Bavarian Nordic reports successful safety data from Phase II study with IMVAMUNE®

Bavarian Nordic has completed a clinical safety report from a large
Phase II study with IMVAMUNE® in HIV infected subjects that confirms
the excellent safety profile of IMVAMUNE®. Within the next few days
the safety report of this study will be submitted to the FDA and this
will trigger a USD 25 million milestone payment under the RFP-3
contract. The clinical safety report constitutes a major part of the
data package that will be used to potentially support the use of
IMVAMUNE® in a declared emergency.

In support of using IMVAMUNE® as a smallpox vaccine in individuals
otherwise contraindicated to receive conventional vaccinia vaccines,
Bavarian Nordic has performed a large Phase II study in HIV infected
subjects with CD4 counts between 200 and 750 cells/µl to compare the
safety to healthy subjects.

The safety report from this study, which represents an essential part
of the EUA data package, includes safety data from over 300 HIV
infected and 86 healthy subjects, all of whom had no history of prior
smallpox vaccination. The low number of adverse events confirmed the
favourable safety profile of IMVAMUNE® in vaccinia-naïve HIV infected
subjects with varying degrees of immune suppression. Indeed, there
was no difference in adverse events between the healthy and HIV
infected subjects, even in the most immune compromised patients (CD4
counts >= 200-350 cells/µl). IMVAMUNE® has now been tested in more
than 2,200 people in 11 completed or on-going clinical studies, which
includes a large proportion (more than 750) of immune-compromised
people i.e. HIV infected or diagnosed with Atopic Dermatitis (AD) who
are excluded from vaccination with traditional smallpox vaccines.

The complete data set from this trial is expected to be reported in
the second half of 2009. The final report will include data on
immunogenicity as well as long-term (6-month) safety information and
will contain data from subjects enrolled in an additional study arm
funded by the NIH under RFP-2 (HIV infected subjects with a history
of previous exposure to a conventional smallpox vaccine).

This announcement does not change Bavarian Nordic's previously
announced financial guidance for 2008.


Kvistgård, 5 November 2008

Asger Aamund
Chairman


Contact: Anders Hedegaard, President & CEO | +45 23 20 30 64