Bavarian Nordic Announces Initiation of Safety and Immunogenicity Study of Ebola Vaccine Regimen in Sierra Leone - Seite 2

The EBOVAC-Salone study is being initiated on a parallel track with multiple ongoing Phase 1 and 2 studies that are being conducted across the U.S., Europe and Africa as part of the accelerated development plan for the Ebola vaccine regimen. First-in-human Phase 1 clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in January 2015, followed by several sites in Africa. In May 2015, Janssen presented positive preliminary data from the UK Phase 1 study to the U.S. Food and Drug Administration. A Phase 2 study, being carried out in the UK and France, started in July 2015 with a second multi-site Phase 2 study planned to shortly commence in several West and East African countries.

With nearly 14,000 people infected by Ebola, Sierra Leone accounts for the largest number of cases in any of the West African countries affected by the outbreak that has raged since 2014. In total, more than 28,000 people have been infected with the virus in the region and more than 11,000 people have died. Although only few new cases have been reported over the past months, Sierra Leone along with Guinea remains yet to be declared Ebola-free.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: [phone]

Seth Lewis
Vice President Investor Relations (US)
Tel: [phone]

About MVA-BN Filo
MVA-BN Filo is Bavarian Nordic's multivalent vaccine candidate designed to protect against Ebola Zaire, Ebola Sudan and Marburg viruses. The vaccine candidate was originally developed in collaboration with the U.S. National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health (NIH) who also headed the preclinical investigation of the Ad26.ZEBOV/MVA-BN Filo prime-boost vaccine regimen.

MVA-BN Filo is developed using Bavarian Nordic's proprietary vaccine platform technology, MVA-BN, which is also employed in the Company's smallpox vaccine, IMVAMUNE^® (approved in EU and Canada under the trade name IMVANEX^®). To-date, Bavarian Nordic has produced and delivered 28 million doses of the smallpox vaccine for emergency use to the U.S. Strategic National Stockpile.

In October 2014, Bavarian Nordic and Janssen entered into a global license and a supply agreement for MVA-BN Filo. This was part of an overall commitment made by Johnson & Johnson to accelerate and significantly expand the production of the preventative Ebola vaccine program in development at its Janssen Pharmaceutical Companies. To date, Bavarian Nordic has produced and delivered the bulk equivalent of over one million doses of its vaccine to Janssen.