Bavarian Nordic's MVA-BN® Vaccine Platform Receives Additional Support From U.S. Government

Two new contracts totaling $18.9 million will advance vaccine development programs for key Defense and Homeland Security threats

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Bavarian Nordic A/S

Nov 14, 2012, 08:00 ET

KVISTGÅRD, Denmark, November 14, 2012 /PRNewswire/ --

Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that the U.S. Department of Homeland Security (DHS) Science and Technology Directorate and the National Institutes of Health (NIH) have awarded the company two new contracts valued at up to $18.9 million for the development of recombinant Modified Vaccinia virus Ankara (MVA)-based vaccines, building on the company's MVA-BN^® platform. The NIH contract, valued at up to $17.9 million, supports the advanced development of a MVA-BN^®-based human vaccine against the viral hemorrhagic fever Marburg, as well as the evaluation of novel technologies to enhance efficacy. The DHS contract, valued at nearly $1 million, supports the development of a MVA-BN^®-based animal vaccine against Foot-and-mouth disease.

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"These new contracts demonstrate the versatility of our MVA-BN platform for infectious disease vaccines and cancer immunotherapeutics," said Anders Hedegaard, President and CEO of Bavarian Nordic A/S. "The MVA-BN platform has broad applicability, an excellent safety profile and established manufacturing capacity, making it one of the most attractive vaccine technologies to meet the U.S. government's preparedness needs, as well as demonstrating commercial value."

MVA-BN^® is a robust and adaptable vaccine platform suitable for addressing a wide variety of infectious diseases, including biological threats. In addition to developing MVA-BN^® (trade name IMVAMUNE^®) as a safer smallpox vaccine essential to protecting the immune-compromised population, Bavarian Nordic has conducted preclinical and clinical studies of recombinant MVA-BN^®-based vaccines for a variety of infectious diseases and numerous types of cancer. Studies including more than 3,400 subjects suggest that MVA-BN^®-based vaccines have a favorable safety profile that could support use in the diverse U.S. population.

These new contracts build on a successful partnership between Bavarian Nordic and the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). These agencies have supported the development, manufacture and stockpiling of IMVAMUNE^® smallpox vaccine. As part of that partnership, Bavarian Nordic has built and operates an industrial scale manufacturing facility that currently produces and delivers IMVAMUNE^® to the Strategic National Stockpile. This flexible manufacturing capability significantly reduces the cost and risk associated with producing recombinant MVA-BN^®-based vaccine candidates.

The development of IMVAMUNE^® has been supported by federal funds from the National Institutes of Health under contract No. HHSN266200400072C and the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract No. HHSO100200700034C.

The Marburg development program is being supported by federal funds from the National Institutes of Health under contract No. HHSN272201200018C. The foot-and-mouth disease program is being supported by federal funds from the Department of Homeland Security under contract No. HSHQDC-12-C-00051.

About Marburg and Foot-and-mouth disease

The Marburg virus is a highly contagious virus that produces severe and often deadly viral hemorrhagic fever in humans. Viral hemorrhagic fevers, including the Marburg filovirus, are classified by the U.S. government as Category A bioterrorism agents and have the potential to pose a risk to national security. The development of effective vaccines against viral hemorrhagic fevers like Marburg is a high priority for the U.S. Department of Defense Chemical and Biological Defense Program.

Foot-and-mouth disease (FMD) is a severe disease of cattle, sheep, swine and other cloven-hoofed animals. FMD remains one of the most feared agricultural pathogens due to the severe adverse impact on animal production and productivity. Concerns regarding the accidental or intentional introduction of FMD virus into FMD-free countries have led to efforts by the U.S. Department of Agriculture and Department of Homeland Security to identify novel FMD vaccines that address limitations of currently available inactivated FMD vaccines.

Both the Marburg virus and FMD virus are classified as Select Agents by the U.S. Government.

For more information, visit http://www.bavarian-nordic.com

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. 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.