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Bavarian Nordic A/S - Half Year Interim Report 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: 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
    - 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

SOURCE Bavarian Nordic A/S
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