Bavarian Nordic Completes Smallpox Vaccine Phase 2 Trial in Vulnerable Population

Eczema Patient Data to be Presented Before American Academy of Dermatology

KVISTGARD, 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(R), 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(R), a non-replicating smallpox vaccine. Adverse reactions and immune responses were compared to 282 healthy subjects. Vaccination with IMVAMUNE(R) 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(R) 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(R) 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.

SOURCE: Bavarian Nordic

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