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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 persons diagnosed with atopic dermatitis.

Atopic Dermatitis Prevalence and Smallpox Vaccination

A review by medical specialists investigating the risk to persons with atopic dermatitis for developing serious side effects from traditional smallpox vaccines, suggests that up to half of the U.S. population could be at risk to the vaccine. The authors note that the lifetime prevalence of atopic dermatitis is approximately 10%-15% of the population and estimate that the same amount of people has a history of the condition(s). They further project that it is probable that twice this amount of people have contact with others who have an active case or history of atopic dermatitis, suggesting the possibility that up to half of the population could be at risk to developing complications from vaccination with or exposure to traditional smallpox vaccines.(1)

The most recent report of accidental exposure to the smallpox vaccine was the highly-publicized case of a two-year-old boy with a history of eczema that developed a serious reaction after coming in contact with the vaccinia virus from his father's smallpox vaccination.(2)

Government Guidance - Atopic Dermatitis and Smallpox Vaccination

According to the Centers for Disease Control and Prevention (CDC) persons with atopic dermatitis as well as those who have had it in the past should not receive the current smallpox vaccine because of the risk of developing severe adverse reactions to the replicating virus found in the vaccine. Additionally, due to the risk of accidental exposure to the vaccine, persons with individuals in their households with atopic dermatitis are also advised not to be given the smallpox vaccine.(3)

Bavarian Nordic's new, patented developmental smallpox vaccine, IMVAMUNE(R), is based on the Modified Vaccinia Ankara (MVA) virus. In contrast to traditional smallpox vaccines, MVA is a live virus that does not replicate in human cells which means that the potential for adverse side effects are diminished and as a result does not pose a risk to others.

References:

(1) Engler RJM, Kenner J, Leung DYM. Smallpox vaccination: risk considerations for patients with atopic dermatitis. J Allerg Clin Immunol 2002;110(3):357-65

(2) http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5619a4.htm

(3) http://emergency.cdc.gov/agent/smallpox/vaccination/live-virus.asp

About Bavarian Nordic

Bavarian Nordic, headquartered in Denmark, is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer.

In the U.S., Bavarian Nordic operates subsidiary companies, BN ImmunoTherapeutics, in Mountain View, California developing vaccines against cancers, and Bavarian Nordic Inc. in Washington, D.C. focused on business development, marketing, and government relations for the Bavarian Nordic Group. For more information on Bavarian Nordic visit: http://www.bavarian-nordic.com

"Safe Harbour" Statement under the Private Securities Litigation Reform Act of 1995": Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. No "forward-looking statement" can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any "forward-looking statement", whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.


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SOURCE Bavarian Nordic A/S
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