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Bavarian Nordic Publishes its Annual Results 2008
Date:3/27/2009

contract. In 2009 we will have a continued strong focus on fulfilling this contract as well as a strong focus on preparing for the Phase III studies that we expect to initiate with both IMVAMUNE(R) and PROSTVAC(TM) in 2010."

Strong foundation for future growth and earnings

Despite the financial crisis and an economic slowdown, Bavarian Nordic recorded a positive development in 2008, and has laid a strong foundation for further value creation in 2009 and the years ahead. The expected positive development is based on the following elements:

    - Two vaccines moving into Phase III trials

    - Strong financial position

    - Profitable ongoing development and procurement contracts with a value
      of more than DKK 3.5 billion

    - Expectations to the US government's exercise of the contract option for
      additional development and procurement, worth more than DKK 6 billion

    - Ongoing contracts with countries outside USA

    - Partnership with the NCI, a world leading cancer research organisation

    - Strong patent portfolio

    - Pipeline with promising results

    - Future licensing agreement for PROSTVAC(TM)

    - The world's only manufacturing facility dedicated to the
      commercial-scale production of MVA based vaccines

    Important events after the balance sheet date
    IMVAMUNE(R) - end-of-Phase II meeting held with the FDA

After concluding the Phase II development of IMVAMUNE(R), Bavarian Nordic held an end-of-Phase-II meeting with the US health authorities (FDA) in the beginning of 2009 in order to discuss the Phase III study design. The meeting was a success and there was an open and highly constructive discussion with the FDA. Based on the meeting, Phase III studies are expected to be initiated in 2010.

The outcome of the meeting has no impact on the delivery of vaccines to the Strategic National Stockpile (SNS) under the RFP-
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SOURCE Bavarian Nordic A/S
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Related biology technology :

1. Bavarian Nordic Receives $50 Million Advance Payment from HHS for Fulfilling Contract Milestones
2. Bavarian Nordic Update - 2007 Annual Results, IMVAMUNE(R) Delivery Contract, Strategy Process
3. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
4. Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
5. Bavarian Nordics Case Against Oxford BioMedica
6. Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting
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