Bavarian Nordic's published timelines for initiating delivery in 2009 was based on an assumption of the timely review and acceptance of Bavarian Nordic's last summary data submission made in November 2008. This data submission triggered a USD 25 million milestone payment and represented the successful completion of a major milestone of the RFP-3 contract. The completion of the milestone from BARDA followed by an FDA review of the data was expected to be the last hurdle before deliveries under the RFP-3 contract could start. However, by the spring this year, the FDA responded to this submission with the notice that, as a final step before deliveries, they would perform a Good Manufacturing Practice (GMP) inspection of the IMVAMUNE(R) manufacturing facilities. These GMP inspections were carried out at both Bavarian Nordic's Kvistgaard facility and IDT (the company's contract filling partner, already GMP approved by the European authorities) in May 2009.
While the FDA did not raise any concerns regarding the facilities or the IMVAMUNE(R) validated manufacturing process, a number of observations were noted, requiring corrective actions. This is usual following an inspection by regulatory authorities. The company has already initiated its responses to these observations but the corrective actions and FDA review and acceptance will take additional months. Implementation of the corrective actions will cause no further investments.
While this represents a delay in the planned delivery of IMVAMUNE(R),
following review of the data, the FDA have not raised any concerns regarding
the animal, clinical or manufacturing data that has been submitted to support
the use of IMVAMUNE(R) in a declared emergency. Thus satisfactory
implementation of the corrective actions following the FDA inspection should
trigger the start of IM
|SOURCE Bavarian Nordic A/S|
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