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2014-04-28

Bavarian Nordic A/S: Bavarian Nordic Announces First Patient Treated in a Phase 2 Study Evaluating its Immunotherapy Candidate CV-301 in Bladder Cancer

KVISTGAARD, Denmark, April 28, 2014
- Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today the first
patient has now been treated in a randomized, prospective Phase 2 study of
its active immunotherapy candidate CV-301 in bladder cancer.

In the study, sponsored by the National Cancer Institute, 54 patients with
high grade non-muscle invasive bladder cancer whose cancer has progressed
after initial BCG (Bacillus Calmette-Guerin) treatment will be treated with
BCG alone or in combination with CV-301. BCG has been approved in many
countries to prevent the recurrence of superficial bladder tumors.

The study's primary endpoint is to determine if there is an improvement in
disease-free survival for patients receiving BCG treatment and CV-301
immunotherapy compared to those receiving BCG treatment alone. It is the
hypothesis that the combined administration of BCG and CV-301 may augment the
BCG-induced cytotoxic T lymphocyte response against bladder cancer cells
expressing MUC-1 and/or CEA and potentially reverse BCG failure in patients
that progressed following a prior induction course of the therapy. Lead
investigator for the study is Piyush K. Agarwal, M.D., Head, Bladder Cancer
Section, National Cancer Institute, NIH.

An abstract on this study, entitled "A Randomized, Prospective, Phase II Study
to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) given in
combination with PANVAC versus BCG given alone in Adults with High Grade
Non-Muscle Invasive Bladder Cancer (NMIBC) who failed at least 1 Induction
Course of BCG," has been accepted for presentation in the Trials in Progress
section at the 2014 ASCO Annual Meeting in Chicago, IL from May 30 to June 3.
Abstract #TPS4590. Poster Board: #157B. Presenter: Sam Joseph Brancato, M.D.

James B. Breitmeyer, President of Bavarian Nordic's Cancer Immunotherapy
Division said: "We are very pleased that development of our cancer
immunotherapy candidates is expanding further into new indications and new
combination approaches. We are hopeful that combination therapy with CV-301
will yield positive results for bladder cancer patients who currently face
limited treatment options."

Anders Hedegaard, President&CEO.

Contacts
Rolf Sass Sørensen, Vice President Investor Relations (EU). Phone +45 61 77 47
43
Seth Lewis, Vice President Investor Relations (US). Phone + 1 978-298-5654

About CV-301
CV-301 (formerly developed as PANVAC) is an immunotherapy product candidate
for the treatment of multiple cancers. It originates from the same poxvirus
technology platform as PROSTVAC.

Both PROSTVAC and CV-301 are prime-boost vaccines sequentially combining two
different poxviruses (vaccinia and fowlpox). Collectively, these two product
candidates, along with earlier generations of these vaccines, have been the
subject of over 30 clinical trials with more than 1,100 patients actively
treated for prostate, breast, lung, colorectal, gastric, pancreatic, ovarian
and other cancers. These extensive clinical studies suggest that the product
candidates are well-tolerated with the ability to induce specific immune
responses directed against the relevant tumor-associated antigens.

While PROSTVAC incorporates a single antigen over-expressed in prostate cancer
(PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are
over-expressed in other major cancers, including breast, colon, bladder and
other cancers, which makes CV-301 potentially applicable in various cancers.

About bladder cancer
In developed countries, more than 250,000 people are diagnosed every year with
bladder cancer. Approximately one third of the patients present with
high-grade non-muscular invasive bladder cancer, which is extremely difficult
to treat due to high recurrence and progression rates. The standard of care
is a single induction of intravesical BCG treatment followed by maintenance
therapy. Unfortunately, high recurrence rates of 50% lead to a significant
unmet need.

Bladder cancer is well known to respond to immunotherapy, and BCG was the
first modern immunotherapy to be approved in many countries to prevent the
recurrence of superficial bladder tumors. BCG is a vaccine against
tuberculosis that is prepared from attenuated (weakened) live bovine
tuberculosis bacillus that has lost its virulence in humans. BCG
immunotherapy is effective in up to 2/3 of the cases at this stage. The
mechanism by which BCG prevents recurrence is unknown, but may involve a
localized immune reaction which clears residual cancer cells.

Although a second induction course can be used in patients who fail a single
induction course of BCG, only 35% of patients who failed an initial induction
course will experience 12 month disease-free survival after receiving a
second induction course. For those patients failing a second induction
course, radical cystectomy with pelvic lymphadenectomy is the recommended
treatment, although it has a high morbidity rate and a small but real
mortality rate. Therefore, there is an unmet need for localized treatment for
patients who fail an initial induction course of BCG that can potentially
improve upon the poor results of a second induction course of BCG.

About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and
manufacturing novel cancer immunotherapies and vaccines for infectious
diseases. Lead product candidates are PROSTVAC®, an immunotherapy product
candidate for advanced prostate cancer that is the subject of an ongoing
pivotal Phase 3 clinical trial and IMVAMUNE®, a non-replicating smallpox
vaccine candidate in Phase 3 development, which is being developed and
supplied for emergency use to the U.S. Strategic National Stockpile under a
contract with the U.S. Government. The vaccine is approved in Canada under
the trade name IMVAMUNE and in the European Union under the trade name
IMVANEX®.

Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol
BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored
Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.

For more information, visitwww.bavarian-nordic.com.

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.

201408uk
http://hugin.info/100065/R/1780280/608600.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bavarian Nordic A/S via Globenewswire

HUG#1780280

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