Bavarian Nordic has essentially agreed a pathway for the licensure of IMVAMUNE® with the FDA after successful end of Phase II meeting

Following the completion of the Phase II clinical development of
IMVAMUNE®, a third-generation smallpox vaccine, Bavarian Nordic has
held an end of Phase II meeting with the FDA to discuss the Phase III
development. The meeting was a success and there was an open and
highly constructive discussion with the FDA.

This meeting represented the first ever formal discussions with the
agency to license a vaccine under the new legislation of the animal
rule - a new regulatory path which allows the efficacy of products
for indications like smallpox to be established in suitable animal
efficacy models. This marks a major regulatory milestone in the
successful development of IMVAMUNE®.

The animal efficacy models and phase III protocol have essentially
been agreed with the agency - outlining a clear path for licensure of
IMVAMUNE®. Once all protocols have been agreed with the FDA a
Vaccines Related Biological Product Advisory Committee (VRBPAC) will
be scheduled to ratify the license strategy. This exceptional review
path will likely push the initiation of the Phase III studies into
late 2010, leading to the submission of a BLA in 2013.

The outcome of the meeting has no impact on the delivery of vaccines
to the Strategic National Stockpile (SNS) under the RFP-3 contract
with the US government, which is still expected to be initiated in
2009.

In clinical trials to-date, IMVAMUNE® has shown to be safe and well
tolerated in more than 2,400 people including more than 900 immune
compromised people, either infected with HIV or diagnosed with atopic
dermatitis. These clinical studies have demonstrated that IMVAMUNE®
induces a fast and strong immune response, which is comparable to
that induced by traditional smallpox vaccines. However, the efficacy
of IMVAMUNE® cannot be established in the clinic, because smallpox no
longer exist in the general population and will have to rely on the
animal rule. To this end Bavarian Nordic has developed a number of
efficacy models and has demonstrated IMVAMUNE® induces a comparable,
if not superior, efficacy to that of traditional smallpox vaccines.

Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We are
delighted with the outcome of the meeting with the FDA, as our plans
to license IMVAMUNE® were essentially agreed with the FDA. Although
the final protocols still have to be formally agreed with the agency
there is now a clear path to registering IMVAMUNE®."

Asger Aamund
Chairman

Contact
Anders Hedegaard, President & CEO.
Phone +45 23 20 30 64