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Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age - Seite 2

-- Clear increases in RSV neutralizing antibodies were also shown across all
doses and formulations, and were strongest in women entering the study with
the lowest baseline levels, in confirmation of prior studies.
-- Vaccine-induced palivizumab-like antibody levels demonstrated strong
concordance with anti-RSV-F antibody responses. A single 120 ug antigen
dose generated peak palivizumab-like antibody levels of approximately 400
ug/mL, the highest levels seen in any study.
-- Kinetic analysis of the antibody responses showed rapid increases in
antibody levels in all vaccine formulations and dosing regimens. A single
120 ug antigen dose generated peak RSV-F and palivizumab-like antibody
levels within 14 days of immunization, and high levels of both were
sustained through the 91-day observation period.

'Our vaccine has again performed in a highly consistent manner from a safety
and immunogenicity perspective. In testing for an optimal formulation, we have
delivered improved immunogenicity in a one-dose regimen. We believe such a
regimen will improve patient convenience, vaccine uptake and compliance, thus
decreasing the burden of RSV disease. In addition, we believe that the rapid
and sustained antibody response displayed by a single-dose formulation of our
vaccine provides significant flexibility for administration during pregnancy,'
said Gregory Glenn M.D., Senior Vice President Research and Development at
Novavax. 'Together with our previous clinical trial in women of childbearing
age, these data support our first maternal immunization trial, currently
projected for the 4th quarter of 2014. We have requested a Type C meeting with
the FDA this summer, at which time we will discuss our suite of pre-clinical
and clinical data in support of our application to proceed to studies in
pregnant women.'

This clinical trial is being conducted in collaboration with PATH, an
international nonprofit organization that drives transformative innovation to
save lives and improve health. PATH committed funding of approximately $3.5
million to support this trial with the aim of advancing the development of an
RSV vaccine to protect infants through maternal immunization in low-resource
countries. Novavax expects to present the entire date-set at an appropriate
scientific forum in the future.

About RSV

RSV is a respiratory pathogen that afflicts all humans regardless of age. In
healthy adults, RSV infections are generally mild to moderate in severity, but
may be more severe in infants and young children as well as the elderly and
adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a