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2014-05-12

Novavax, Inc.: One Year Follow-Up From RSV F-Protein Vaccine Candidate Phase 1 Elderly Trial Demonstrates Sustained Levels of Immune Response

* Sustained levels of RSV F antibody and palivizumab-competing antibody
responses demonstrated over a 4 to 6 month period
* Results support accelerating development plans for "seasonal" elderly RSV
vaccine
* Phase 2 clinical trial in elderly anticipated to start in
late-2014/early-2015

GAITHERSBURG, Md., May 12, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX) today announced follow-up data from its dose-ranging Phase 1
clinical trial of its respiratory syncytial virus (RSV) F-protein vaccine in
220 elderly adults (60 years of age and older, with a mean age of 68) that
was initiated in October 2012. In the placebo-controlled trial, subjects
received a single injection of either 60µg or 90µg of the RSV F-protein
vaccine candidate, with or without aluminum phosphate as an adjuvant.

Positive top-line interim safety and immunogenicity data released by Novavax
in July 2013 described antibody responses 28 and 56 days post-immunization.
Overall immune responses were greater in groups receiving the 90ug dose
compared to the groups dosed with 60µg. Also, robust anti-F IgG responses and
palivizumab competing antibody (PCA) responses were observed in all vaccine
recipients. Notably, by day 56, subjects receiving the 90ug dose without
adjuvant achieved PCA responses at a geometric mean of 142ug/ml, which
approximate the peak levels seen in pharmacokinetics trials of palivizumab in
infants receiving repeat palivizumab injections (~150µg/ml) and exceeded
trough levels seen (~70µg/ml) in those same studies, indicating that the
vaccine induced antibody levels that are likely to be protective.

In the one-year follow up data released by Novavax today, the company reported
that the group receiving the 90ug dose without adjuvant, anti-F levels and
PCA were significantly elevated over baseline at day 118, with a geometric
mean of 130ug/ml, and at day 180, with a geometric mean of 114ug/ml. For the
same group, at day 180, anti RSV A neutralizing antibodies were log28.8 and
RSV B neutralizing antibodies were log29.0, both considered protective levels
in seroepidemiology studies.

"Typically, RSV season lasts four to five months, so it was important to see
follow-up data which support that our vaccine could be protective across a
full RSV season, similar to seasonal influenza vaccination. Our data suggest
that, since protective levels are diminished at day 365, annual boosts of our
vaccine may be warranted," said Dr. Gregory Glenn, Senior Vice President of
Research and Development at Novavax. "The monoclonal antibody palivizumab has
been shown to protect infants against severe RSV disease but has only a
21-day half-life and is therefore given in multiple injections to sustain
protective levels. A single dose of our RSV F vaccine candidate appears to
sustain immunity in the elderly at levels that exceed what was protective in
infants, and does so over a long-enough period of time to cover an entire RSV
season."

Stan Erck, President and CEO of Novavax, stated, "We were pleased to see that
a 90ug dose of our RSV F vaccine candidate was immunogenic and sustained
levels that appear to be protective over an entire RSV season. These results
encourage us to accelerate our development plans to include an annual
seasonal RSV vaccine for the elderly where there is a burden of disease and
incidence rate similar to that of an influenza virus, and clearly support
initiation of a Phase 2 clinical trial as early as later this year or
early-2015.

About RSV

RSV is a major respiratory pathogen in infants, children, and adults. RSV
infections in adults represent re-infections and are generally mild to
moderate in severity, except in persons with high-risk conditions including
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 and up to 180,000 admitted to hospital with respiratory
symptoms. Currently, there is no approved RSV prophylactic 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 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.

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, 2013, and filed with the Securities and Exchange Commission
(SEC). Investors are cautioned not to place considerable reliance on the
forward-looking statements contained in this press release. You are
encouraged to read company 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 the company undertakes no obligation to update or revise any of the
statements. The company's 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

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

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