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

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 @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


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Source: Bavarian Nordic A/S via Globenewswire

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