Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II
03 Marzo 2009 - 7:00AM
PR Newswire (US)
KVISTGAARD, Denmark, March 3 /PRNewswire-FirstCall/ -- Following
the completion of the Phase II clinical development of IMVAMUNE(R),
a third-generation smallpox vaccine, Bavarian Nordic has held an
end of Phase II meeting with the FDA to discuss the Phase III
development. The meeting was a success and there was an open and
highly constructive discussion with the FDA. This meeting
represented the first ever formal discussions with the agency to
license a vaccine under the new legislation of the animal rule - a
new regulatory path which allows the efficacy of products for
indications like smallpox to be established in suitable animal
efficacy models. This marks a major regulatory milestone in the
successful development of IMVAMUNE(R). The animal efficacy models
and phase III protocol have essentially been agreed with the agency
- outlining a clear path for licensure of IMVAMUNE(R). Once all
protocols have been agreed with the FDA a Vaccines Related
Biological Product Advisory Committee (VRBPAC) will be scheduled to
ratify the license strategy. This exceptional review path will
likely push the initiation of the Phase III studies into late 2010,
leading to the submission of a BLA in 2013. The outcome of the
meeting has no impact on the delivery of vaccines to the Strategic
National Stockpile (SNS) under the RFP-3 contract with the US
government, which is still expected to be initiated in 2009. In
clinical trials to-date, IMVAMUNE(R) has shown to be safe and well
tolerated in more than 2,400 people including more than 900 immune
compromised people, either infected with HIV or diagnosed with
atopic dermatitis. These clinical studies have demonstrated that
IMVAMUNE(R) induces a fast and strong immune response, which is
comparable to that induced by traditional smallpox vaccines.
However, the efficacy of IMVAMUNE(R) cannot be established in the
clinic, because smallpox no longer exist in the general population
and will have to rely on the animal rule. To this end Bavarian
Nordic has developed a number of efficacy models and has
demonstrated IMVAMUNE(R) induces a comparable, if not superior,
efficacy to that of traditional smallpox vaccines. Anders
Hedegaard, President & CEO of Bavarian Nordic, said: "We are
delighted with the outcome of the meeting with the FDA, as our
plans to license IMVAMUNE(R) were essentially agreed with the FDA.
Although the final protocols still have to be formally agreed with
the agency there is now a clear path to registering IMVAMUNE(R)."
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 business
strategy is focused in three areas: biodefence, cancer and
infectious diseases. Bavarian Nordic's proprietary and patented
technology MVA-BN(R) is one of the world's safest, multivalent
vaccine vectors. Bavarian Nordic has ongoing contracts with the US
government for the late-stage development and procurement of the
company's third-generation smallpox vaccine, IMVAMUNE(R). Bavarian
Nordic is listed on NASDAQ OMX Copenhagen under the symbol BAVA.
For more information please visit http://www.bavarian-nordic.com/
DATASOURCE: Bavarian Nordic A/S CONTACT: Contact: Anders Hedegaard,
President & CEO, Bavarian Nordic, +45-23-20-30-64
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