ANNAPOLIS, Md., Feb. 1 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it has submitted a White Paper in response to the Broad Agency Announcement (Solicitation Number: BAA-BARDA-09-34) issued by the Biomedical Advanced Research and Development Authority (BARDA) for the Advanced Research and Development of Chemical, Biological, Radiological and Nuclear Medical Countermeasures. In December 2009, this BAA was specially modified and extended to accommodate rPA-related submissions.
David P. Wright, President and Chief Executive Officer of PharmAthene, commented, "In consultation with BARDA, today PharmAthene submitted a White Paper for advanced development of SparVax™ in response to the BAA. If BARDA finds our submission acceptable, a formal proposal will be requested. We believe that, if awarded, funding provided under this BAA, along with potential additional funding under our existing contract with BARDA, will be sufficient to advance SparVax™ to a stage where it will be eligible for consideration for a Project BioShield procurement contract."
"There has been widespread acknowledgement across the scientific community of the need for a next-generation anthrax vaccine that offers the potential for improved safety, convenience and cost-effectiveness. SparVax™ is the leading rPA-based vaccine and is well positioned to meet these requirements. We look forward to continuing our work with the government to develop the necessary medical countermeasure to successfully deter or quickly respond to a biologic attack and save American lives," continued Mr. Wright.
SparVax™ is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection. This product candidate employs modern vaccine technology to provide a highly purified and well characterized modern vaccine for intended use by the military and civilian Strategic National Stockpile. Phase I and Phase II clinical trials involving more than 750 healthy human subjects have been completed and showed that SparVax™ appears to be well tolerated and induces an immune response in humans. These studies suggest that three doses of SparVax™, administered several weeks apart, should be sufficient to induce protective immunity. In non-clinical studies SparVax™ has also demonstrated the capability to protect rabbits and non-human primates against a lethal aerosol spore challenge of the anthrax Ames strain. The clinical and non-clinical studies for SparVax™ have been carried out under contracts with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health.
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
- Third generation rPA anthrax vaccine
- Valortim® -- a fully human monoclonal antibody for the prevention and treatment of anthrax infection
- Protexia® -- a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
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"; or similar statements are forward-looking statements. PharmAthene disclaims, however, any intent or obligation to update these forward-looking statements. 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, 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, 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, there can be no assurance that the Company will receive any additional funding from the government for SparVax™. Further, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for SparVax™. At this point there can be no assurance that SparVax™ 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.