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Government Expands Trial With IMVAMUNE(R) Smallpox Vaccine in Persons With Atopic Dermatitis/Eczema
Date:10/10/2007

WASHINGTON, October 10 /PRNewswire-FirstCall/ -- The National Institutes of Allergy and Infectious Diseases (NIAID) has extended an existing contract (RFP-2) with Bavarian Nordic to include the initiation of a larger Phase II study with IMVAMUNE(R), the company's investigational smallpox vaccine, in persons diagnosed with atopic dermatitis. The contract extension will prolong the original contract to 2010 and has a value of US$15 million, with the majority of revenue expected at the end of 2008 and beginning of 2009.

Anders Hedegaard, President & CEO of Bavarian Nordic, said, "We are very pleased that the U.S. Government has decided to extend the ongoing RFP-2 contract to include clinical studies in people with atopic dermatitis, one of the largest risk groups for experiencing adverse reactions associated with traditional smallpox vaccines. This is an important step in our efforts to develop a safe next-generation smallpox vaccine for the entire population, and it builds further on our long-term partnership with the U.S. Government."

The original RFP-2 contract, awarded in 2004 by NIAID, included a Phase II study with IMVAMUNE in persons diagnosed with atopic dermatitis. However the need for more clinical safety data in this population has increased due to requirements from the Food and Drug Administration (FDA) to generate data to support an Emergency Use Authorization (EUA) for IMVAMUNE.

Bavarian Nordic is the only company developing a new next-generation smallpox vaccine designed to be safe and effective for all persons, regardless of their health condition. In 2004, the company expanded its IMVAMUNE smallpox vaccine program to include persons diagnosed with atopic dermatitis. Results of Phase I studies have shown IMVAMUNE to be safe and well-tolerated in this population. The clinical development program has since progressed to a multi-center Phase II study in the USA and Mexico to investigate the safety and immunogenicity of IMVAMUNE in
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SOURCE Bavarian Nordic A/S
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