ANNAPOLIS, Md., July 8 PharmAthene, Inc. (NYSE: Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it continues to make solid progress in its lyophilized recombinant Protective Antigen (rPA) anthrax vaccine development program. The Company has recently demonstrated that its lyophilized rPA vaccine candidate is structurally stable and potent at various temperatures up to and including 70 degrees centigrade. In addition, new non-clinical data, which will be presented next week at the upcoming 2010 International Conference on Emerging Infectious Diseases, July 11-14 in Atlanta, Georgia, demonstrate improved immunogenicity of the lyophilized vaccine formulation when compared to the liquid formulation.
Eric I. Richman, President and Interim Chief Executive Officer, commented, "PharmAthene is committed to working with and serving the needs of our customer, the United States government, through the innovation and development of next generation anthrax vaccines that offer important enhancements over first generation products. We have developed a portfolio of leading anthrax countermeasures encompassing second and third generation anthrax vaccine candidates based on rPA and a novel anti-toxin therapeutic, which meet these criteria. We continue to work closely with our partners at the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority to advance these important medical countermeasures to protect Americans at home and on the battlefield."
Various government agencies, as well as the Institute of Medicine, have acknowledged the urgent need to develop and stockpile next generation anthrax vaccines employing modern vaccine technology, which offer the potential for improved safety, convenience, cost-effectiveness, and more rapid immunity. PharmAthene's second generation rPA anthrax vaccine candidate, SparVax(TM), is being developed to fulfill these requirements.
Mr. Richman continued, "As we focus on meeting the needs of our customer today with the development of improved, second generation vaccines, we are also working concomitantly to innovate the next generation of anthrax vaccines that will deliver even greater benefit to our nation and its citizens. One of the goals of our rPA program is to develop a stable cold-chain-free vaccine, which could be stored and distributed at room temperature - an important advantage for deployment in the civilian Strategic National Stockpile. Although at an earlier stage of development, a lyophilized formulation of rPA could meet the requirements for a cold-chain-free vaccine and we are enthusiastic about the prospects for this program."
The Company has recently achieved an important milestone in its NIH sponsored lyophilized rPA program and completed the manufacture of approximately 14,000 doses of lyophilized rPA vaccine, produced under cGMP (current Good Manufacturing Practices) conditions, which is intended to be used in ongoing development work.
Funding for the lyophilized rPA vaccine program was provided under a Challenge grant (UC1 AI067223-01) from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
According to the Centers for Disease Control and Prevention, anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals and can also infect humans. Symptoms of disease vary depending on how the disease is contracted, but usually occur within seven days after exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and gastrointestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax is often fatal, even if treated by antibiotics. Currently, antibiotics are the only drugs available for therapeutic or prophylactic use for inhalation anthrax, and post-exposure prophylaxis is the only FDA-approved indication for such products. However, antibiotic therapy, while useful, is believed to be associated with a number of limitations, including: (1) lack of activity against the toxins produced by the B. anthracis bacteria, (2) need for long-term dosing to achieve full protection, complicated by side effects and non-compliance, (3) lack of efficacy when administered late in the anthrax disease cycle, and (4) lack of effectiveness against multi-drug resistant or genetically engineered strains of anthrax.
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:
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 risks 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 Form 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, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for our lyophilized rPA anthrax vaccine candidate. At this point there can be no assurance that this 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.
-- SparVax(TM) -- 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
SOURCE PharmAthene, Inc.