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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 Copyright©2008 PR Newswire. All rights reserved |