Bavarian Nordic Completes Smallpox Vaccine Phase 2 Trial in Vulnerable Population
Eczema patient data to be presented before American
Academy of Dermatology
KVISTGÅRD, Denmark - February 1, 2011 -
Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that it has
completed a clinical Phase 2 trial of its smallpox vaccine,
IMVAMUNE®, in individuals suffering from atopic dermatitis
(a.k.a. eczema). These individuals are at increased risk of
severe side effects from conventional replicating smallpox
vaccines. Safety and immunogenicity data from the trial will
be presented on February 5th at the Late Breaking Research
Symposium at the annual meeting of the American Academy of
Dermatology.
Despite its eradication, bioterrorism experts are concerned
about the possibility of an attack on the U.S. that exposes the
population to the smallpox virus. The government currently
stockpiles enough conventional smallpox vaccine to protect the
entire American public in the event of a smallpox bioterrorism
attack. However, these replicating smallpox vaccines are not
recommended and can cause severe complications for people with
compromised immune systems or atopic dermatitis. These rare
but potentially life threatening complications include progressive
vaccinia, generalized vaccinia, myo-/pericarditis and eczema
vaccinatum.
In the Phase 2 trial, 350 individuals with mild to moderate
atopic dermatitis were vaccinated with IMVAMUNE®, a
non-replicating smallpox vaccine. Adverse reactions and immune
responses were compared to 282 healthy subjects. Vaccination with
IMVAMUNE® was well tolerated in both study populations, and
subjects with atopic dermatitis generated strong vaccinia specific
immune responses similar to healthy subjects.
Meeting the U.S. Government's Need
The Department of Health and Human Services (HHS) highlighted
the need to protect vulnerable populations who are at increased
risk of severe side effects. In a 2010 Broad Agency
Announcement for medical countermeasure development, HHS specified
a requirement for enough attenuated smallpox vaccine "to protect 66
M [million] people, comprising those for whom smallpox vaccine is
contraindicated and their household contacts" including 10 million
immunocompromised and 28 million atopic dermatitis patients
(Solicitation No. BARDA-CBRN-BAA-10-100-SOL-00012).
The government is meeting only a portion of this requirement by
stockpiling 20 million doses of IMVAMUNE® for people with
immune deficiencies, in particular HIV. In 2010, Bavarian
Nordic delivered more than 2 million doses of the vaccine.
However, current government policy does not allow these doses to be
used for individuals with atopic dermatitis.
"The data from this trial strongly suggest that IMVAMUNE® is
suitable for individuals with atopic dermatitis," said Bavarian
Nordic President and CEO Anders Hedegaard. "With these
results, the government can and should take the next step of
expanding the population it protects with this vaccine."
Bavarian Nordic: An Established Biodefense
Leader
Founded in 1994, Bavarian Nordic is a leading industrial
biotechnology company working to target unmet medical needs by
developing and producing vaccines for the prevention and treatment
of life-threatening diseases. With more than a decade of
experience manufacturing smallpox vaccines and working with the
U.S. Government, Bavarian Nordic is a fully integrated
biopharmaceutical company with proven manufacturing and regulatory
expertise.
This study was funded in whole or in part with Federal funds
from the National Institutes of Health, National Institute of
Allergy and Infectious Diseases (Contract No.
DMID-N01-AI-40072).
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64
