Bavarian Nordic Announces that Janssen has completed a Submission for Emergency Use Assessment and Listing for its Ebola Vaccine Regimen to the World Health Organization
(Thomson Reuters ONE) -
* Preparations also underway to initiate first-in-human study for multivalent
vaccine regimen to combat Ebola, Sudan and Marburg viruses
COPENHAGEN, Denmark, September 12, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) announced today that Janssen Vaccines & Prevention B.V. (Janssen) has
completed a submission to the World Health Organization (WHO) for Emergency Use
Assessment and Listing (EUAL) for its investigational preventive Ebola prime-
boost vaccine regimen, which includes Bavarian Nordic's MVA-BN(®) Filo vaccine.
The EUAL is a special procedure that can be implemented when there is an
outbreak of a disease with high rates of morbidity or mortality and a lack of
treatment or prevention options.
EUAL assists UN Member States and procurement agencies determine the
acceptability for use of a specific vaccine in a public health emergency. The
decision to grant EUAL to the investigational vaccine regimen will be based on
an evaluation of available data including quality, safety, and immunogenicity,
as well as a risk/benefit analysis. While EUAL potentially allows for deployment
of a vaccine in an emergency, the vaccine remains investigational pending formal
regulatory agency review and approval.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We
applaud Janssen's continued efforts to advance the development of the Ebola
vaccine regimen. Although we are no longer in an outbreak situation, the scale
and impact of the recent Ebola epidemic in West Africa has clearly demonstrated
that the world needs to be prepared in case of future outbreaks."
The first clinical data for the investigational Janssen vaccine regimen among
healthy volunteers were published in JAMA: The Journal of the American Medical
Association in April 2016. The Phase 1 results from a UK study suggested that
the regimen was well-tolerated and immunogenic (produced an immune response).
The study found that 100 percent of study participants achieved an initial
antibody response to Ebola, and that this was sustained eight months following
vaccination among all volunteers.
The UK study provided the first set of data from a total of 10 clinical studies
that are being conducted on a parallel track across the U.S., Europe and Africa
in support of potential full licensure for the Ebola vaccine regimen. The first
study of the vaccine regimen in a West African country affected by the Ebola
epidemic began in Sierra Leone in October 2015.
Janssen is also preparing to initiate a first-in-human Phase 1 clinical study to
test a second-generation, multivalent version of the AdVac/MVA-BN vaccine
regimen. The multivalent heterologous prime-boost regimen is intended to protect
against multiple filoviruses that cause disease in humans, including the Ebola,
Sudan and Marburg viruses. The U.S. study will test the safety, tolerability and
immunogenicity of this vaccine regimen in varying dosing schedules among healthy
volunteers. The National Institute of Allergy and Infectious Diseases (NIAID),
part of the U.S. National Institutes of Health (NIH), is funding this study.
More information on the study can be found at
https://clinicaltrials.gov/ct2/show/NCT02860650.
About the Ebola Vaccine Regimen
The monovalent Ebola vaccine regimen and multivalent Ebola, Sudan and Marburg
vaccine regimen are being developed by Janssen in collaboration with Bavarian
Nordic. The regimens originate from a collaborative research program with the
National Institutes of Health (NIH) that commenced in 2008. The program has been
funded in part with Federal funds 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.
Clinical development, manufacturing and deployment have been supported by grants
totaling more than ?100 million awarded in 2015 by Europe's Innovative Medicines
Initiative (IMI) to a consortium of leading global research institutions working
with Janssen. Additionally, $28.5 million was awarded in 2015 by the Biomedical
Advanced Research and Development Authority (BARDA), part of the U.S. Department
of Health and Human Services, to help accelerate the development of the
monovalent Ebola vaccine regimen under Contract Number HHSO100201500008C.
Bavarian Nordic and Janssen have rapidly scaled up production of the monovalent
Ebola vaccine regimen and now have approximately 2 million regimens available,
with the capacity to produce several million regimens if needed.
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 Janssen are developing
an Ebola vaccine regimen, which was 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 visit www.bavarian-nordic.com or follow us on Twitter
(at)bavariannordic.
Forward-looking statement
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
Press Release
2016-09-12-en:
http://hugin.info/100065/R/2041418/761768.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 12.09.2016 - 18:01 Uhr
Sprache: Deutsch
News-ID 494219
Anzahl Zeichen: 8267
contact information:
Town:
Kvistgård
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 206 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Bavarian Nordic Announces that Janssen has completed a Submission for Emergency Use Assessment and Listing for its Ebola Vaccine Regimen to the World Health Organization"
steht unter der journalistisch-redaktionellen Verantwortung von
Bavarian Nordic A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
