Bavarian Nordic Will File for Market Approval for IMVAMUNE(R) in CanadaBy Bavarian Nordic As, PRNE
Sunday, November 29, 2009
KVISTGÅRD, Denmark, November 30 - 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
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
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.
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 www.bavarian-nordic.com
Contact: Anders Hedegaard, President & CEO, Bavarian Nordic, +45-23-20-30-64
Tags: Bavarian Nordic A/S, canada, denmark, Kvistgard