BioThrax is the only US approved anthrax vaccine and since 2008 Emergent has been supplying the Centers for Disease Control and Prevention (CDC) to support the US Government’s programme to stockpile the product in anticipation of the need for mass vaccinations owing to a future bio-terrorist anthrax attack.
The procurement contract with the CDC was scheduled to expire on September 30. However, during a Q1 results call last week, CEO Daniel Abdun-Nabi said the CDC had signalled its intent to ink a follow-on contract, “thereby ensuring an uninterrupted supply of BioThrax into the Strategic National Stockpile.”
He continued (transcript here): “Also in the April 26 letter, the CDC advised us that they anticipate continued procurement of BioThrax in the second and third quarters, although they had not specified the specific number of doses to be purchased.”
Emergent believes the CDC follow-on contract is due to the upcoming opening of the manufacturer’s Building 55, located in Lansing, Michigan.
The firm recently submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) supported by data demonstrating that a scale-up of BioThrax manufactured in Building 55 is comparable to BioThrax made at the firm’s current plant.
Abdun-Nabi said he anticipates a typical FDA review cycle of four months, which includes a preapproval inspection, and as such estimates the review process will be completed in the fall of this year.
“We believe [the CDC’s] thinking has been influenced by the earlier than expected submission of the sBLA for Building 55, the possible licensure of that facility earlier than previously forecast, and how we are coming to the end of the delivery schedule on our current contract.”
Capacity and overseas contracting?
When production commences at Building 55, the facility will potentially be able to supply 20 to 25 million doses annually - up from current capacity of seven to nine million doses – expediting the CDC’s desire of stockpiling 75 million doses.
And with greater capacity, the firm was asked whether it would be looking to offer BioThrax to other customers internationally.
“We really haven't been in the fortunate circumstance of having sufficient quantities to sell outside the US,” Abdun-Nabi told stakeholders.
“Building 55, when we bring it online, will help a bit, but those international markets are still developing and it's a little too early to reliably predict what that international revenue might look like.”
For the first quarter 2016, Emergent reported sales of $72m, up almost 300% on the same period last year due to the $59m contribution of BioThrax. In Q1 2015, BioThrax clocked in zero sales due to the suspension of shipments to the CDC following the discovery of foreign particles in a limited number of vials.