ANNAPOLIS, Md., June 27, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that it has achieved an important technical milestone in its recombinant protective antigen (rPA) anthrax vaccine program. PharmAthene has successfully completed initial technology transfer of its manufacturing process for the bulk drug substance of its vaccine candidate, SparVax, at the 100 liter scale to a US-based manufacturing facility at Diosynth RTP. Activities to scale-up production to the final commercial 1,500 liter scale are underway.
"Completion of the technology transfer for SparVax to a domestic manufacturer represents a major technical milestone and significant achievement for our program," remarked Dr. Tom Fuerst, Executive Vice President and Chief Scientific Officer. "As part of this transition, our process sciences team was able to optimize the production process for SparVax increasing our bulk drug substance production yield approximately six-fold, further improving the cost effectiveness of our anthrax vaccine for the United States government. We are currently moving forward to complete the implementation of the GMP manufacturing processes and look forward to commencing additional clinical and non-clinical studies of SparVax in the coming months. Importantly, our achievement of this milestone will enable us to pursue additional advanced development funding."
Dr. Fuerst continued, "The benefits of rPA-based vaccines are well established, and we believe our program is at the forefront of efforts in this field. Most importantly, our rPA anthrax vaccine program meets a fundamental objective of Project BioShield, which was established to encourage the development and acquisition of newer, modern medical countermeasures that offer potential improvements in cost, convenience, safety and effectiveness for the U.S. government and its citizens."
PharmAthene's rPA anthrax vaccine program has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:
- SparVax second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE (recombinant butyrylcholinesterase) a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve agents and pesticides