Bavarian Nordic Receives European Marketing Authorization for IMVANEX Smallpox Vaccine

KVISTGAARD, Denmark, August 7, 2013 /PRNewswire/ --

• First product approved using MVA-BN^® vaccine platform technology
• In Phase 3 development in the U.S. under trade name IMVAMUNE^® and supplied to the U.S. Strategic National Stockpile

Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has granted marketing authorization for IMVANEX^® (MVA-BN) for active immunization against smallpox disease for the general adult population, including people with weakened immune systems (people diagnosed with HIV or atopic dermatitis).  This is the first European approval of a novel biodefense vaccine developed through a successful public-private partnership with the U.S. government.

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"The marketing authorization of IMVANEX marks a significant milestone for our company and our MVA-BN vaccine technology platform, which now serves as the foundation for multiple candidates in our development pipeline," said Anders Hedegaard, President and CEO of Bavarian Nordic. "We are delighted to receive our first regulatory product approval, which was supported by a strong partnership with the U.S. government and proves that public-private enterprises can work if there is a shared vision and willingness to invest in a sustained biodefense market."

IMVANEX is the only smallpox vaccine approved through the centralized European Union procedure. Known as IMVAMUNE^® in the U.S., it has been developed under contracts with the U.S. government.  Since 2010,  Bavarian Nordic has been delivering the vaccine to the U.S. Strategic National Stockpile for emergency use in immune compromised individuals, such as people with atopic dermatitis and HIV who are not recommended to receive conventional, replicating smallpox vaccines. IMVAMUNE/IMVANEX has also been supplied to other government stockpiles around the world.

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

Bavarian Nordic initiated the development of MVA-BN (trade name IMVAMUNE in the U.S. and IMVANEX in Europe) in 1999 and began the first clinical study in 2001.  After the U.S. terrorist attacks of 2001, the U.S. government expanded its investment in medicines and vaccines to protect against potential bioterrorism agents, such as smallpox.

Security experts-including the U.S. Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism-expect that an act of biological terrorism is more likely than nuclear terrorism.  Although smallpox was eradicated worldwide by 1980, the U.S. government considers it a high-priority bioterrorism threat.

Traditional smallpox vaccines, made from a live replicating form of the vaccinia virus, have been effective in preventing the disease.  However, they are not recommended for 25 percent of the population due to the risk of adverse events, including death and severe disability - this includes people diagnosed with HIV and atopic dermatitis or their household contacts.  Therefore, the U.S. government initiated a program to develop a smallpox vaccine for these individuals.

MVA-BN is a non-replicating strain of vaccinia virus that, unlike traditional vaccines, does not have the ability to replicate in a vaccinated individual.  This means that the virus cannot spread in the vaccinated person and none of the serious side effects normally associated with replicating vaccinia viruses have been seen with MVA-BN.  

While Bavarian Nordic has made significant investments in the development of MVA-BN, in particular the building of a commercial manufacturing facility, the majority of the development costs have been supported by the U.S. Department of Human Health Services - both the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA).  

Contracts with NIAID in 2003 and 2004 and other NIAID resources funded much of the product development work and nearly all of the clinical development that underpinned the European marketing application.  Advanced development and manufacturing of MVA-BN was successfully transitioned to BARDA with a Project BioShield procurement contract in 2007.  Currently, a national stockpile sufficient to protect 10 million Americans is being delivered.  BARDA is now supporting Bavarian Nordic to further improve the vaccine by developing a freeze-dried version that may have a longer shelf life, reduced storage costs, and simplified transportation logistics compared to the current formulation.

About MVA-BN Platform Technology

MVA-BN (Modified Vaccinia Ankara - Bavarian Nordic) is a robust and adaptable vaccine platform suitable for addressing a wide variety of infectious diseases. In addition to developing MVA-BN 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. Almost 5,800 individuals, nearly 1,000 of whom are immunocompromised, have been vaccinated with MVA-BN-based vaccines, showing the platform displays high immunogenicity and a favorable safety profile.  The U.S. Department of Homeland Security and NIAID are funding the development of MVA-BN-based vaccines for other high priority bioterrorism threats - Foot and Mouth Disease, and Marburg.

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 operates its own flexible, multi-purpose manufacturing facility that is designed for the manufacture of IMVAMUNE/IMVANEX, as well as other MVA-BN-based and poxvirus-based vaccines at a commercial scale.

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