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

VAMUNE(R) delivery.

Therefore the company expects delivery of IMVAMUNE(R) to the US government to be initiated during the period between fourth quarter of 2009 and before the end of second quarter 2010.

Negotiations with the US authorities for the further development of IMVAMUNE(R)

The US authorities have initiated negotiations with Bavarian Nordic for a new contract to develop a freeze-dried version of the IMVAMUNE(R) smallpox vaccine. This potential new project will have no influence on the ongoing RFP-3 contract for the procurement of 20 million doses of IMVAMUNE(R) and the licensure of the current liquid-frozen formulation, but represents an additional business opportunity.

Earlier this year BARDA published a Broad Agency Announcement (BAA) soliciting proposals for the advanced development of medical countermeasures against chemical, biological, radiological and nuclear (CBERN) threats. In June, Bavarian Nordic submitted a proposal for the development of a freeze-dried formulation of the MVA-based smallpox vaccine, IMVAMUNE(R). The proposal included the validation of the production process and the preclinical and clinical development to support the use of the new freeze-dried formulation of IMVAMUNE(R) following a declared emergency.

A freeze-dried formulation of IMVAMUNE(R) offers various new advantages in terms of increased shelf-life and improved stability of the vaccine compared to the current liquid-frozen formulation. Additionally, this will improve the cold-chain shipping logistics and storage. These are all important criteria for governments around the world that prioritise their bio terror preparedness.

The new technology for freeze-drying the vaccine will also be applicable for other MVA-BN(R) based vaccines.

PROSTVAC(TM) - therapeutic prostate cancer vaccine candidate

In February 2009 PROSTVAC(TM) data were presented at
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SOURCE Bavarian Nordic A/S
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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
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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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