Novavax Initiates Phase 2 Clinical Trial of Quadrivalent Seasonal Influenza VLP

GAITHERSBURG, Md., 2014-11-17 22:05 CET (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). This trial is being conducted under the company's contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO 100201100012C) for the development of Novavax' recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential.

Novavax' technology platform enables the creation of recombinant, strain-specific VLPs. Novavax' Seasonal Influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens. Antibodies to both hemagglutinin and neuraminidase have been shown to contribute to resistance to influenza illness. Because these VLP constructs elicit immune responses to both hemagglutinin and neuraminidase molecules in the four strains of seasonal influenza, it is expected that immunized subjects will be protected from influenza infection and disease-related symptoms.

The trial is a randomized, observer-blinded, dose-ranging trial designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adult subjects. The primary outcomes of the trial will assess safety and tolerability of the Seasonal Influenza VLP and quantify immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers. In addition, secondary outcomes will evaluate neuraminidase-inhibition antibody titers for all four influenza strains.

"We are delighted to announce the initiation of this Phase 2 clinical trial of our Seasonal Influenza VLP. We believe this vaccine has the potential to provide a differentiated immune response through the presentation of both hemagglutinin and the intact neuraminidase antigen," said Stanley C. Erck, President and CEO of Novavax. "That differentiated immune response has the potential to deliver more robust protection against infection. We are committed to moving this product from this current trial into clinical efficacy trials."

About Influenza

Influenza virus is an airborne, respiratory pathogen that is generally transmitted by inhalation of infectious droplets of respiratory secretions, although transmission through contaminated objects in the environment can also occur. The virus infects the upper respiratory lining of the nose, throat, bronchi, and occasionally the lungs. Although the majority of people recover within one to two weeks without medical treatment, influenza can be associated with pneumonia and even death, especially in the very young, the elderly, and persons with underlying medical conditions. Influenza is a seasonal disease, occurring in yearly winter epidemics of varying and unpredictable severity. Recent estimates in the U.S. show that nearly 250,000 influenza-associated hospitalizations occur annually as a result of each seasonal epidemic with estimated influenza associated deaths ranging from 3,000 to nearly 50,000 per year. Annual influenza immunization is recommended for everyone by the U.S. Center for Disease Control.

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.

About the Novavax HHS-BARDA Contract

The contract was originally awarded in February 2011, with funding of up to $97 million over an initial base period ending in February 2014, and subsequently extended to September 2014. Through the second quarter of 2014, Novavax recognized approximately $65 million in revenue since the inception of the contract. During the contract's 43-month base period, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. In September 2014, BARDA exercised the option period of the contract and extended the period of performance through September 2016. The milestones under the option period are focused on activities leading up to initiation of Phase 3 clinical trials.

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, filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our 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 we undertake no obligation to update or revise any of the statements. Our 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
         
         David Schull or Andrea Flynn, Ph.D.
         Russo Partners, LLC
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         David.schull@russopartnersllc.com
         Andrea.flynn@russopartnersllc.com