Bavarian Nordic Announces Positive Mature Phase II Results From Newly Acquired Prostate Cancer Vaccine

KVISTGÅRD, Denmark, October 7 (ots/PRNewswire) -

- 125 Patient, Prospective Randomized Placebo-Controlled Phase II
Study Shows Statistically Significant Improved Overall Survival

KVISTGÅRD, Denmark, October 7 /PRNewswire/ --

Bavarian Nordic has now evaluated the mature phase II data from
the therapeutic prostate cancer vaccine candidate PROSTVAC(TM) that
had been obtained as part of the recently entered partnership with
the National Cancer Institute (NCI) in the US.

The results from the Phase II prospective randomized
placebo-controlled study of 125 patients with advanced prostate
cancer after 4 years of follow-up show that patients receiving
PROSTVAC(TM) had a statistically significantly longer median overall
survival by 8.5 months (p=0.015) compared to the control group.
Currently the only approved treatment for advanced prostate cancer
extends median overall survival by an average of approximately 2
months. In addition, PROSTVAC(TM) also had a favourable safety and
tolerability profile.

Based on these promising results, Bavarian Nordic expects to
initiate confirmatory Phase III studies for PROSTVAC(TM) together
with NCI in the first half of 2010 that will form the basis of
approval for this therapy.

Prostate cancer is the most common form of cancer with more than
500,000 new diagnosed patients globally per year and only limited
treatment options. With estimated more than 140,000 related deaths
annually, prostate cancer is the third leading cause of cancer
related deaths in men.

Philip Kantoff MD, Professor of Medicine, Harvard Medical School,
the principal investigator of the study, said "There are few
available treatments for advanced prostate cancer. To see this extent
of improvement in overall survival is very encouraging. These phase
II data with PROSTVAC(TM) warrant confirmation with a phase III study
and when confirmed this product has the potential to fulfil an unmet
medical need for these patients."

Anders Hedegaard, President and Chief Executive Officer, Bavarian
Nordic A/S, said "We are delighted with these promising results from
this Phase II study, which will be published in full over the coming
months. Based on these data we believe that PROSTVAC(TM) offers a
potential breakthrough and real hope for patients suffering from
advanced prostate cancer. Furthermore, unlike other current prostate
cancer vaccines in development, PROSTVAC(TM) is an off-the shelf
product that does not require complex individualised therapy. These
results provide a full endorsement for our decision to strengthen our
presence in cancer vaccine research, as announced earlier this year
in connection with our newly launched strategy."

This announcement does not change Bavarian Nordic's previously
announced financial guidance for 2008. The decision to take
PROSTVAC(TM) into phase III trials will have a limited financial
impact on year 2009, which will be covered by the company's net free
liquidity.

Asger Aamund

Chairman

Conference call

A conference call will be held today, 7 October 2008 at 10:30 am
(CEST). Anders Hedegaard, President & CEO and Reiner Laus MD and CEO
of BN ImmunoTherapeutics Inc. will present. The accompanying
presentation will be available on the company's website:
http://www.bavarian-nordic.com in advance.

Dial-in numbers for the conference call are:
UK: +44(0)20-7162-0025,
US: +1-334-323-6201.

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 business strategy is focused in three areas:
biodefence, cancer and infectious diseases. Bavarian Nordic's
proprietary and patented technology MVA-BN(R) is one of the world's
safest, multivalent vaccine vectors. Bavarian Nordic has ongoing
contracts with the US government for the late-stage development and
procurement of the company's third-generation smallpox vaccine,
IMVAMUNE(R).

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

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

About the NCI

The National Cancer Institute (NCI) is part of the National
Institutes of Health (NIH) and is the United States federal
government's leading cancer research organization. NCI has played an
active role in the development of drugs for cancer treatment for over
50 years. This is reflected in the fact that approximately one half
of the chemotherapeutic drugs currently used by oncologists for
cancer treatment were discovered and/or developed at NCI. The
organisation has supported the research efforts of at least 20 Nobel
Prize winners. For approximately half of these Nobel laureates, NCI
supported the awarded research. According to a 1996 NCI analysis of
drugs approved by the FDA, two-thirds of the anti-cancer drugs
approved as of the end of 1995 were NCI-sponsored Investigational New
Drugs.

About PROSTVAC(TM)

PROSTVAC(TM) (Vaccinia-PSA-TRICOM and Fowlpox-PSA-TRICOM) 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 metastatic cells in the
prostate. Conventional chemotherapy currently used to treat prostate
cancer has limited survival rates and is often associated with
numerous side effects. In contrast, PROSTVAC(TM) has the potential to
extend survival with improved quality of life.

In clinical trials to date PROSTVAC(TM) has been investigated in
464 patients over 10 years. The Phase III programme is currently
being planned.

About prostate cancer

Prostate cancer had an incidence of more than 500,000 cases
worldwide in 2007. It has thus become the most frequent cancer in men
and has become more frequent than lung cancer and colon cancer. With
estimated more than 140,000 related deaths annually, prostate cancer
is the third leading cause of cancer related deaths in men. The age
adjusted cancer death rates for prostate cancer have doubled since
1930; among other leading malignant diseases only lung cancer has
shown a worse development in this century. These tendencies developed
even though the five year survival rates for localized prostate
cancer have been continuously improved. However, the treatment for
metastatic prostate cancer has not been improved in recent years.
Prostate cancer is resistant to conventional chemotherapy. The only
mechanism that has been used so far in disseminated disease with some
effect is hormone treatment. Hormone therapy slows the tumor growth
by stopping or blocking testosterone from entering the cancer cells.
Prostate cancer cells are typically dependent on testosterone or
other androgens as growth factors. Thus, although initially
effective, hormone therapy becomes ineffective after a period of
time. Chemotherapy for disseminated disease at this stage is very
limited with only one chemotherapeutic agent approved for the
treatment of metastatic prostate cancer that extends survival by - 2
months, with toxic side effects. All other therapies for this stage
of disseminated prostate cancer are palliative and do not prolong
survival. Thus, improved therapies for prostate cancer are urgently
needed.

Contact:
Anders Hedegaard, President & CEO -
+45-23-20-30-64;
Vicki Martin, Axon Communications -
+44-208-439-9407 / vmartin@axon-com.com .

ots Originaltext: Bavarian Nordic A/S
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Anders Hedegaard, President & CEO - +45-23-20-30-64; Vicki
Martin, Axon Communications - +44-208-439-9407 / vmartin@axon-com.com
.