Sexual HealthPharmAthene Submits SparVax(TM) Regulatory Strategy To FDA
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug Administration (FDA) outlining the non-clinical and clinical development plans for licensure of SparVax(TM), a next generation recombinant protective antigen anthrax vaccine.
The FDA submission is in response to recent amendments issued by the Department of Health and Human Services (HHS) on April 15th and 22nd, 2009, to solicitation number RFP BARDA 08-15, outlining a requirement to develop and procure 25 million doses of a next generation rPA anthrax vaccine for the country"s civilian biomedical stockpile.
In September 2008, PharmAthene received notification from HHS that its proposal for SparVax(TM) had been deemed technically acceptable and within the competitive range for procurement consideration. Since that time, PharmAthene has been engaged in negotiations with HHS under the proposals process.
David P. Wright, President and Chief Executive Officer of PharmAthene, noted, "We are pleased to have met our stated goal of submitting our regulatory plan to FDA by May 21st, well ahead of the June 15th submission deadline. We feel we have presented a comprehensive and credible path for the ultimate licensure of SparVax(TM). We continue to maintain an ongoing dialogue with FDA, and anticipate an expeditious review of our development plan. In the meantime, activities under the SparVax(TM) program continue to advance uninterrupted under a development contract for SparVax(TM) originally awarded by the National Institute of Allergy and Infectious Disease (NIAID) and transferred to the Biomedical Advanced Research and Development Authority (BARDA) in April 2009. We look forward to the FDA"s review of our proposal, and to the contract award decision by HHS for the advanced development and procurement of next generation rPA anthrax vaccines."
About SparVax(TM)
SparVax(TM) is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection. Phase I and Phase II clinical trials involving more than 700 healthy human subjects have been completed and showed that SparVax(TM) appears to be well tolerated and induces an immune response in humans. These studies suggest that three doses of SparVax(TM), administered several weeks apart, should be sufficient to induce protective immunity. In preclinical studies SparVax(TM) has also demonstrated the capability to protect rabbits and non-human primates against a lethal aerosol spore challenge of the anthrax Ames strain.
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(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine
-- Third generation rPA anthrax vaccine
-- Valortim(R) - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
-- Protexia(R) - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
-- RypVax(TM) - a recombinant dual antigen vaccine for plague
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, including without limitation our bid related to SparVax(TM) under the HHS Request for Proposals for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile, 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, even with today"s submission to the FDA, there can be no assurance that the Company will be awarded a contract under the solicitation under RFP BARDA 08-15. Further, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for SparVax(TM). At this point there can be no assurance that SparVax(TM) will be shown to be safe and effective and approved by regulatory authorities for use in humans.
PharmAthene, Inc.