Bavarian Nordic Successfully Completes End of Phase II Meeting for PROSTVAC(TM)


·       Regulatory agencies endorse the overall Phase III plan for PROSTVAC(TM)
in prostate cancer
·       Bavarian Nordic will now finalise Phase III preparations and an SPA
request for submission to the FDA, while preparing for production and continuing
discussions with potential licensing partners

Kvistgård, Denmark, March 9, 2010 - Bavarian Nordic A/S (OMX: BAVA) announced
today that the company has received Scientific Advice from the European
Medicines Agency and concluded an end of Phase II meeting with the US Food and
Drug Administration (FDA) for the PROSTVAC(TM) programme.  Both agencies
expressed general agreement with the proposed Phase III clinical programme of
PROSTVAC(TM). Based on the consolidated feedback Bavarian Nordic will proceed to
assemble a clinical trial protocol and submit it to the Special Protocol
Assessment (SPA) process with the FDA within a few months. The final clinical
protocol will be based on the outcome of this process.

Based on the consolidated feedback, Bavarian Nordic is planning to achieve
marketing approval for PROSTVAC(TM) via a single global, strongly powered
clinical trial that is expected to enrol about 1,200 patients. The study will be
placebo-controlled and enrol patients with minimally symptomatic,
castration-resistant metastatic prostate cancer, similar to the patient
population studied in the company's placebo-controlled Phase II study.

The previously conducted Phase II study was a prospective randomized,
double-blind, placebo-controlled study of 125 patients with metastatic prostate
cancer. Patients in the PROSTVAC(TM) group had a significantly longer median
overall survival by 8.5 months compared to the control group (p=0.006). The
hazard ratio estimate for overall survival from the study is 0.56 (95% CI
0.37-0.85). The study was published in Journal of Clinical Oncology in January
2010.

Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We are delighted
with the outcome of our dialogue with both FDA and EMEA, as both agencies
expressed general agreement with our clinical strategy to register PROSTVAC(TM).
Although the final protocols still have to be formally agreed with both
agencies, there is now a clear path to registering PROSTVAC(TM) in the US and
Europe."


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


About PROSTVAC(TM)
PROSTVAC(TM) is a therapeutic vaccine moving into late stage clinical
development that has the potential to extend the lives of people with advanced
prostate cancer. Administered subcutaneously, it induces a specific, targeted
immune response that attacks prostate cancer cells. Conventional chemotherapy
currently used to treat prostate cancer has limited survival rates and is often
associated with serious side effects. In contrast, PROSTVAC(TM) has the
potential to extend survival with minimal toxicity. PROSTVAC(TM) is being
developed in collaboration with the National Cancer Institute under a
Cooperative Research and Development Agreement with Bavarian Nordic's U.S.-based
subsidiary, BN ImmunoTherapeutics.

In clinical trials to date PROSTVAC(TM) and related PSA containing poxviral
vaccines have been investigated and in more than 500 patients.


Forward-looking statements
This announcement includes "forward-looking statements" that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.

About Bavarian Nordic
Bavarian Nordic A/S is a leading industrial biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline is focused in
the three areas; cancer, biodefence and infectious diseases, and includes seven
development programmes. Two programmes are under preparation for Phase III:
PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being
developed under a collaboration agreement with the National Cancer Institute and
IMVAMUNE®, a third-generation smallpox vaccine is being developed under a
contract with the US government.

Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.

For more information please visit www.bavarian-nordic.com
<http://www.bavarian-nordic.com/>


[HUG#1392299]


Pièces jointes

2010-16-uk.pdf