Bavarian Nordic Will File for Market Approval for IMVAMUNE(R) in Canada
30 Noviembre 2009 - 7:00AM
PR Newswire (US)
KVISTGARD, Denmark, November 30 /PRNewswire-FirstCall/ -- Bavarian
Nordic A/S (OMX: BAVA) announced today that the company expects to
file a New Drug Submission (NDS) for its third-generation smallpox
vaccine, IMVAMUNE(R) with the Canadian Authorities, Health Canada
in 2010. If successful, this would be the first marketing approval
of IMVAMUNE(R). Following the completion of the Phase II
development for IMVAMUNE(R), Bavarian Nordic held a meeting with
Health Canada in October, 2009. Upon review of the current data
package, which included the manufacturing, clinical and animal
data, Health Canada recommended that Bavarian Nordic submit a NDS
application for consideration to license IMVAMUNE(R) as a smallpox
vaccine for the general population. The NDS is expected to be filed
in the second half of 2010, possibly leading to the first license
of IMVAMUNE(R) during 2011. In 2008, Bavarian Nordic was awarded a
contract by the Canadian Government for the acquisition of 20,000
doses of IMVAMUNE(R) which were recently delivered and accepted
under a Canadian Special Access Programme. Under the contract, the
Canadian Authorities will provide Bavarian Nordic with
milestone-based funding for the filing of the NDS for IMVAMUNE(R)
in Canada, and this forms part of Bavarian Nordic's global
licensure plans for IMVAMUNE(R). Anders Hedegaard, President &
CEO of Bavarian Nordic said: "We are well on the way to achieve a
significant milestone in the development of IMVAMUNE(R), as we are
about to get the first regulatory approval of the vaccine. This is
indeed recognition that IMVAMUNE(R) is superior to the current
approved smallpox vaccines that are stockpiled in many countries.
Our strategy to develop and obtain regulatory approval for
IMVAMUNE(R) as a vaccine for the general population, including
those who are contraindicated to the traditional vaccines, and
without causing the same serious adverse events, is now finally
about to succeed. Furthermore this is a recognition of our
technology since it will represent the first approval of an
MVA-BN(R) based product, leading to new opportunities for
commercialising our technology." IMVAMUNE(R) represents a safer
smallpox vaccine Currently, IMVAMUNE(R) has been shown to be safe
and well tolerated in more than 2,700 people in 12 ongoing or
completed clinical trials. This includes approximately 1,000 people
currently contraindicated for licensed smallpox vaccines, namely
HIV-infected or people diagnosed with Atopic Dermatitis.
IMVAMUNE(R) has shown to be highly immunogenic in both healthy
subjects and people with weakened immune systems and these immune
responses have been shown to be comparable to those induced by
traditional smallpox vaccines. IMVAMUNE(R) has also been shown to
induce a post-exposure protection in immune suppressed animals,
which succumbed to the vaccination with traditional smallpox
vaccines. Moreover, IMVAMUNE(R) was shown to induce a comparable
efficacy as ACAM2000(TM), the licensed second-generation smallpox
vaccine in the US, in non-human primates. 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 ready for
Phase III: IMVAMUNE(R), 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
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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