By Calvin Biesecker
Biopharmaceutical company Emergent BioSolutions [EBS] on Friday said it has received a potential five-year, $186.6 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to resume development of a next generation recombinant protective antigen (rPA) anthrax vaccine product candidate.
The initial award is for $51 million for a two-year base period that will fund activities related to process characterization and assay validation, as well as formulation and stability studies. The contract is cost-plus fixed-fee.
The award comes more than two years after Emergent BioSolutions acquired the assets and rights to an rPA anthrax vaccine product candidate and related technology from VaxGen [VXGN] for $2 million, plus $8 million in potential milestone payments. VaxGen, largely on its own dime, had been developing the rPA-based vaccine under a potential $877 million contract awarded in 2004 from the Department of Health and Human Services (HHS) as part of Project BioShield.
That contract was terminated for default by HHS in December 2006 because VaxGen was unable to begin clinical trials of the drug that month as required, which in turn were being held up because the Food and Drug Administration had concerns about the vaccine candidate’s stability in storage (Defense Daily, Dec. 21, 2006). For VaxGen, that was basically the end of its efforts to develop the next generation anthrax vaccine because under the contract terms the company was only going to be paid when it delivered the vaccine.
Since acquiring the rPA assets from VaxGen, Emergent has been working to continue development of the technology in advance of its new contract. The company, which currently supplies HHS with current anthrax vaccine called BioThrax, is also developing other anthrax vaccines. The company recently received an award for phase II clinical trials of AV7909. Phase II trials of the rPA-based candidate would come as part of the future milestone-based options under the new award.
“We applaud the U.S. Government’s commitment to the biodefense industry and to the development of additional medical countermeasures using multiple technologies and additional sites to address the acknowledged anthrax threat,” Fuad El-Hibri, chairman and CEO of Emergent, said in a statement. “This award solidifies Emergent’s anthrax franchise and reaffirms our position as a leading supplier to, and developer for, the U.S. government of anthrax biomedical countermeasures.
BARDA is a component of HHS that was established in part due to the failed anthrax vaccine development scheme the government undertook with VaxGen, which basically put all the financial risk and burden on the contractor.
Under the new rPA anthrax vaccine effort, if Emergent’s effort to develop the final formulation and test of its stability after two years is successful, HHS can extend the contract annually for up to three years to support scale-up and optimization for large-scale manufacturing and additional animal studies needed to apply for FDA approval of the vaccine.
HHS said on Friday that the new award enhances the pipeline of potential products and increases the chances of success in developing a new anthrax vaccine.