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Bavarian Nordic Applauds Announcement of Positive Data for Ebola Vaccine Regimen Published in JAMA

  • Ebola vaccine regimen produced an antibody response in 100 percent of healthy volunteers that was sustained 8 months following immunization, indicating potential for a durable response

COPENHAGEN, Denmark, April 19, 2016 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) confirms that a public-private partnership of some of the world’s leading health organizations today announced that data from a Phase 1 study of a preventive Ebola vaccine regimen have been published in JAMA: The Journal of the American Medical Association. The results, the first published on the vaccine regimen, suggest that the regimen was well-tolerated by healthy volunteers and did not result in any vaccine-related serious adverse events. 

While 97 percent of the trial participants generated antibodies specific to Ebola four weeks after a priming dose with AdVac, these immune responses were enhanced by administration of the MVA-BN booster dose, with 100 percent of participants generating Ebola-specific antibodies at 21 days post-boost, and 79-100 percent showing T cell responses depending on the dosing interval, thus validating the prime-boost concept. 

Notably, eight months following prime vaccination, 100 percent of individuals in the study maintained Ebola-specific antibodies, while vaccine-induced T cell responses persisted in 77-80 percent of those receiving the AdVac/MVA-BN regimen. 

The article titled “Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines A Randomized Clinical Trial” is published online at http://jama.jamanetwork.com/article.aspx?articleid=2514196

The Phase 1 study was led by the Oxford Vaccine Group at the University of Oxford Department of Paediatrics and took place in the United Kingdom. The study tested a vaccine regimen containing two components based on, respectively, AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and MVA-BN® technology from Bavarian Nordic. Healthy volunteers were given one vaccine dose to prime their immune system, and then the alternative vaccine to boost their immune response, with the goal of evaluating the duration of immunity. Prime-boost vaccination is an established approach for the prevention of several infectious diseases. 

The study provides the first set of data from a total of 10 Phase 1, 2 and 3 clinical studies that are being conducted on a parallel track across the U.S., Europe and Africa in support of potential eventual registration for the Ebola vaccine regimen. 

For additional information, see press release from the EBOVAC1 IMI2 Consortium at http://www.jnj.com/news/all/Global-Public-Private-Partnership-Announces-Publication-of-Positive-Phase-1-Data-for-Ebola-Vaccine-Regimen-in-JAMA

About the Ebola Vaccine Regimen
The Ebola vaccine regimen is being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Bavarian Nordic. The regimen was first discovered in a collaborative research program with the U.S. National Institutes of Health (NIH). Clinical studies have been supported by grants awarded by Europe’s Innovative Medicines Initiative (IMI) to a consortium of leading global research institutions working with Janssen, which includes the London School of Hygiene & Tropical Medicine, the University of Oxford and Inserm, the French National Institute of Health and Medical Research.

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 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 visit www.bavarian-nordic.com or 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

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