Bavarian Nordic's IMVANEX® Smallpox Vaccine Receives Positive Opinion from European Regulatory Authorities
ET | Source:Bavarian Nordic A/S
KVISTGAARD, Denmark, May 31, 2013 - Bavarian Nordic A/S (OMX: BAVA) announced
today that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion recommending the
granting of a marketing authorization for IMVANEX® for active immunization
against smallpox disease for the general adult population, including people with
immunodeficiencies (people diagnosed with HIV or atopic dermatitis).
IMVANEX, a non-replicating smallpox vaccine known as IMVAMUNE outside the
European Union (EU), was filed for marketing authorization through a centralized
procedure, supported by clinical data in more than 3,400 people. Based on
current evidence, the CHMP concluded that the benefit-risk balance of IMVANEX is
favorable and recommended that it be used in accordance with official national
recommendations for vaccination.
The CHMP's opinion on IMVANEX will now be referred to the European Commission
for final marketing authorization. The European Commission generally delivers
its final decision within three months of the CHMP recommendation. The decision
will be applicable to all 27 EU member states and European Economic Area
countries Iceland, Liechtenstein and Norway.
"We are pleased to receive a positive opinion from the European authorities and
we look forward to the decision by the European Commission. This represents a
significant milestone and scientific breakthrough for our company and our MVA-BN
vaccine technology platform, which we have taken from early research through
clinical development and the anticipated regulatory approval in just a decade,"
said Anders Hedegaard, President and CEO of Bavarian Nordic. "Final marketing
authorization, once received, will enable us to make IMVANEX commercially
available in the EU. We will continue our work 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
Chairman of the Board
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Paul Chaplin, EVP and Division President, Infectious Diseases. Phone
+49 1733 791737
About IMVANEX® Smallpox Vaccine
IMVANEX, known as IMVAMUNE outside the EU, is being developed as a safer
smallpox vaccine for immune compromised individuals, such as people with atopic
dermatitis (AD) and HIV. IMVANEX is the company's most advanced clinical program
based on MVA-BN® - a robust and adaptable vaccine platform suitable for
addressing a wide variety of infectious diseases and cancer.
IMVANEX has been developed since 2003 under contracts with the U.S. Government.
It is the first new vaccine developed under the U.S. government's "Project
BioShield" program to protect at risk populations from bioterrorism. Bavarian
Nordic has manufactured and supplied 16 million doses of the vaccine for
emergency use to the U.S. Strategic National Stockpile to-date. IMVANEX has also
been supplied to other government stockpiles around the world.
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline targets cancer
and infectious diseases, and includes ten development programs. In oncology, the
company's lead program is PROSTVAC®, a therapeutic vaccine candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial and is being developed under a collaboration agreement with the
National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has
been tested in nearly 600 patients. In infectious diseases, the company's lead
program is IMVAMUNE®/IMVANEX®, a non-replicating smallpox vaccine candidate that
is being developed and supplied for emergency use to the U.S. Strategic National
Stockpile under a contract with the U.S. Government. IMVAMUNE®/IMVANEX® is
currently in clinical Phase 3 development and marketing authorization
applications have been filed in EU and Canada.
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.
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.
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