Bavarian Nordic said today it will furnish a bulk supply of its Imvamune® nonreplicating smallpox vaccine, valued at $100 million, to the U.S. Biomedical Advanced Research and Development Authority (BARDA).
The company said it will manufacture and store a bulk supply of Imvamune that can be converted into freeze-dried Imvamune at a later date, once the freeze-drying manufacturing process has been transferred to a commercial line and is approved by BARDA.
Bavarian Nordic reasons that a freeze-dried Imvamune would reduce life cycle management costs based on a longer shelf life and thus could replace the liquid–frozen version now stockpiled in the U.S. Strategic National Stockpile.
The freeze-dried version of the vaccine can fulfill the U.S. government’s long-term requirements for sufficient nonreplicating smallpox vaccine to protect 66 million Americans, consisting of individuals for whom a replicating smallpox vaccine is not recommended and their household contacts, according to the company.
Bavarian Nordic said it will produce the new order, and recognize revenue from it, in 2017.
The new order brings to $233 million the value of Imvamune supplied to BARDA by Bavarian Nordic. Last year, the company received a $133 million order for bulk Imvamune—although a contract for the eventual delivery of finished product to the U.S. government is still required before a dose price of the freeze-dried formulation is determined.
“This additional order of Imvamune will ensure that the preparedness of the U.S. government and the protection of its people will not wane,” Paul Chaplin, Bavarian Nordic’s president and CEO, said in a statement.
Imvamune, the company’s most advanced commercial program, is being developed as a smallpox vaccine for individuals unable to use traditional replicating vaccines, such as people with atopic dermatitis (AD) and human immunodeficiency virus (HIV) infection.
Imvamune has shown a favorable safety profile in clinical studies with more than 7600 subjects, including people diagnosed with AD or infected with HIV.
In 2013, the vaccine was approved in Canada, as well as in the European Union, where it is marketed as Imvanex®.