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Bavarian Nordic

Regulatory Filings Apr 11, 2011

3354_iss_2011-04-11_ddc3363c-5cac-4ea6-8934-6bad251a39f0.html

Regulatory Filings

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Bavarian Nordic's Contract for Development of a Freeze-dried Version of IMVAMUNE® Smallpox Vaccine Extended to a Total Value of USD 94 million

Bavarian Nordic's Contract for Development of a Freeze-dried Version of IMVAMUNE® Smallpox Vaccine Extended to a Total Value of USD 94 million

***Not for release, publication or distribution in the United States, Canada, Australia or Japan

***This announcement does not constitute an offer to sell or the solicitation of an offer to buy the securities of Bavarian Nordic A/S (the "Securities") in the United States or in any other jurisdiction. The Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. The issuer of the Securities has not registered, and does not intend to register, any portion of the Offering in the United States or in any jurisdiction outside Denmark and the United Kingdom, and does not intend to conduct a public offering of the Securities in the United States or in any other jurisdiction outside Denmark and the United Kingdom. Copies of this announcement are not being made and may not be distributed or sent into the United States, Canada, Australia or Japan. 

This announcement is only being distributed to, and is only directed at, persons in the United Kingdom that are qualified investors, as that term is defined in the Prospectus Directive, that are also (i) "investment professionals" falling within Article 19(5) of the Financial Service and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) "high net worth entities"  and other persons to whom it may lawfully be communicated, falling within the meaning of Article 49(2)(a) to (d) of the Order (all such persons being "relevant persons"). The securities of Bavarian Nordic A/S (the "Securities") are only available to relevant persons and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its content. 

Kvistgård, Denmark, April 11, 2011

- Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA) has increased the value of the existing contract to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40 million to USD 94 million.   

The contract provides funds to validate the new freeze-dried manufacturing process and the associated pre-clinical and clinical studies to support the development of a freeze-dried version of IMVAMUNE®. The increased funding will support additional studies and manufacturing activities to further advance the development of the freeze-dried version of IMVAMUNE® by the end of the contract period. 

The freeze-dried contract was originally awarded in November 2009 and provided base year funding, followed by optional annual funding until 2014. The first option to fund the program during 2011 was already exercised by BARDA in 2010, providing a total of USD 27 million. As of March 1st, 2011 USD 5 million were recognized as revenue. While the additional funding will have no impact on revenues for 2011, revenues from the freeze-dried contract will increase in 2012 to 2014. 

This contract offers an additional business opportunity to Bavarian Nordic as a freeze-dried formulation of IMVAMUNE® offers various new advantages in terms of a potential increased shelf-life compared to the current liquid-frozen formulation and would also improve the cold chain logistics during shipment. The freeze-dried development activities are performed in parallel to the licensure and supply activities of the current liquid-frozen IMVAMUNE® formulation under the RFP-3 contract. 

To date, Bavarian Nordic has been awarded development and supply contracts for IMVAMUNE® from the US Government totalling more than USD 740 million. 

Anders Hedegaard, President & CEO of Bavarian Nordic said: "This contract further strengthens our long-term collaboration with the U.S. Government in the development of medical countermeasures. While the deliveries of the first 20 million doses of IMVAMUNE® in the current liquid-frozen formulation to the US Strategic National Stockpile are currently ongoing, this contract allows us to focus on advancing our development to further improve IMVAMUNE® and we believe that this will form the basis for future new contracts with the U.S. Government."   

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®, 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 

PROSTVAC® is a registered trademark in the U.S. 

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.

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