April 7, 2014
PharmAthene, Inc. announced today that it has received notice from the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), advising the Company of its decision to de-scope the current SparVax® anthrax vaccine contract through a partial termination for convenience. BARDA will provide additional guidance to PharmAthene on the contractual changes, following which PharmAthene will evaluate its options with respect to its SparVax® program.
PharmAthene has been developing SparVax® to address a requirement for a modern anthrax vaccine based on state-of-the-art vaccine technology. The decision follows an In Process Review (IPR) meeting where, despite the Food and Drug Administration (FDA) placing SparVax® on clinical hold, PharmAthene reported progress on the SparVax®program. Since the previous IPR meeting in 2011, PharmAthene has demonstrated the following achievements:
- Development of a high yield GMP manufacturing process with the capability to deliver >150 million doses annually to the Strategic National Stockpile
- Equivalent survival to BioThrax® in a New Zealand White rabbit anthrax aerosol spore challenge model
- Minimum two year stability and potency of SparVax®
- Development of novel analytical assays; a new immunopotency assay has been accepted by the FDA to measure anthrax vaccine stability
- Economic advantage over the currently licensed vaccine offering potential savings of up to $750 million to taxpayers
- Establishment of surge capacity for manufacturing
Phase 1 and Phase 2 clinical trials involving 770 healthy subjects have demonstrated that SparVax® appears to be well tolerated and capable of producing an immune response in humans.
These studies suggest that three doses of SparVax® should be sufficient to induce protective immunity. Non-clinical animal studies of SparVax® have demonstrated the capability to protect rabbits and non-human primates against lethal anthrax aerosol spore challenge.
Eric I. Richman, President and Chief Executive Officer, stated, “We believe that SparVax®is the most advanced next generation anthrax vaccine currently in development and we intend to explore all of our options, including seeking partnering or financing opportunities to continue our development efforts. We await more information from BARDA.”
PharmAthene’s rPA anthrax vaccine program has been supported by funding from the National Institute of Allergy and Infectious Disease, National Institutes of Health, and the Biomedical Advanced Research and Development Authority.
PharmAthene is engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® - a next generation recombinant protective antigen (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In May 2013, the Delaware Supreme Court issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Delaware Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Delaware Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Delaware Supreme Court’s opinion. For more information about PharmAthene, please visit www.PharmAthene.com.