Bavarian Nordic Announces Positive Results from Two Pivotal Clinical Studies of IMVAMUNE® Smallpox Vaccine
(Thomson Reuters ONE) -
* Completion of first Phase 3 study to support a Biologics License Application
for liquid-frozen IMVAMUNE
* Completion of clinical development to support stockpiling of the next-
generation freeze-dried version of IMVAMUNE
KVISTGAARD, Denmark, May 13, 2015 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
today announced results from the first of two pivotal Phase 3 studies of the
liquid-frozen formulation of IMVAMUNE(®) supporting a Biologics License
Application for U.S. approval of the vaccine. In addition, the Company announced
results from a pivotal Phase 2 study of freeze-dried IMVAMUNE smallpox vaccine
supporting the clinical requirements for an Emergency Use Authorization, which
would allow for stockpiling of this next-generation of the vaccine.
The Phase 3 was designed as a randomized, double-blind, placebo-controlled study
in 4,000 vaccinia-naïve subjects. Three thousand (3,000) subjects were
vaccinated with three different manufacturing lots of the liquid-frozen IMVAMUNE
formulation (1,000 subjects per lot) and compared to 1,000 subjects that
received placebo. The three lots of IMVAMUNE induced equivalent antibody
responses, meeting the primary endpoint of the study, while the favorable safety
profile of IMVAMUNE was confirmed in this largest clinical study performed to
date. Despite close cardiac monitoring of all subjects, no serious adverse
reactions were reported among the 3,000 subjects vaccinated with IMVAMUNE,
confirming the results of a smaller Phase 2 placebo controlled study that was
recently published(i )and clearly differentiates the safety profile of IMVAMUNE
when compared to traditional smallpox vaccines (e.g. ACAM2000(®) approved in the
U.S.) that have recorded high rates of cardiac complications in healthy
vaccinees (5.73 events per thousand immunizations(ii)).
The Phase 2 study compared the safety and immunogenicity of a freeze-dried and a
liquid-frozen formulation of IMVAMUNE and enrolled 650 vaccinia-naïve healthy
subjects who were randomized to receive either formulation of IMVAMUNE. The
freeze-dried vaccine induced an equivalent antibody response as the liquid-
frozen version, meeting the primary endpoint of the study. Also both
formulations recorded a similar safety profile, confirming that the clinical
data generated cumulatively in more than 7,600 vaccinated subjects is relevant
for both formulations of IMVAMUNE.
The results provide the final clinical data required to support stockpiling of
the freeze-dried version of IMVAMUNE in the U.S. Strategic National Stockpile.
Supported by a contract option of USD 22 million exercised by the Biomedical
Advanced Research and Development Authority (BARDA) in 2014, Bavarian Nordic is
currently working to transfer the freeze-drying process to a new manufacturing
line with a larger commercial capacity. These manufacturing activities remain
on-track to be finalized this year, which is the final step towards meeting the
regulatory requirements to stockpile the freeze-dried version of IMVAMUNE.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said:
"Completing this pivotal Phase 2 study is a significant step in the transition
to the freeze-dried version of the vaccine, which provides a number of
advantages for the future procurement and stockpiling, thereby broadening the
commercial potential. We remain on track to complete the transfer of the
manufacturing process which will enable us to start deliveries in 2016, as we
look forward to continuing our successful long-standing collaboration with the
U.S. Government on their public health preparedness."
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Federal funding acknowledgments
The Phase 2 study comparing the safety and immunogenicity of a freeze-dried and
a liquid-frozen formulation of IMVAMUNE has been funded in whole or in part with
Federal funds from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority, under Contract
No. HHSO100201000011C.
The Phase 3 study evaluating the immunogenicity and safety of three consecutive
production lots of IMVAMUNE has been funded in whole or in part with Federal
funds from the Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, under Contract No.
HHSO100200700034C
About Bavarian Nordic
Bavarian Nordic is a biopharmaceutical company focused on the development and
manufacturing of cancer immunotherapies and vaccines for infectious diseases.
Through a long-standing collaboration with the U.S. Government, Bavarian Nordic
has developed a portfolio of biological countermeasures, including the non-
replicating smallpox vaccine, IMVAMUNE(®), which is stockpiled for emergency use
by the U.S. and other governments. The vaccine is approved in the EU (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are pioneering the development of an Ebola vaccine, which has been fast-tracked
by authorities in response to the current situation in West Africa.
Additionally, in collaboration with the National Cancer Institute, Bavarian
Nordic has developed a portfolio of active cancer immunotherapies based on its
versatile pox-virus based technologies, including PROSTVAC(®), which is
currently in Phase 3 clinical development for the treatment of advanced prostate
cancer. The company has partnered with Bristol-Myers Squibb for the potential
commercialization of PROSTVAC. For more information visit www.bavarian-
nordic.com or follow us on Twitter (at)bavariannordic.
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.
--------------------------------------------------------------------------------
(i) PLoS ONE: Zitzmann-Roth E-M, von Sonnenburg F, de la Motte S, Arndtz-
Wiedemann N, von Krempelhuber A, Uebler N, et al. (2015) Cardiac Safety of
Modified Vaccinia Ankara for Vaccination against Smallpox in a Young, Healthy
Study Population. PLoS ONE 10(4): e0122653. doi:10.1371/journal.pone.0122653
(ii )ACAM2000 Vaccines and Related Biological Products Advisory Committee
(VRBPAC) Briefing Document, April 2007
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4292B2-00-index.htm
201514uk:
http://hugin.info/100065/R/1921250/688491.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
[HUG#1921250]
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Datum: 13.05.2015 - 07:31 Uhr
Sprache: Deutsch
News-ID 392835
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