Funds will support development, validation, vaccine trials, and regulatory clearance.
Emergent BioSolutions has been awarded a potentially $107 million U.S. government contract to develop a manufacturing process that will more than triple the production capacity of its FDA-approved Anthrax vaccine, BioThrax, at the firm’s Building 55 facility in Lansing, MI. The aim is to increase manufacturing capacity of the prophylactic vaccine from 7–8 million doses a year to 26 million doses, Emergent notes. The contract has been awarded by the U.S. Department of Health and Human Services’ Office of the Biomedical Advanced Research and Development Authority (BARDA).
Emergent says it has developed a comprehensive plan to demonstrate the comparability of the new large-scale process with the current manufacturing process for BioThrax. The contract includes funding to support relevant process development, assay validation, and fill/finish activities along with any nonclinical and clinical studies that may be required to test the vaccine generated by the larger-scale manufacturing process. Emergent confirms that it has also factored into its development plan the relevant regulatory activities to support the submission of an sBLA for BioThrax manufactured at the expanded scale.
The nuts and bolts of the deal include a two-year base period of performance valued at $54.6 million and an additional three option years that, if exercised by BARDA, would take the contract value up to its $107 million maximum. Emergent says that as a result of the contract it expects to realise revenues of up to $10 million and pretax earnings of up to $5 million during the second half of this year.
The firm claims that since 1998 the U.S. government has obtained over 42 million doses of BioThrax, and over 9.6 million doses have been administered. In June Emergent reported the completion of international sales and deliveries of BioThrax to a number of governments of allied nations. International sales of the vaccine generated revenues of approximately $2.3 million in the second quarter.
The bulk of Emergent’s revenues are still derived from sales of BioThrax to the U.S. government, the firm states. Product revenues of $217.2 million were reported in 2009, compared with $169.1 million in 2008.
Emergent is focused on the development, manufacture, and commercialization of vaccines and antibody therapies against infectious diseases. The firm’s pipeline includes therapeutic and preventive products for anthrax, tuberculosis, typhoid, flu, and chlamydia.
Emergent’s Anthrax pipeline has received continued grant support from U.S. government agencies. The pipeline includes advanced anthrax prophylactic vaccines, a recombinant protective antigen therapeutic vaccine for post-exposure vaccination, a polyclonal anthrax immune globulin product, and a fully human mAb candidate.