Regulatory Filings • Oct 12, 2010
Regulatory Filings
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US Government Exercises Next Part of Bavarian Nordic's Freeze-Dried IMVAMUNE® Contract
US Government Exercises Next Part of Bavarian Nordic's Freeze-Dried IMVAMUNE® Contract
Kvistgård, Denmark, October 12, 2010 - Bavarian Nordic A/S (OMX: BAVA) announced today that BARDA (Biomedical Advanced Research and Development Authority) has exercised the next option under the contract for the development of a freeze-dried version of Bavarian Nordic's IMVAMUNE® smallpox vaccine.
The option, which was triggered by the successful completion of certain development milestones, provides next year's funding under the contract, totalling approx. USD 14 million. The total prospective value of the five-year contract, awarded in 2009, is 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®. The freeze-dried development activities are performed in parallel to the licensure activities of the current liquid-frozen IMVAMUNE® formulation under the RFP-3 contract.
The above does not affect the company's expectations for the 2010 full year results.
Bavarian Nordic's President & CEO, Anders Hedegaard commented: "We are pleased with the US Government's continued support to advance the development of IMVAMUNE® as a safer smallpox vaccine. Besides our ongoing contract for the development and delivery of 20 million doses of IMVAMUNE® with an option of additional 60 million doses in the current liquid-frozen formulation to the US Strategic National Stockpile, we are committed to the development of a freeze-dried version of IMVAMUNE®, which offers a number of new advantages, thus representing an additional business opportunity which we intend to explore."
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About Bavarian Nordic
Bavarian Nordic 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 clinical pipeline targets cancer and infectious diseases, and includes seven development programmes. Two programmes under preparation for Phase III: PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is being developed under a collaboration agreement with the National Cancer Institute, and IMVAMUNE®, a third-generation smallpox vaccine is being developed under a contract with the US government.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please 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.
HUG#1451012
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