FDA Concludes that Bavarian Nordic has Fulfilled all Requirements to Support the Delivery of IMVAMUNE® to the US Government
(Thomson Reuters ONE) -
· 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.
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
Forward-looking statements
This announcement includes "forward-looking statements" that involve risks,
uncertainties and other factors, many of which are outside of our control that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent
events or circumstances after the date made, except as required by law.
About Bavarian Nordic
Bavarian Nordic A/S is a leading industrial biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline is focused in
the three areas; biodefence, cancer and infectious diseases, and includes seven
development programmes. Two programmes are under preparation for Phase III:
IMVAMUNE®, a third-generation smallpox vaccine is being developed under a
contract with the US government, and PROSTVAC(TM), a therapeutic vaccine for
advanced prostate cancer is being developed under a collaboration agreement with
the National Cancer Institute.
Bavarian Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit www.bavarian-nordic.com
[HUG#1395049]
2010-18-uk: http://hugin.info/100065/R/1395049/351899.pdf
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Datum: 17.03.2010 - 13:05 Uhr
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