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

COPENHAGEN, Denmark, December 21, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN for active immunization against smallpox in adults age 18 years and older. The FDA has granted priority review to the BLA, which means that the agency is targeting completion of the review in six months rather than the standard time of ten months. Priority review is granted by the FDA to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. If approved, MVA-BN would be the first and only approved non-replicating smallpox vaccine in the U.S. 

"The acceptance of our BLA is a significant milestone for Bavarian Nordic, and for our long-standing collaboration with the U.S. Government on the development of MVA-BN to address public health threats, such as smallpox," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "While MVA-BN has already been approved in the EU and in Canada, an FDA approval would represent an important acknowledgment of our core platform technology, which we are actively investigating across multiple infectious disease and cancer indications." 

The regulatory submission for the MVA-BN smallpox vaccine is based on a comprehensive development program, comprising 22 clinical studies, including two Phase 3 studies, the latter of which showed non-inferiority of MVA-BN compared to ACAM2000, the current U.S. licensed, replicating smallpox vaccine. In addition, no serious adverse events related to MVA-BN were reported, and the frequency of Grade 3 or higher related adverse events was less in MVA-BN (1.2%) in comparison to the replicating smallpox vaccine (10.3%). 

If approved, Bavarian Nordic would also be eligible to receive a Priority Review Voucher, which provides incentives to developers of medical countermeasures among others. The voucher can be used to accelerate the review of a future BLA and is also transferrable. The Company intends to sell the voucher to a third party. 

About the MVA-BN Smallpox Vaccine
The MVA-BN smallpox vaccine is based on a live, attenuated vaccinia virus, unable to replicate in humans. The liquid-frozen version of the vaccine is currently approved in the EU under the trade name IMVANEX for active immunization against smallpox of the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis), and in Canada under the trade name IMVAMUNE for active immunization against smallpox in a public health emergency of persons 18 years of age and older who are contraindicated to replicating smallpox vaccines. The regulatory approval in these territories were based on Phase 2 clinical data.