Bavarian Nordic A/S reports positive data from first EUA enabling study with IMVAMUNE® smallpox vaccine

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® third-generation
smallpox vaccine. The results of this study are seen as the pivotal
step on the path to moving into Phase III registration trials in
order to achieve a BLA for healthy subjects.

The study, together with other Phase II studies with IMVAMUNE® in
immune-compromised persons, is pivotal for obtaining an Emergency Use
Authorization (EUA). The company still expects to receive approval of
the EUA application in 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, aside from
assessing general immune response and safety, the primary focus of
this study was to compare cardiac safety in the different study
groups following vaccination with IMVAMUNE®. The large amount of
safety data collected from the 745 people who completed this study
confirmed the excellent safety and tolerability profile of IMVAMUNE®.
Importantly, vaccinations with IMVAMUNE® did not result in any
clinically significant abnormal cardiac findings and no cardiac
events (e.g. cases of myo-/pericarditis) that have been reported for
traditional smallpox vaccines.

Moreover, vaccinations with IMVAMUNE® resulted in seroconversion
(detectable immune responses) in almost all subjects (98.9%)
previously not vaccinated against smallpox. Similarly, a single
vaccination with IMVAMUNE® boosted the immune responses in the
majority of people whom had historically already been vaccinated
against smallpox.

This study completes the Phase II development of IMVAMUNE® in healthy
subjects and this now leads to planning with the FDA on the design of
the Phase III study that is planned to commence in 2008.

Anders Hedegaard, President & CEO, said: "We are very satisfied with
these results which brings us closer to our EUA application which
represents an important milestone in the development of IMVAMUNE® as
the modern smallpox vaccine the world has been waiting for."




Asger Aamund
Chairman



Contacts:

Anders Hedegaard, President & CEO
Telephone: +45 33 26 83 83

Media: United States of America
Elizabeth Dempsey Becker, Bavarian Nordic Inc.
Telephone: +1 202 536-1576