Bavarian Nordic Completes Delivery of 20 Million Doses of IMVAMUNE® Smallpox Vaccine to the U.S. Strategic National Stockpile

KVISTGAARD, Denmark, November 15, 2013 /PRNewswire/ --

Bavarian Nordic A/S (OMX: BAVA) announced today that it completed the delivery of 20 million doses of IMVAMUNE^® smallpox vaccine to the U.S. Strategic National Stockpile (SNS) for use in the event of a smallpox emergency in the U.S.

This order completion is the result of a decade-long research and development partnership between Bavarian Nordic and the U.S. government and fulfills the original contract awarded in 2007, valued at USD 549 million.

"Bavarian Nordic is proud to be a part of fulfilling a US government requirement for bioterrorism preparedness by delivering 20 million doses of IMVAMUNE," said Anders Hedegaard, President and CEO of Bavarian Nordic. "This accomplishment shows that when resources and commitment are applied, industry and government can successfully work together to achieve great things."

Since 2010, Bavarian Nordic has been delivering the vaccine to the SNS.  It is being stockpiled for emergency use in individuals with compromised immune systems, such as people with HIV or atopic dermatitis, including children and pregnant and nursing women, who are not recommended to take the previous generation vaccine due to increased risk for severe side effects.

In April, the U.S. government awarded Bavarian Nordic a new contract valued at up to USD 228 million to supply 8 million additional doses of IMVAMUNE needed to maintain the 20 million dose stockpile over time.

About Bavarian Nordic's Partnership with the U.S. Government

Bavarian Nordic initiated the development of IMVAMUNE in 1999. After the U.S. terrorist attacks of 2001, the government expanded its investment in medicines and vaccines to protect against potential bioterrorism agents, by establishing the Project BioShield initiative.  

The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS), manages Project BioShield and is responsible for working with biotechnology and pharmaceutical companies to develop and stockpile effective medicines and vaccines against bioweapons, pandemic influenza, and other emerging infectious diseases.

Although smallpox was eradicated worldwide, the government considers it a high-priority bioterrorism threat.  While traditional, replicating smallpox vaccines have been effective in eradicating the disease, they are not recommended for up to 25 percent of the population due to the risk of adverse events, including death and severe disability. Therefore, the U.S. government initiated a program to develop and procure a smallpox vaccine suitable for this special population.

IMVAMUNE is a non-replicating vaccine that, unlike traditional vaccines, cannot spread in the vaccinated person. Therefore, none of the serious side effects normally associated with traditional vaccines have been seen with IMVAMUNE.  

In 2003 and 2004, Bavarian Nordic received two contracts from the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the clinical development of IMVAMUNE.  In 2007, BARDA awarded the company a procurement contract to supply 20 million doses of the vaccine.  

In April 2013, BARDA awarded Bavarian Nordic a new contract valued at up to USD 228 million to supply 8 million additional doses of IMVAMUNE needed to maintain the 20 million dose stockpile over time. The first USD 110 million of the new order is secured, and the remaining portion will be secured based on availability of funds in 2014.

The company is continuing its work with BARDA on an enhanced freeze dried vaccine formulation, which is expected to increase flexibility for use in an emergency and reduce stockpiling costs based on a longer shelf life.  

IMVAMUNE has also been supplied to other government stockpiles around the world. Earlier this year, the vaccine was approved in the European Union under the trade name IMVANEX^®. In the U.S., registration studies are currently ongoing.

About Bavarian Nordic

Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC^®, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial and IMVAMUNE, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. IMVAMUNE is approved in the European Union under the trade name IMVANEX.

Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.

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.

Contacts

Anders Hedegaard, President & CEO. Phone +45-23-20-30-64

Paul Chaplin, President, Infectious Diseases Division.  Phone +1-202-288-9220

SOURCE Bavarian Nordic A/S