Novavax, Inc and the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) have signed an agreement to cooperate in the evaluation of a virus-like particle (VLP) vaccine candidate against the novel influenza A (H1N1) virus. Novavax has produced influenza A (H1N1) VLP vaccine against the strain recommended by the Centers for Disease Control and Prevention (CDC).

Novavax scientists produced the first batch of H1N1 VLPs within the company's laboratories in May, just three weeks after the CDC announced the genetic sequence of a novel influenza A (H1N1) virus. This strain of influenza was isolated from an infected person located in California. These VLPs contain the hemagglutinin (HA), neuraminidase (NA) and matrix 1 (M1) proteins found in the newly emerged H1N1 influenza strain. The size and structure of the VLPs are nearly identical to those of the novel H1N1 virus but the VLPs are not infectious as they lack the genes necessary for replication. Novavax has made purified influenza A (H1N1) VLPs, which are being sent to scientists at the CDC and DMID for studies in animal models.

"The company has committed necessary resources to respond as rapidly as possible to construct and manufacture VLP vaccine against this new H1N1 influenza virus," said Rahul Singhvi, president and CEO of Novavax. "Our proprietary recombinant cell culture technology has enabled production of custom VLPs against this strain of influenza within weeks. This ability to respond rapidly is an important factor in the evaluation of alternative investigational vaccines against this emerging threat to public health."

The influenza A (H1N1) virus was first detected in April 2009, in Mexico, the United States and Canada and has subsequently spread rapidly to over sixty countries worldwide. Although illnesses to date have been of a similar severity as that of typical seasonal influenza, it is unclear if the strain will evolve to become more deadly over the course of the next several months. Therefore, technology that can lead to rapid production of vaccines is important to reduce the spread of the virus and to potentially prevent a pandemic from occurring. Novavax believes that its influenza VLP vaccine technology could be part of the solution for influenza pandemics as will be demonstrated in this instance by release of a vaccine lot produced under cGMP against the novel influenza A H1N1 strain within approximately 12 weeks or less of the CDC announcement of the new
strain.

Novavax has completed genetic engineering and manufacture of the master seed stock necessary to produce larger quantities of the investigational influenza A (H1N1) VLP vaccine under cGMP conditions in its manufacturing facility in Rockville, Maryland.

Novavax is a clinical stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary virus like particle (VLP) technology.