US Government Awards Contract to Bavarian Nordic for the Development of Freeze-Dried IMVAMUNE(R) Smallpox Vaccine
17 Noviembre 2009 - 7:00AM
PR Newswire (US)
KVISTGARD, Denmark, November 17 /PRNewswire-FirstCall/ -- Bavarian
Nordic A/S (OMX: BAVA) announced today that BARDA (Biomedical
Advanced Research and Development Authority) has awarded a new
contract to Bavarian Nordic for the development of a freeze-dried
version of its IMVAMUNE(R) smallpox vaccine with a total
prospective value of USD 40 million. The contract provides funds to
validate the new freeze-dried manufacturing process and the
associated pre-clinical and clinical studies to support the
advanced development of a freeze-dried version of IMVAMUNE(R). The
base year funding represents 33% of the total contract value,
followed by four additional years of optional funding, which are
triggered by the completion of pre-determined technical milestones.
These freeze-dried development activities will be performed in
parallel to the licensure activities of the current liquid-frozen
IMVAMUNE(R) formulation under the RFP-3 contract. The contract does
not affect the company's expectations for the 2009 full year
results. With this contract, the US Government has to-date awarded
contracts to Bavarian Nordic for the development and procurement of
IMVAMUNE(R) worth more than USD 680 million. Under the ongoing RFP
3 contract, Bavarian Nordic will deliver 20 million doses of
IMVAMUNE(R) in the current liquid-frozen formulation. Once the
contract option for an additional 60 million doses is expectedly
exercised, these vaccines will be delivered in the liquid-frozen
formulation as well. Thus, the new contract will have no influence
on the ongoing contracts, but represents an additional business
opportunity and will expectedly constitute the gateway towards
securing additional contracts for this new freeze-dried version
with the US Government and outside the US as well. A freeze-dried
formulation of IMVAMUNE(R) offers various new advantages in terms
of a potential increased shelf-life compared to the current
liquid-frozen formulation. Additionally, this would help overcome
the challenges with the cold-chain logistics and storage. Anders
Hedegaard, President & CEO of Bavarian Nordic said: "We are
excited about receiving yet another contract from the US Government
in support for the development of an advanced freeze-dried version
of our IMVAMUNE(R) smallpox vaccine. It clearly demonstrates the
continued commitment from the US Government to support the
development of advanced medical countermeasures and it strengthens
our confidence, that the option to procure up to an additional 60
million doses of IMVAMUNE(R) under the ongoing RFP-3 contract will
be exercised." 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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