Quantcast
Last updated on April 19, 2014 at 5:20 EDT

U.S. Government Expands Population Eligible to Receive Bavarian Nordic’s Smallpox Vaccine in an Emergency

July 11, 2012

KVISTGAARD, Denmark, July 11, 2012 /PRNewswire/ –

– People with atopic dermatitis and HIV Now Eligible to Receive IMVAMUNE(R) in an
Emergency

Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. government has expanded
the population that is eligible to receive its attenuated smallpox vaccine, IMVAMUNE(R),
during an emergency. In the event of a public health emergency involving smallpox, the
government may now authorize the use of IMVAMUNE(R) to protect individuals of all ages
with HIV infection or atopic dermatitis (AD). Children, pregnant women, and nursing
mothers with HIV or AD are eligible to receive IMVAMUNE(R), despite limited clinical data
in these specific populations. Previously, only certain people with HIV were eligible.

The U.S. government currently stockpiles enough traditional smallpox vaccine to
protect the entire American public in the event of a smallpox bioterrorism attack.
However, these replicating smallpox vaccines may cause severe complications for people
with compromised immune systems or AD. IMVAMUNE(R) is being developed as an alternative
for these individuals.

“Bavarian Nordic is pleased that our continuing development of IMVAMUNE(R) supports
the United States’ goal of developing medical countermeasures for at-risk populations like
children with atopic dermatitis,” said Bavarian Nordic President and CEO Anders Hedegaard.
“We are committed to ensuring the most vulnerable populations have access to medical
countermeasures suited for their age and condition.”

“The National Eczema Association applauds the U.S. government’s efforts to develop and
stockpile a smallpox vaccine that can be safely used by the millions of Americans living
with atopic dermatitis,” said President and CEO of the National Eczema Association Julie
Block. “We are pleased that the government has prioritized the unique needs of the
individuals we represent and encourage the Department of Health and Human Services to
ensure that in the event of an emergency all atopic dermatitis sufferers have access to
this new vaccine.”

The Biomedical Advanced Research and Development Authority (BARDA) highlighted the
need to protect these vulnerable populations in its 2010 Broad Agency Announcement for
Medical Countermeasure Development, in which it noted the need for sufficient quantity of
attenuated smallpox vaccine to protect 28 million people with atopic dermatitis, 10
million people with compromised immune systems, and their household contacts, totalling 66
million people.

To date, the government has ordered 20 million doses of IMVAMUNE(R) to protect the 10
million people with immune deficiencies, in particular HIV. Bavarian Nordic expects to
complete delivery of these vaccine doses by 2013. Bavarian Nordic is also working with
BARDA to further improve IMVAMUNE(R) by developing a freeze-dried version of the vaccine,
which may have a longer shelf-life and simplified shipment and storage logistics.

“Bavarian Nordic will soon complete the manufacture of IMVAMUNE(R) for the Strategic
National Stockpile,” said Paul Chaplin, Infectious Disease Division President. “With this
significant increase of the eligible population we anticipate that this will lead to a
long term business relation with HHS to ensure IMVAMUNE(R) is available to protect all
Americans with atopic dermatitis and HIV from smallpox.”

Asger Aamund
Chairman of the Board

About atopic dermatitis

Atopic dermatitis is often referred to as atopic eczema or infantile eczema, which is
a specific type of eczema that is chronic, relapsing and frequently associated with other
type 1 allergic disorders such as asthma, food allergies and allergic rhinitis. People
with AD tend to have a mild immune defect in their skin that can allow certain viruses
such as vaccinia (the live virus used in conventional smallpox vaccines) to spread both
over the skin and internally, which may cause severe complications. These potentially life
threatening complications, include progressive vaccinia, generalized vaccinia,
myo-/pericarditis and eczema vaccinatum.

IMVAMUNE(R) smallpox vaccine and the immunocompromised population

Clinical trial data from over 3,400 people, including nearly 600 people with HIV and
nearly 400 people with AD in 15 ongoing or completed studies indicate that IMVAMUNE(R) has
a favourable safety profile and is well tolerated, including in individuals who should not
receive conventional smallpox vaccines. IMVAMUNE(R) is the first new vaccine developed
under the U.S. government’s “Project BioShield” that protects vulnerable populations like
those with HIV and AD from bioterrorism.

About Bavarian Nordic

Bavarian Nordic is a vaccine-focused 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 targets cancer and infectious diseases, and
includes ten development programs. In oncology, the company’s lead program is PROSTVAC(R),
a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an
ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with
the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC(R) has
been tested in nearly 600 patients. In infectious diseases, the company’s lead program is
IMVAMUNE(R), a third-generation smallpox vaccine candidate that is being developed and
supplied for emergency use to the U.S. Strategic National Stockpile under a contract with
the U.S. Government. For more information, visit http://www.bavarian-nordic.com

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.

Contact: Anders Hedegaard, President & CEO., Phone +45-23-20-30-64

SOURCE Bavarian Nordic A/S


Source: PR Newswire