Bavarian Nordic A/S announced this week that the Biomedical Advanced Research and Development Authority (BARDA) has exercised an option at a value of USD 21.9 million under the existing development contract for freeze-dried IMVAMUNE smallpox vaccine.
This award will fund the transfer of the already validated manufacturing process to a commercial manufacturing line with a larger capacity.
Under the freeze-dried contract, which was awarded in 2009, the Bavarian Nordic has validated the freeze-dried manufacturing process and shown the freeze-dried formulation to induce an equivalent immune response and efficacy as the current liquid frozen formulation in numerous animal models.
The execution of this option follows the completion of enrollment of 680 healthy subjects in a Phase 2 study designed to meet the clinical requirements for emergency use in the U.S. of the freeze-dried formulation of the vaccine, which would enable the product to be stockpiled. A freeze-dried formulation is expected to reduce life cycle management costs based on a longer shelf life.
Data from the study are expected to be submitted to the FDA in 2015, potentially supporting the production and supply of freeze-dried IMVAMUNE in 2016. Procurement would need to be conducted through a new contract, which the Company expects to initiate dialogue with the U.S. Government in 2014.
