Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R)
24 Août 2009 - 2:00PM
PR Newswire (US)
KVISTGAARD, Denmark, August 24 /PRNewswire-FirstCall/ -- Bavarian
Nordic A/S (OMX: BAVA) announced today that the US authorities have
initiated negotiations for a new contract to develop a freeze-dried
version of the IMVAMUNE(R) smallpox vaccine. This potential new
project will have no influence on the ongoing RFP-3 BARDA
(Biomedical Advanced Research and Development Authority) contract
for the procurement of 20 million doses of IMVAMUNE(R) and the
licensure of the current liquid-frozen formulation, but represents
an additional business opportunity. Earlier this year BARDA
published a Broad Agency Announcement (BAA) soliciting proposals
for the advanced development of medical countermeasures against
chemical, biological, radiological and nuclear (CBERN) threats. In
June, Bavarian Nordic submitted a proposal for the development of a
freeze-dried formulation of the MVA-based smallpox vaccine,
IMVAMUNE(R). The proposal included the validation of the production
process and the preclinical and clinical development to support the
use of the new freeze-dried formulation of IMVAMUNE(R) following a
declared emergency. A freeze-dried formulation of IMVAMUNE(R)
offers various new advantages in terms of increased shelf-life and
improved stability of the vaccine compared to the current
liquid-frozen formulation. Additionally, this will improve the
cold-chain shipping logistics and storage. These are all important
criteria for governments around the world that prioritise their bio
terror preparedness. The new technology for freeze-drying the
vaccine will also be applicable for other MVA-BN(R) based vaccines.
Anders Hedegaard, President & CEO of Bavarian Nordic said: "We
are happy about entering into negotiations with the US government
on yet another RFP for IMVAMUNE(R). It clearly demonstrates their
desire to expand the ongoing collaboration beyond the existing
contract to deliver 20 million doses of IMVAMUNE(R) and we look
forward to exploring this exciting opportunity." 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. About
Bavarian Nordic Bavarian Nordic A/S is a leading industrial
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 is focused in the
three areas; biodefence, cancer and infectious diseases, and
includes seven development programmes. Two programmes are ready for
Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is
being developed under a contract with the US government, and
PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is
being developed under a collaboration agreement with the National
Cancer Institute. Bavarian Nordic is listed on NASDAQ OMX
Copenhagen under the symbol BAVA. For more information please visit
http://www.bavarian-nordic.com/ DATASOURCE: Bavarian Nordic A/S
CONTACT: Contact (media only): Anders Hedegaard, President &
CEO, Bavarian Nordic, +45-23-20-30-64
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