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Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2009
Date:11/11/2009

Bavarian Nordic expects that an end of phase II meeting with the FDA will take place during January 2010. While partnership negotiations are ongoing, the company is in preparations for Phase III and these are proceeding as planned.

Lately, the prostate cancer field has witnessed positive clinical results followed by attractive partnership deals. It has proven worthwhile for a number of companies to independently advance their projects into Phase III, thus maximising their value before they would eventually sign a licensing deal. Similarly, Bavarian Nordic is seeking to maximise and retain the value of its cancer portfolio. Consequently, Bavarian Nordic seeks the ability to advance PROSTVAC(TM) into Phase III of its own. In order for Bavarian Nordic to gain the independence to execute its short and long term activities within biodefence and cancer, the company is exploring available options for securing an optimum financial position.

Highlights from the period

Bavarian Nordic has signed contract with an EU country for the delivery of IMVAMUNE(R)

In September, Bavarian Nordic signed a contract with the military of an undisclosed EU country for the delivery of a small order for IMVAMUNE(R). The size and value of the contract is undisclosed. This marks the first time, Bavarian Nordic enters a contract with an EU country for the delivery of IMVAMUNE(R), and it demonstrates that there exists a real demand inside of EU for new and safer smallpox vaccines for preparedness stockpiles. The vaccines have been delivered.

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

Bavarian Nordic is currently in late-stage negotiations with the US authorities 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
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Related biology technology :

1. Bavarian Nordic Has Signed Contract With an EU Country for the Delivery of IMVAMUNE(R)
2. Bavarian Nordic A/S - Half Year Interim Report 2009
3. Bavarian Nordic in Negotiations With the US Authorities for the Further Development of IMVAMUNE(R)
4. The Court Supports Bavarian Nordics Decision to Start Patent Infringement Case Against Oxford BioMedica
5. Bavarian Nordic Announces its Interim Report for the Period 1 January to 31 March 2009
6. Bavarian Nordic Publishes its Annual Results 2008
7. Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting
8. Bavarian Nordics Case Against Oxford BioMedica
9. Bavarian Nordic Receives USD 25 Million Milestone Payment After Submission of Important IMVAMUNE(R) Data to The U.S. Health Authorities
10. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
11. Bavarian Nordic Update - 2007 Annual Results, IMVAMUNE(R) Delivery Contract, Strategy Process
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