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Bavarian Nordic A/S - Half Year Interim Report 2009
Date:8/28/2009

KVISTGAARD, Denmark, August 28 /PRNewswire-FirstCall/ -- Today Bavarian Nordic published the company's half-year interim report 2009. The full financial statements are available on the company's website: http://www.bavarian-nordic.com. Below is an extract of the most significant matters in the report as well as events after the balance sheet date.

In the first half of 2009 Bavarian Nordic generated revenue of DKK 33 million and recorded a loss before tax of DKK 188 million. As of 30 June 2009 the Group's net free liquidity was DKK 489 million.

Bavarian Nordic's new prostate cancer vaccine - PROSTVAC(TM) has been further validated and shows blockbuster potential. Bavarian Nordic is progressing the development and Phase III preparations of PROSTVAC(TM):

    - End of phase II meeting with the FDA in Q4, 2009 and expected
      initiation of Phase III in 2010
    - Five ongoing clinical Phase I and II studies in different patient
      populations
    - Preparing the production for Phase III studies
    - Scientific publication of data
    - Ongoing discussions with prospective licensing partners

The U.S. Food and Drug Administration (FDA) has performed a GMP inspection of the IMVAMUNE(R) manufacturing facilities. These GMP inspections occurred at both Bavarian Nordic's Kvistgaard facility and at IDT in May 2009. The management of Bavarian Nordic consider these inspections to be successfully completed, and the corrective actions triggered by the inspections will be implemented within short time, causing no further investments. Bavarian Nordic has an ongoing and positive dialogue with FDA which confirms the expectations to start deliveries of IMVAMUNE(R) under the RFP-3 contract following the satisfactory implementation of the corrective actions. On this background the company expects delive
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SOURCE Bavarian Nordic A/S
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Related biology technology :

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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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8. Bavarian Nordic Announces its Interim Report for the Period 1 January to 31 March 2009
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10. Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R)
11. ThromboGenics - Business Update and Interim Results for the Seven Month Period Ending 30 June 2007
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