FDA Concludes that Bavarian Nordic has Fulfilled all Requirements to Support the Delivery of IMVAMUNE® to the US Government
- Delivery of 20 million doses of IMVAMUNE® expected to be initiated during first half of 2010
Kvistgård, Denmark, March 17, 2010 - Bavarian Nordic A/S (OMX: BAVA) announced today that it has received notification that the U.S. Food and Drug Administration (FDA) has accepted all the actions taken by the company to address the observations made during the inspection of the manufacturing facilities in 2009. This was the last step along with the clinical and preclinical data that will be used to potentially support the use of IMVAMUNE® following a declared emergency. Subsequently, the company will scale-up the production as planned, in order to increase the production volume, so the 20 million doses will be produced and delivered according to the contract. The first deliveries are expected to take place during first half of 2010 as previously communicated and the company consequently maintains its expectations for the financial results for 2010.
Anders Hedegaard, President & CEO comments: "This conclusion from the FDA concerning our manufacturing process as well as the data submitted in support of IMVAMUNE® to date, marks a major milestone for Bavarian Nordic, as we now completes the transformation into a fully industrial biotech company. With a full order sheet for the coming years, we are well positioned for future growth and success."
The company will host a conference call tomorrow, Thursday, March 18 at 3 p.m. CET. Details for the conference call will be available on the company's website during the day.