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Novavax Management Discusses Q2 2012 Results - Earnings Call Transcript

Let's start with our seasonal flu vaccine program. The positive top-line results we announced last week from the Phase II dose-ranging clinical trial of our quadrivalent vaccine. As you saw on our recent press release, the study was designed to evaluate both immunogenicity and safety of 3 dose levels of our quadrivalent vaccine in healthy adults between the ages of 18 and 64 years old. As we reported, the trial reached its primary endpoints of demonstrating safety and immunogenicity in all 3 dose levels. As always, we first look at safety. The safety results are key, not only to this product, but to our entire product platform. And I'm happy to report that we again saw in this trial a clean safety profile and didn't see anything that causes us concern going forward.

I should note that with this last trial, we have now tested our influenza VLP vaccines in over 5,000 subjects. Demonstrating immunogenicity, we measured hemoglobin inhibition or HAI responses at day 21. The 2 primary measurements of immunogenicity that are commonly used for an influenza vaccine are the level of 0 protection, which is the percent of vaccine, vaccine means and achieves a certain level of AHI titers in 0 conversion, which is the percent of vaccines and vaccinees that achieved a fourfold increase in the level of HAI titer. Quadrivalent vaccine that the FDA 0 protection requirements were all 4 viral stains with 0 conversion levels from 3 out of the 4 strains. The 0 conversion for the remaining strain, the B "Brisbane" strain, fell below the FDA guideline. There are a few potential reasons for this and we have already initiated a number of actions to address this issue before we launch our next Phase II study in 2013.

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