act of 1997 and
is intended to facilitate development and expedite review of drugs
to treat serious and life-threatening conditions so that an
approved product can reach the market expeditiously. Specifically,
Fast Track designation facilitates meetings to discuss all aspects
of development to support licensure and provides the opportunity to
submit sections of a Biologics License Application (BLA) on a
rolling basis as data become available, which permits
the FDA to review modules of the BLA as they are received
instead of waiting for the entire BLA submission. Finally, priority
review (6 month review versus standard 10 month review) is a
potential benefit that may be available to Novavax' RSV F
Vaccine in the future.
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. A.R. Falsey et al.
Respiratory syncytial virus infection in elderly and high-risk
adults. N Engl J Med. 2005; 352:1749-59.
2. A.R. Falsey et al.
Respiratory syncytial virus and influenza A infections in the
hospitalized elderly. J. Infect Dis.
1995; 172:389-94.
3. K. Widmer et al. Rates of
hospitalizations for respiratory syncytial virus, human
metapneumovirus, and influenza virus in older adults. J Infect Dis. 2012; 206: 56-62.
4. K. Widmer et al. Respiratory
syncytial virus & human metapneumovirus-associated emergency
department and hospital burden in adults. Influenza and Other Respiratory Viruses. 2014; 8(3):
347-352.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Associate Director, 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