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NOVAVAX Completes First Stage of Enrollment in Pivotal H1N1 Influenza Vaccine Study in the Country of Mexico
Date:11/16/2009

ROCKVILLE, Md., Nov. 16 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned. The study is being conducted in Mexico City in collaboration with Avimex Laboratories. The first stage of the study is evaluating the vaccine's safety, immunogenicity and exploratory efficacy among 1,000 healthy adults, including 750 VLP vaccine recipients and 250 placebo recipients. The results of this phase of the blinded, dose-ranging placebo-controlled study will be used to select a dose for evaluation in the second stage of the clinical study in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The results of this study will be used to support registration of Novavax's 2009 H1N1 VLP pandemic influenza vaccine in Mexico as well as in the future development of Novavax's pandemic and seasonal influenza vaccines in other countries.

"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine.
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SOURCE Novavax, Inc.
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