Bavarian Nordic Reports Positive Data from First EUA Enabling Study with IMVAMUNE(R) Smallpox Vaccine Candidate

    WASHINGTON, DC, November 29 /PRNewswire-FirstCall/ -- Bavarian Nordic
 reports the successful completion of a large, placebo-controlled Phase II
 trial in 745 healthy subjects who received either one or two doses of
 IMVAMUNE(R) next-generation smallpox vaccine candidate. The results of this
 study are seen as the pivotal step on the path to moving IMVAMUNE(R) into
 Phase III registration trials in order to achieve a BLA for healthy
 subjects.
 
     This study, together with other Phase II studies with IMVAMUNE(R) in
 immune-compromised persons, is also pivotal for obtaining an Emergency Use
 Authorization (EUA). Bavarian Nordic expects to receive approval of the EUA
 application in the second-half of 2008.
 
     Traditional smallpox vaccines are associated with a high risk of heart
 complications (e.g. myo-/pericarditis) in approximately 1 in every 150
 people vaccinated for the first time. Therefore, the purpose of this study,
 aside from assessing general immune response and safety, was to compare
 cardiac safety in the different study groups following vaccination with
 IMVAMUNE(R). The large amount of safety data collected from the 745 people
 who completed this study confirmed the promising safety and tolerability
 profile of IMVAMUNE(R). Importantly, vaccinations with IMVAMUNE(R) did not
 result in any clinically significant abnormal cardiac findings and no
 cardiac events (e.g. cases of myo-/pericarditis).
 
     Moreover, vaccinations with IMVAMUNE(R) resulted in seroconversion
 (detectable immune responses) in almost all subjects (98.9%) previously not
 vaccinated against smallpox. Similarly, a single vaccination with
 IMVAMUNE(R) boosted the immune response in the majority of people who had
 historically been vaccinated against smallpox.
 
     This study completes the Phase II development of IMVAMUNE(R) in healthy
 subjects and now leads to planning with the FDA on the design of the Phase
 III studies expected to begin in 2008.
 
     Anders Hedegaard, President & CEO, said: "We are very satisfied with
 these results which bring us closer to our EUA application which represents
 an important milestone in the development of IMVAMUNE(R) as the modern
 smallpox vaccine."
 
     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.
 
 
 

SOURCE Bavarian Nordic A/S