ANNAPOLIS, Md., April 12, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer, presented a comprehensive update on the Company’s novel SparVax rPA anthrax vaccine program at the 2012 World Vaccine Congress, held at the Gaylord National Convention Center in Washington, DC, April 11-14, 2012.
SparVax is being developed to meet the government’s need for an improved second generation anthrax vaccine that is safe, convenient, more cost-effective, and capable of providing rapid manufacturing scale-up in response to a national security emergency.
New data based on a recent analysis of previous human clinical trial immunogenicity data and non-clinical animal study results for SparVax suggested a preliminary estimate of efficacy in humans of over 90% protection and nearly 100% protection based on a 6- and 12-month booster dose, respectively. This analysis is based on a correlate of protection established under the Animal Rule in accordance with FDA guidelines.
“The benefits of rPA-based anthrax vaccines are well established and we believe our program is at the forefront of efforts in this field,” remarked Dr. Fuerst. “We are very excited about the progress we continue to make in our SparVax program. Beyond our clinical successes, a key differentiator is our robust manufacturing process, which enables production of a highly characterized, highly purified and stable vaccine in sufficient scale required to meet the government’s mandate for a modern, second-generation rPA-based anthrax vaccine. We look forward to commencing additional Phase II clinical testing of SparVax later this year and to continuing a very productive collaboration with our partners in government to address this important national security requirement.”
Dr. Fuerst’s presentation also highlighted the important technical milestones that PharmAthene achieved for its SparVax program during 2011. These include completing technology transfer of the manufacturing process and cGMP manufacturing of the final drug product at full commercial scale. SparVax also demonstrated 36 months of final drug product stability, a particularly noteworthy achievement, as stability has historically been a stumbling block for other rPA vaccine programs. PharmAthene also increased rPA yield six-fold at the bulk drug substance stage, which is highly significant in terms of being able to fill government stockpile requirements.
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 SparVax
SparVax is a novel second generation anthrax vaccine being developed to protect against inhalation anthrax, the most lethal form of anthrax infection in humans. The vaccine contains highly purified recombinant protective antigen (rPA) and has been shown to stimulate protection against anthrax by eliciting a specific immune response to one of the primary proteins excreted by the Bacillus anthracis organism. Unlike the first generation anthrax vaccine and other rPA-based anthrax vaccines in development, SparVax is produced using E. coli, which enables a much more robust and scalable manufacturing process. In addition, SparVax is capable of being produced at greater than 150 million rPA vaccine equivalent doses per year (at 50 mcg per dose) using a single 1,500-liter fermentor. The unique manufacturing process also mitigates the detrimental effect of proteases. SparVax is expected to undergo additional Phase II clinical testing in 2012.
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 - a second generation recombinant protective antigen (rPA) anthrax vaccine
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
- rBChE - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
In addition, pursuant to an opinion issued September 22, 2011 from the Delaware Court of Chancery, PharmAthene is entitled to 50% of the profits over 10 years from all sales of SIGA Technologies’ ST-246 - a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox (once SIGA earns $40 million in net profits from sales of ST-246.)
For more information about PharmAthene, please visit www.PharmAthene.com.
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.
