The contract modification, which is effective February 22, 2010 and extends until December 31, 2012, provides for up to $61m during a ‘base period’ of performance with options for an additional $17m on a cost reimbursement plus fixed fee basis in additional advanced development funding for SparVax. Provided that certain milestones are achieved, and that all contract options and extensions are exercised by the government, the contract has a total potential value of $78.4m.
The activities outlined under the contract modification are designed to continue existing development activities already under contract (HHSO100200900103C). The modification will include non-clinical safety and efficacy studies, assay development and qualification, and process scale up and validation.
Phase I and Phase II clinical trials involving 770 healthy human subjects have been completed and demonstrated that SparVax appears to be well tolerated and immunogenic in humans. These studies suggest that three doses of SparVax, administered over a 56 day period, are sufficient to induce protective immunity. The vaccination regimen for the currently licensed anthrax vaccine, BioThrax, requires five doses over a period of eighteen months.
Including the additional funding announced today, PharmAthene’s SparVax program has been awarded funding commitments from the US government totaling up to $213.2m.
David Wright, president and chief executive officer, said: “”There is widespread acknowledgement among various government agencies that the US must develop and stockpile a second generation anthrax vaccine employing modern vaccine technology that offers the potential for improved safety, convenience and enhanced cost effectiveness.
“New and improved anthrax vaccines, based on modern state-of-the-art recombinant vaccine technology, incorporate significant product development and technological advancements and ultimately may provide meaningful health and economic advantages.
“We believe that, if awarded, funding provided under the BAA, along with the additional funding announced today, could be sufficient to advance SparVax to a stage where it will be eligible for consideration for a Project BioShield procurement contract.”
In addition to the funding announced today, on February 1, 2010 PharmAthene also submitted a White Paper seeking further development funding for SparVax, in response to a Broad Agency Announcement.
SparVax is a second generation recombinant protective antigen (rPA) anthrax vaccine targeted for future procurement in the US Strategic National Stockpile (SNS). It is a highly purified recombinant protective antigen vaccine being developed for pre and post exposure protection against anthrax infection.