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Novavax, Inc. (NVAX) Experimental Influenza Vaccine Meets Main Goal but Delays Further Testing



7/25/2012 6:29:14 AM

ROCKVILLE, Md., July 24, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today reported positive top-line results from the company's Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The study's primary objectives of demonstrating safety and immunogenicity of three ascending dose levels of the quadrivalent influenza vaccine were achieved. The VLP vaccine candidate demonstrated immunogenicity against all four viral strains based on hemagglutination inhibition assay (HAI) responses at day 21, was also well-tolerated with no vaccine-related serious adverse events observed and reactogenicity was considered acceptable. Additional safety and immune response follow-up is continuing through six months post-treatment.

A secondary endpoint of the study was to evaluate the potential of the VLP vaccine to fulfill the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) criteria for accelerated approval. In adult populations under 65 years of age, these criteria are based on demonstration of seroconversion rates (the proportion of subjects with a four-fold rise in HAI titer or attaining a titer of greater than or equal to 1:40 from a negative baseline) and seroprotection rates (the proportion of subjects with HAI titers greater than or equal to 1:40 post-vaccination) that are greater than or equal to 40% and greater than or equal to 70%, respectively, at the lower 95% confidence bound. The VLP vaccine candidate exceeded protocol design expectations by fulfilling the FDA seroprotection criterion at the lower 95% confidence bound for all four viral strains included. The VLP vaccine candidate also demonstrated the potential to fulfill the FDA seroconversion criterion by demonstrating greater than or equal to 40% seroconversion against three of four viral strains. The fourth virus, B/Brisbane/60/08, despite fulfilling the seroprotection criterion, failed to meet the seroconversion criterion. Inclusion of a fourth viral strain in the quadrivalent formulation did not have a significant impact on the immunogenic performance of the other three strains when compared to a trivalent VLP formulation.

An additional secondary endpoint involved evaluation of the immunogenicity of the VLP vaccine at various dose levels in comparison to a licensed trivalent inactivated vaccine (TIV) produced in eggs. The TIV comparator fulfilled the FDA criteria for seroprotection and seroconversion for each of the included three strains. In general, the comparator TIV reached higher levels of HAI than the company's VLP quadrivalent vaccine. Notably, the egg-derived assay reagents used in the classical HAI assay matched the comparator antigens exactly, but may not be perfectly representative of the VLP vaccine antigens. Novavax is currently evaluating the possibility that using virus antigens in the HAI assay that match the VLP vaccine antigen more closely may improve the detection of immune responses to the VLP vaccine.

"The topline data from our seasonal influenza trial released today show that our VLP quadrivalent vaccine candidate was well-tolerated and produced significant HAI responses. Based on our analysis of these data, we believe we have a path forward for our VLP seasonal influenza vaccine," said Stanley C. Erck, President and CEO of Novavax. "While the data from this trial were positive on balance, we are evaluating both process and assay refinements that we believe will further improve the immunogenicity profile of our vaccine, pushing the start of our next Phase II trial into 2013, rather than the fourth quarter of this year," Mr. Erck continued. "We are pleased to have the continued full support from the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) for our development plans."

Novavax expects to present the full findings from this Phase II trial at a future scientific meeting.

About the Phase II Seasonal Influenza Study

The Phase II trial, conducted in Australia, enrolled 500 eligible subjects who were randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants received a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax VLP vaccine or a standard dose of a licensed TIV. Study participants were evaluated at day 21 for HAI response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.

This trial is the first trial evaluating the company's quadrivalent seasonal influenza vaccine candidate produced using its single-use bioprocessing production system. This advanced manufacturing technology will be the basis for its commercial production of seasonal and pandemic influenza vaccines, as well as for the company's RSV and rabies vaccines.

H5N1 Pandemic Influenza Vaccine Program

The company also announced completion of enrollment of its two Phase I clinical trials to evaluate the safety and immunogenicity of its monovalent VLP A/H5N1 pandemic influenza vaccine comparing two different adjuvanted vaccine candidates with an unadjuvanted vaccine candidate. Top line data from these trials are expected in the fourth quarter of this year.

The company is developing both seasonal and pandemic vaccine candidates under a multi-million dollar contract with BARDA, who has been an active partner in planning and evaluating the development of these products. Novavax will use the data from these trials in planning the next stage in the development of these products as they progress toward licensure.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.

Forward-Looking Statements

Statements herein relating to the future of Novavax and its ongoing development of its vaccine 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, 2011, and filed with the Securities and Exchange Commission. 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 www.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: Frederick W. Driscoll

VP, Chief Financial Officer and Treasurer

Novavax, Inc.

240-268-2000


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