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2016-10-18

Bavarian Nordic A/S: Bavarian Nordic Announces Initiation of Phase 2 Clinical Trial of RSV Vaccine

* First Phase 2 study will evaluate prime-boost vaccine approach in elderly
population

COPENHAGEN, Denmark, October 18, 2016
- Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the initiation
of the first Phase 2 clinical study of MVA-BN® RSV, its novel, broad
spectrum, vaccine candidate against RSV (respiratory syncytial virus).

The study, which is being conducted in USA, will enrol 400 healthy subjects,
aged 55 or older who will be randomized into five groups of 80 subjects each.
Subjects will receive two administrations four weeks apart of either low or
high doses of MVA-BN RSV and/or placebo, in order to identify the optimal
dose and schedule for future studies. More information on the trial can be
found athttp://www.clinicaltrials.gov/ct2/show/NCT02873286.

Top-line results from the study are anticipated around mid-2017 and will
provide important information for a subsequent Phase 2b field efficacy study,
which is planned for initiation later in 2017.
Paul Chaplin, President&Chief Executive Officer of Bavarian Nordic, said:
"Advancing our RSV program into Phase 2 is an important milestone for
Bavarian Nordic in our efforts to develop a vaccine which potentially offers
broad protection against the virus. RSV remains an area of high unmet medical
need with no approved vaccine available. This Phase 2 study represents an
essential step in the successful development of any vaccine; to ensure we
establish an ideal dose and dosing regimen, prior to exploring this candidate
in larger studies. In this study we will evaluate both a single vaccination,
as well as a prime-boost approach that will determine which regime induces
prolonged immune responses against RSV "

MVA-BN RSV represents a new vaccine approach specifically designed to target
five different RSV proteins to ensure a broad immune response against both
RSV subtypes (A&B). Extensive preclinical studies have shown that MVA-BN RSV
induces a balanced immune response comprised of both antibodies and T cells,
in a similar fashion to the natural response to an RSV infection. These
results were confirmed in a Phase 1 study in healthy adults, reported in May
2016, which showed that MVA-BN RSV significantly boosted antibodies and T
cells against both RSV subtypes. The vaccine was well tolerated, with no
unexpected or serious adverse reactions. The vast majority of events
represented local and systemic reactions typical for vaccines.

About RSV
Respiratory syncytial virus, or RSV, is the most common cause of bronchiolitis
and pneumonia in infants and a significant cause of respiratory illness in
older adults, resulting in a high number of hospitalizations. RSV infections
are responsible each year for a similar number of deaths as the flu in
children up to age 14, as well as in the elderly population. It is estimated
that more than 64 million people are infected globally each year, yet unlike
the flu, there is no vaccine to prevent RSV, presenting a large unmet medical
need and market opportunity.

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development, manufacturing and commercialization of cancer immunotherapies
and vaccines for infectious diseases, based on the Company's live virus
vaccine platform. Through long-standing collaborations, including a
collaboration with the U.S. government, Bavarian Nordic has developed a
portfolio of vaccines for infectious diseases, including the non-replicating
smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the
United States and other governments. The vaccine is approved in the European
Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its
partner Janssen are developing an Ebola vaccine regimen, which has been
fast-tracked, with the backing of worldwide health authorities, and a vaccine
for the prevention and treatment of HPV. Additionally, in collaboration with
the National Cancer Institute, Bavarian Nordic has developed a portfolio of
active cancer immunotherapies, including PROSTVAC®, which is currently in
Phase 3 clinical development for the treatment of advanced prostate cancer.
The company has partnered with Bristol-Myers Squibb for the potential
commercialization of PROSTVAC. For more information
visitwww.bavarian-nordic.comor follow us on Twitter@bavariannordic.

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. All
such forward-looking statements are expressly qualified by these cautionary
statements and any other cautionary statements which may accompany the
forward-looking statements. 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.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271

Company Announcement no. 27 / 2016

2016-27-en
http://hugin.info/100065/R/2049677/766528.pdf

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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

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