Bavarian Nordic Completes Enrollment of Phase 3 Non-inferiority Study of IMVAMUNE® Smallpox Vaccine

  • Second and final Phase 3 study to support a U.S. registration of liquid-frozen IMVAMUNE

COPENHAGEN, Denmark, November 23, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the completion of enrollment of a Phase 3 clinical study designed to demonstrate non-inferiority between its investigational, non-replicating smallpox vaccine, IMVAMUNE and ACAM2000, the current U.S. licensed, and replicating smallpox vaccine. This is the second and final study agreed with the U.S. Food and Drug Administration (FDA) to support the registration of liquid-frozen IMVAMUNE. The first study, a lot consistency study in 4,000 healthy individuals, was successfully completed in 2015.

The Phase 3 non-inferiority study enrolled 440 subjects at a U.S. military garrison in South Korea led by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the U.S. Defense Health Agency. All subjects will have completed the study within second quarter of 2017, and top line data is anticipated in the second half of 2017.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "Completion of enrolment of this study represents a significant milestone in the collaboration between Bavarian Nordic, and multiple federal agencies. IMVAMUNE has served as the cornerstone for our Company over the past decade and we will continue to work with the U.S. Government to meet their stated goal of protecting 66 million Americans who are in need of a safer smallpox vaccine. We look forward reporting these data and working with the authorities in the process towards U.S. licensure."

Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile.

Federal funding acknowledgments
The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200700034C

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 visit 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.

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. 30 / 2016