Bavarian Nordic Reports Positive Data From First EUA Enabling Study With IMVAMUNE(R)...

Bavarian Nordic Reports Positive Data From First EUA Enabling Study WithIMVAMUNE(R) Smallpox Vaccine CandidateWASHINGTON DC, November 29 /PRNewswire-FirstCall/ -- Bavarian Nordicreports the successful completion of a large, placebo-controlled Phase IItrial in 745 healthy subjects who received either one or two doses ofIMVAMUNE(R) next-generation smallpox vaccine candidate. The results of thisstudy are seen as the pivotal step on the path to moving IMVAMUNE(R) intoPhase III registration trials in order to achieve a BLA for healthy subjects.

This study, together with other Phase II studies with IMVAMUNE(R) inimmune-compromised persons, is also pivotal for obtaining an Emergency UseAuthorization (EUA). Bavarian Nordic expects to receive approval of the EUAapplication in the second-half of 2008.

Traditional smallpox vaccines are associated with a high risk of heartcomplications (e.g. myo-/pericarditis) in approximately 1 in every 150 peoplevaccinated for the first time. Therefore, the purpose of this study, asidefrom assessing general immune response and safety, was to compare cardiacsafety in the different study groups following vaccination with IMVAMUNE(R).The large amount of safety data collected from the 745 people who completedthis study confirmed the promising safety and tolerability profile ofIMVAMUNE(R). Importantly, vaccinations with IMVAMUNE(R) did not result in anyclinically 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 notvaccinated against smallpox. Similarly, a single vaccination with IMVAMUNE(R)boosted the immune response in the majority of people who had historicallybeen vaccinated against smallpox.

This study completes the Phase II development of IMVAMUNE(R) in healthysubjects and now leads to planning with the FDA on the design of the PhaseIII studies expected to begin in 2008.

Anders Hedegaard, President & CEO, said: "We are very satisfied withthese results which bring us closer to our EUA application which representsan important milestone in the development of IMVAMUNE(R) as the modernsmallpox vaccine."

About Bavarian Nordic

Bavarian Nordic, headquartered in Denmark, is a leading internationalbiopharmaceutical company developing and producing innovative vaccines toprevent and treat infectious diseases and cancer.

In the U.S., Bavarian Nordic operates subsidiary companies, BNImmunoTherapeutics, in Mountain View, California developing vaccines againstcancers, and Bavarian Nordic Inc. in Washington, D.C. focused on businessdevelopment, marketing, and government relations for the Bavarian NordicGroup. For more information on Bavarian Nordic visit:http://www.bavarian-nordic.com

"Safe Harbour" Statement under the Private Securities Litigation ReformAct of 1995": Except for the historical information contained herein, thisrelease contains "forward-looking statements" within the meaning of thePrivate Securities Reform Act of 1995. No "forward-looking statement" can beguaranteed, 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, futureevents, or otherwise. Additional information regarding risks anduncertainties is set forth in the current Annual Report and in BavarianNordic's periodic reports, if any, which we incorporate by reference.SOURCE Bavarian Nordic A/SElizabeth Dempsey Becker, Bavarian Nordic, Inc., +1-202-536-1576