Bavarian Nordic Receives European Marketing Authorization for IMVANEX Smallpox Vaccine
(Thomson Reuters ONE) -
* First smallpox vaccine granted market authorization in all EU member states
* First MVA-BN®-based product approval
KVISTGAARD, Denmark, August 7, 2013 - 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). The authorization covers all 27
European Union member states and European Economic Area countries Iceland,
Liechtenstein and Norway.
IMVANEX will be made available for governments to purchase and use in accordance
with official national recommendations.
"The marketing authorization of IMVANEX marks a significant milestone for our
company and our MVA-BN vaccine technology platform, which we have taken from
early research through regulatory approval and 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, and we look forward to working with the European
governments to address the requirements for their national preparedness plans,
focusing on the advantages that IMVANEX brings in terms of safety and
administration for people at risk."
IMVANEX is the only smallpox vaccine approved through the centralized procedure
and available to all EU member states. Known as IMVAMUNE® in the U.S., it has
been developed under contracts with the U.S. Government. To-date, Bavarian
Nordic has manufactured and delivered 17 million doses of 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. IMVANEX has
also been supplied to other government stockpiles around the world.
Asger Aamund
Chairman of the Board
Contacts
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About IMVANEX (MVA-BN)
MVA-BN (Modified Vaccinia Ankara - Bavarian Nordic) 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
IMVANEX) 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.
An advantage of MVA-BN is the virus' inability to replicate in a vaccinated
individual. The replication cycle is blocked at a very late stage, which ensures
that new viruses are not generated and released. 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.
Bavarian Nordic operates its own commercial-scale multi-purpose manufacturing
facility in Denmark that is designed for the manufacture of MVA-BN-based and
other poxvirus-based vaccines.
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 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.
201316uk:
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1721716]
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Datum: 07.08.2013 - 14:52 Uhr
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News-ID 285571
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