PharmAthene Achieves Anthrax Vaccine Program Milestone and Successfully Completes Technology Transfer
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, SparVaxTM, 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 SparVaxTM 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 SparVaxTM 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 SparVaxTM 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:
- SparVaxTM - 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
Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; "will"; "project"; "potential"; or similar statements are forward-looking statements. PharmAthene disclaims any intent or obligation to update these forward-looking statements other than as required by law. Risks and uncertainties include risk associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates, unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, the award of government contracts to our competitors, unforeseen safety issues, challenges related to the development, scale-up, technology transfer, and/or process validation of manufacturing processes for our product candidates, unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products, challenges related to the implementation of our NYSE Amex compliance plan, as well as risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission (the "SEC"). In particular, at this point there can be no assurance that PharmAthene's rPA product candidate will be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.PharmAthene.com.
SOURCE PharmAthene, Inc.
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