Emergent filed a supplemental Biologics License Application (sBLA) seeking permission to make BioThrax at the facility – known as Building 55 – in April. Earlier today the firm announced the request had been accepted for review, adding that it expects a decision in August.
Adam Havey, Emergent’s executive vice president and president, biodefense division, said the facility is “intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually.”
The capacity hike is required to comply with the US Government’s aim of building a stockpile of 75 million doses.
Approval effort
Emergent first mooted the idea of using Building 55 to make BioThrax in 2009 when it undertook a series of real estate deals designed to “free up” the plant for vaccine production.
Since then the firm has conducted a number of studies designed to prove that BioThrax made at Building 55 is comparable to that produced at its currently licensed facility, known as Building 12.
Emergent’s efforts to win US Food and Drug Administration (FDA) licensure for the facility and a of a large scale manufacturing Process for BioThrax has been supported by a $104m contract from the US Biomedical Advanced Research and Development Authority (BARDA).
BioThrax
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 efforts to develop a stockpile for use in the event of a terrorist attack.
According to Emergent's first quarter results supplying BioThrax to the CDC generated $59m of the firm's $72m revenue.
The supply contract is scheduled to expire on September 30. However, during a Q1 results call in May, CEO Daniel Abdun-Nabi predicted the CDC would rene, “thereby ensuring an uninterrupted supply of BioThrax into the Strategic National Stockpile.”
Tracey Schmitt Lintott SVP, Global Public Affairs told us "We received a letter from the CDC dated April 1 informing us of their intent to award a follow-on BioThrax procurement contract, thereby ensuring an uninterrupted supply of BioThrax into the Strategic National Stockpile.
"The CDC reaffirmed their intent in a follow-up letter dated April 26 in which they stated that their acquisition planning process is ongoing and that they project to issue an award for a follow-on contract on October 1. This is entirely consistent with our expectation for continued, uninterrupted supply of BioThrax."