Emergent plans to triple anthrax vaccine production
pharmafile | January 21, 2014 | News story | Manufacturing and Production |Â Â Emergent BioSolutions, FDA, anthrax, biothraxÂ
Emergent BioSolutions is planning a major expansion of manufacturing capacity for its anthrax vaccine BioThrax to meet the biodefense objectives of the US government.
BioThrax is currently the only Food and Drug Administration licensed vaccine to prevent anthrax disease in the US, and Emergent has a five-year contract to provide supplies for the Centre for Disease Control and Prevention (CDC) biodefense stockpile.
While the near-term objective of providing 44.75 million doses by the third-quarter of 2016 is on track, Emergent’s chief executive Daniel Abdun-Nabi told the JPMorgan healthcare conference that the company is working with the government on another facility to boost production.
“We are currently capacity constrained at seven million to nine million doses per year,” said Abdun-Nabi, who said the objective is to reach capacity of 20 million to 25 million units a year.
“The CDC has identified a target or specified a target of 75 million doses of an anthrax vaccine in the stockpile [but] our estimate is they are not even at 30 million yet,” he added, noting that – with a four-year shelf-life – current production levels for BioThrax will not allow the government to meet its target.
The expansion plans are focussed on Building 55, Emergent’s large-scale vaccine manufacturing facility in Lansing, Michigan, and Abdun-Nabi said the project is a ‘key driver’ for the company as a whole.
The 20 to 25 million capacity will be reached with a single production train at the facility, and adding a second train would take up to two years but would allow capacity to be doubled once again. The increased production could also be used to supply orders for BioThrax from elsewhere in the world.
Last year, Emergent secured its first approval for BioThrax in Germany, its first EU market. Emergent also added to its manufacturing capabilities recently with its $22 million acquisition in December of Canadian firm Cangene.
The acquisition will give Emergent fill-and-finish capabilities for the first time – as well as an immediate entry into the contract manufacturing business based at facilities in Winnipeg and Baltimore.
Cangene also has a CDC contract for the supply of an anthrax treatment based on intravenous immune globulin, as well as a number of other marketed products including WinRho for immune thrombocytopenic purpura and blood type mismatch between pregnant mothers and their foetuses.
The Cangene takeover is due to complete later this quarter, said Emergent, and should help boost revenues from around $311 million in 2013 to $415 to $445 million this year.
Phil Taylor
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