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Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
Date:8/19/2008

.S. health authorities for evaluation of whether the data can support the use of IMVAMUNE(R) in a declared emergency. The completed submission will trigger a milestone payment of USD 25 million under the RFP-3 contract, which is expected in the fourth quarter of 2008.

An end of Phase II meeting request is expected to be submitted to the FDA in the second half of 2008 in order to discuss the Phase III study design and data requirements for a biologic licence application (BLA) with the FDA. Subsequently, the clinical activities to support Phase III studies are still expected to start in 2009.

The first deliveries of vaccines are expected in 2009. With a view to optimising the use of resources at the manufacturing facility at Kvistgard, Denmark, delivery of vaccines is expected to be distributed over the period 2009-2011. At the manufacturing facility, routine production has now been demonstrated over a period of a full year and Bavarian Nordic is currently in the first phase of increasing output.

Update on commercial activities

In first half of 2008, Bavarian Nordic signed contract with an Asian country for the delivery of a small order of IMVAMUNE(R). This initial order was the first since the award of the US contract for 20 million doses of IMVAMUNE(R) in 2007. The extent and value of the contract are undisclosed. Bavarian Nordic will manufacture and deliver IMVAMUNE(R) smallpox vaccines for this country before initiating the delivery of the 20 million doses of IMVAMUNE(R) for the U.S. government.

The commercial activities in Asia as well as in Europe and the Middle East have been expanded during the past six months and both Bavarian Nordic staff, as well as local agents experienced in government contracting are operating in teams in these three areas. Furthermore, Bavarian Nordic has engaged highly experienced people with knowledge within bio-terror and bio-preparedness to support the teams, enabling them to enter a professional a
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SOURCE Bavarian Nordic A/S
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