Bavarian Nordic Announces FDA Acceptance and Priority Review of Biologics License Application for MVA-BN Smallpox Vaccine - Seite 2

Bavarian Nordic has to-date delivered 28 million doses of the liquid-frozen MVA-BN smallpox vaccine to the U.S. Strategic National Stockpile for emergency use in people with compromised immune systems. The Company has ongoing contracts with the Biomedical Advanced Research and Development Authority (BARDA) to replenish the stockpile, which has expired, with a freeze-dried formulation of the vaccine. In 2019, the Company will initiate a Phase 3 lot consistency study of the freeze-dried formulation to support the approval of this formulation.

Federal funding acknowledgments
The Phase 3 program 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 of innovative and safer therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our MVA-BN non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union and in Canada (under the trade names IMVANEX and IMVAMUNE respectively). In addition to our long-standing collaboration with the U.S. government on the development of medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.