BARDA exercises option on Bavarian Nordic's IMVAMUNE
BARDA's decision will fund the transfer of the validated manufacturing process of IMVAMUNE to a commercial manufacturing line with a larger capacity. Bavarian Nordic was awarded the contract in 2009, and subsequently validated that the freeze-dried formulation of its smallpox vaccine induced an equivalent immune response and efficacy as the current liquid frozen formulation in multiple animal models.
The freeze-dried formulation of IMVAMUNE is expected to reduce life cycle management costs based on a longer shelf life.
The execution of the option came after Bavarian Nordic enrolled 680 healthy subjects in a Phase II study meant to meet the clinical requirements for emergency use of freeze-dried IMVAMUNE in the U.S. If the study meets its endpoints, the product could be stockpiled in the U.S. Bavarian Nordic expects to send the results of the study to the U.S. Food and Drug Administration in 2015, which could support the production and supply of the vaccine in 2016.
Procurement for IMVAMUNE would need to be conducted through a new contract. Bavarian Nordic expects to initiate dialogue with the U.S. in 2014.