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news.Emergent BioSolutions has entered into a $107m contract with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for manufacturing of BioThrax (anthrax vaccine adsorbed) in Emergent BioSolutions' vaccine manufacturing facility in Lansing, Michigan.
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Emergent BioSolutions said that the contract is a two-year base period of performance valued at $54.6m and three option years that, if exercised by BARDA, would increase the contract value to up to $107m.
As per the terms of the contract Emergent BioSolutions is expected to recognise revenues of up to $10m and pretax earnings of up to $5m during the second half of 2010.
The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26m doses in Building 55. This is an increase from the company’s current capacity of approximately 7-8m doses per annum.
The contract is also expected to fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental biologics license application (sBLA) for BioThrax at the expanded scale. Emergent BioSolutions expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.
Emergent BioSolutions has submitted to the FDA a supplemental biologics license application (sBLA), based on the data from a seven-year study by the Centers for Disease Control and Prevention, to reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations.
Fuad El-Hibri, chairman and CEO of Emergent BioSolutions, said: “We are proud to be working with HHS to scale-up manufacturing of BioThrax, the vaccine licensed by the FDA for the prevention of anthrax infection.”