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Tuesday, 08/01/2006 7:27:54 AM

Tuesday, August 01, 2006 7:27:54 AM

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Novavax Succeeds in Making Vaccine to Protect Against New Mutation of Avian Influenza

Monday July 31, 9:38 am ET
Novavax to begin pre-clinical testing immediately

MALVERN, Pa., July 31 /PRNewswire-FirstCall/ -- Novavax Inc. (Nasdaq: NVAX - News) -- Novavax Inc. said today its scientists have succeeded in making a vaccine candidate designed to protect against the H5N1 clade 2 influenza virus. Pre-clinical testing of the vaccine has already started.


"We believe this is the first vaccine to be made that targets the H5N1 clade 2 virus isolated from people in Indonesia who have been infected with this mutated version of avian influenza," said Novavax President and Chief Executive Officer Rahul Singhvi. "This is a very significant milestone for Novavax and our proprietary virus-like particle (VLP) vaccine technology. This demonstrates how rapidly we can respond by making a vaccine to protect against emerging pathogens worldwide, compared to older egg-based manufacturing methods."

The H5N1 avian influenza virus is rapidly evolving into antigenically distinct clades, or families. H5N1 clade 1 flu viruses were identified in Vietnam in 2003; by last winter, a second clade was identified in Indonesia. Department of Health and Human Services Secretary Michael O. Leavitt has said that the emergence of clade 2, which is the strain that is spreading throughout Asia and parts of Europe, "dictates that we begin developing a second pre-pandemic vaccine."

Leavitt and other global public health experts maintain that due to H5N1's rapidly mutating nature, multiple vaccines will be needed to protect against the many variations of the virus. The H5N1 vaccines currently in clinical trials by many manufacturers and being stockpiled around the world target only the clade 1 family of the virus.

"It is critical that we have vaccines that can protect against the multiple variations of the virus and, most importantly, against the strains of bird flu that are currently infecting and killing people," said Dr. Rick Bright, Novavax's Vice President of Vaccine Development. "Our vaccine technology allows us to create a vaccine directed at mutated viruses very rapidly so that we can protect people from the newest circulating strains of bird flu. We have also demonstrated in pre-clinical models that we are able to generate protective levels of antibodies against influenza using a single dose of VLP vaccine without the requirement of adding an adjuvant."

Novavax's new vaccine candidate uses the company's VLP technology, which allows scientists to create a particle that is nearly identical to the virus but does not have the virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to attach to cells and trigger a natural immune response -- sometimes from a single dose -- that is capable of protecting against viral infection.

"We are eager to see if this vaccine is as effective in pre-clinical models as we expect it to be," Dr. Bright said. Novavax has already seen successful results from pre-clinical studies of its other pandemic and seasonal influenza vaccines.

Pre-clinical testing of the H5N1 clade 2 vaccine has already been initiated and is likely to take several months. "Once we collect and analyze results of our pre-clinical tests, we will then be in a position to take this timely vaccine into human clinical trials," Dr. Bright said.

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