Du är här

2015-10-09

Bavarian Nordic A/S: Bavarian Nordic Announces Initiation of Safety and Immunogenicity Study of Ebola Vaccine Regimen in Sierra Leone

* First study of the Ad26.ZEBOV/MVA-BN® Filo prime-boost vaccination regimen
in an Ebola outbreak country
* Study being initiated on parallel track with multiple ongoing Phase 1 and 2
studies across U.S., Europe and Africa to support licensure of the vaccine
regimen

COPENHAGEN, Denmark, October 9, 2015
- Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today the initiation
of a new clinical study of the Ebola prime-boost vaccine regimen that
combines Bavarian Nordic's MVA-BN®Filo vaccine with the Ad26.ZEBOV vaccine
from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of
Johnson&Johnson (Janssen). The study called 'EBOVAC-Salone' is being
conducted in Sierra Leone's Kambia district, where some of the country's most
recent Ebola cases have been reported. The first volunteers have received
their initial vaccine dose.

The study, coordinated by the London School of Hygiene&Tropical Medicine and
sponsored by Janssen, is designed to evaluate the safety and immunogenicity
of the combination regimen. Volunteers will first be given the Ad26.ZEBOV
dose to prime their immune system, and then the MVA-BN Filo dose at a later
date to boost their immune response, with the goal of creating stronger and
longer-lasting immunity. The first stage of the study, which has now been
initiated, includes approximately 40 adults aged 18 years or older. In stage
2, approximately 400 individuals across different age groups will be
vaccinated, including children and adolescents. Additional stages are being
finalized in consultation with the Sierra Leonean authorities and
international health agencies. Further details of the study can be found
athttp://clinicaltrials.gov/ct2/show/NCT02509494.

Paul Chaplin, President&Chief Executive Officer of Bavarian Nordic, said: "The
initiation of EBOVAC-Salone marks an important milestone for our joint
program with Janssen. It is a significant step forward in the development of
a vaccine against Ebola. It is remarkable how far the program has moved,
which has only been possible due to the commitment and dedication shown by
both Janssen and our employees in terms of the progress we have made in
manufacturing bulk vaccine for almost 2 million doses and initiating this
study within a year of joining forces. The key attributes of both the MVA-BN
and Ad26 technologies were initially recognized through NIH funding and
subsequently the program has benefited from additional governmental funding.
We believe our progress to date highlights the potential for a successful
model of private-public partnerships in the development of products
addressing unmet medical needs for the future."

The EBOVAC-Salone study is being initiated on a parallel track with multiple
ongoing Phase 1 and 2 studies that are being conducted across the U.S.,
Europe and Africa as part of the accelerated development plan for the Ebola
vaccine regimen. First-in-human Phase 1 clinical studies of the prime-boost
vaccine regimen began in the United Kingdom and United States in January
2015, followed by several sites in Africa. In May 2015, Janssen presented
positive preliminary data from the UK Phase 1 study to the U.S. Food and Drug
Administration. A Phase 2 study, being carried out in the UK and France,
started in July 2015 with a second multi-site Phase 2 study planned to
shortly commence in several West and East African countries.

With nearly 14,000 people infected by Ebola, Sierra Leone accounts for the
largest number of cases in any of the West African countries affected by the
outbreak that has raged since 2014. In total, more than 28,000 people have
been infected with the virus in the region and more than 11,000 people have
died. Although only few new cases have been reported over the past months,
Sierra Leone along with Guinea remains yet to be declared Ebola-free.

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

About MVA-BN Filo

MVA-BN Filo is Bavarian Nordic's multivalent vaccine candidate designed to
protect against Ebola Zaire, Ebola Sudan and Marburg viruses. The vaccine
candidate was originally developed in collaboration with the U.S. National
Institute of Allergy and Infectious Diseases, part of the U.S. National
Institutes of Health (NIH) who also headed the preclinical investigation of
the Ad26.ZEBOV/MVA-BN Filo prime-boost vaccine regimen.

MVA-BN Filo is developed using Bavarian Nordic's proprietary vaccine platform
technology, MVA-BN, which is also employed in the Company's smallpox vaccine,
IMVAMUNE®(approved in EU and Canada under the trade name IMVANEX®). To-date,
Bavarian Nordic has produced and delivered 28 million doses of the smallpox
vaccine for emergency use to the U.S. Strategic National Stockpile.

In October 2014, Bavarian Nordic and Janssen entered into a global license and
a supply agreement for MVA-BN Filo. This was part of an overall commitment
made by Johnson&Johnson to accelerate and significantly expand the production
of the preventative Ebola vaccine program in development at its Janssen
Pharmaceutical Companies. To date, Bavarian Nordic has produced and delivered
the bulk equivalent of over one million doses of its vaccine to Janssen.

Funding acknowledgments

In January 2015, Europe's Innovative Medicines Initiative (IMI) awarded a
consortium of leading global research institutions and non-government
organizations working in conjunction with the Janssen Pharmaceutical
Companies grants totaling more than €100 million from the Ebola+ program to
support the development, manufacturing and deployment of the vaccine regimen.
The EBOVAC1 and EBODAC consortia partners also include the London School of
Hygiene&Tropical Medicine, University of Oxford, Inserm, Grameen Foundation
and World Vision of Ireland. The EBOVAC-Salone study is funded under
Innovative Medicines Initiative 2 Joint Undertaking grant agreement EBOVAC1
(grant no. 115854) and EBODAC (grant no. 115847), part of the Ebola+ program
launched in response to the Ebola virus disease outbreak. This Innovative
Medicines Initiative 2 Joint Undertaking receives support from the European
Union's Horizon 2020 research and innovation program and EFPIA.

The investigational Ebola vaccine regimen was discovered in a collaborative
research program with the National Institutes of Health (NIH). This program
received direct funding and preclinical services from the National Institute
of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract
Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I,
respectively. The MVA-BN-Filo material used in phase 1 studies was produced
under NIAID/Fisher BioServices contract #FBS-004-009 and NIH contract
HHSN272200800044C.

About Bavarian Nordic

Bavarian Nordic is a biopharmaceutical company focused on the development and
manufacturing of cancer immunotherapies and vaccines for infectious diseases.
Through a long-standing collaboration with the U.S. Government, Bavarian
Nordic has developed a portfolio of biological countermeasures, including the
non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for
emergency use by the U.S. and other governments. The vaccine is approved in
the EU (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its
partner Janssen are pioneering the development of an Ebola vaccine regimen,
which has been fast-tracked by authorities in response to the current
situation in West Africa. Additionally, in collaboration with the National
Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer
immunotherapies based on its versatile pox-virus based technologies,
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. 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.

201528en
http://hugin.info/100065/R/1957804/713357.pdf

---------------------------------------

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#1957804

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.