Smallpox Vaccine IMVAMUE Found Successful in Phase 3 Clinical Study

A biotechnology company announced positive results from a Phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE®.

This is the second positive Phase 3 study demonstrating the safety and efficacy of IMVAMUNE.

This clinical study demonstrated non-inferiority, which means not worse than ACAM2000, the current U.S. licensed replicating smallpox vaccine.

Additionally, IMVAMUNE recorded a statistically superior immune response (2x) and the majority of volunteers achieved primary vaccination, requiring no need for re-vaccination.

IMVAMUNE is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis (AD) and HIV.

IMVAMUNE, delivered via an intramuscular injection, is based on a strain of the Modified Vaccinia Ankara virus that is incapable of replicating in the body. It elicits an immune response without the post-vaccination complications associated with traditional smallpox vaccines that are administered via pricking the skin.

IMVAMUNE has been given to more than 7,800 subjects in 21 clinical studies, including two Phase 3 studies that have supported a favorable safety profile and efficacy in comparison to replicating smallpox vaccines.

"These and earlier study results validate the promise of IMVAMUNE for the prevention of smallpox and support product registration with the U.S.FDA," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

The IMVAMUNE Smallpox Vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX® as the only non-replicating smallpox vaccine approved for use in the general population.

The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 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.

Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile for emergency use. The Company has ongoing contracts the Biomedical Advanced Research and Development Authority (BARDA) to replenish the stockpile with a freeze-dried formulation of the vaccine, which offers improved shelf life.

Bavarian plans to file its U.S. marketing application under Fast Track status.

If approved, it will receive a Priority Review voucher for accelerated review of a future application or it can be sold to a third party.

For more information visit www.bavarian-nordic.com