Positive results from Phase III study of Imvamune vaccine for Smallpox-Bavarian Nordic

Bavarian Nordic has announced results from the first of two pivotal Phase III studies of the liquid-frozen formulation of Imvamune, supporting a Biologics License Application for US approval of the vaccine for Smallpox. In addition, the Company announced results from a pivotal Phase II 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 III study showed 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 II placebo controlled study that was recently published and clearly differentiates the safety profile of Imvamune when compared to traditional smallpox vaccines (e.g. ACAM2000) that have recorded high rates of cardiac complications in healthy vaccinees (5.73 events per thousand immunizations).

The Phase II study compared the safety and immunogenicity of a freeze-dried and a liquid-frozen formulation of Imvamune and enrolled 650 vaccinia-na�ve 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.

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.