May 29, 2014
PharmAthene, Inc. announced today that new analytical data from the Company’s SparVax® anthrax vaccine program were presented at the 114th General Meeting of the American Society for Microbiology (ASM), held recently in Boston, Massachusetts.
In a poster presentation entitled “Evidence Correlating Changes in Structure and Biological Activity for a Recombinant Protective Antigen (rPA) Anthrax Vaccine,” Dr. Bradford Powell, Director, Analytical Sciences at PharmAthene, presented the Company’s achievements in developing new analytical methods to measure how changes in the structural characteristics of rPA impact the potency and stability of the vaccine product, an important requirement for licensure by the United States Food and Drug Administration (FDA). Specifically, deamidation of rPA has been identified as the major pathway of degradation, and methods were developed to assess the state of deamidation over time and its relationship to vaccine potency. The results of the study confirmed a strong positive correlation between the structural and functional stability of rPA.
Dr. Peter Fusco, Vice President, Immunobiology and Assay Development for PharmAthene, commented, “Our new analytical assays for this rPA vaccine have yielded faster and more reliable methodology for monitoring the potency and stability of rPA. In fact, we appear to be making considerable progress towards achieving the ‘holy grail’ for stability-indicating assays, where the chemistry may ultimately be used to predict the biology. As a result, there are now data that we believe demonstrate the product remains potent and stable for at least two years, and subsequent changes are predicted to proceed at a slow rate.”
To date, 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.
PharmAthene is a biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene’s current biodefense portfolio includes the following product candidates:
- SparVax® - a next generation recombinant protective antigen (rPA) anthrax vaccine
- rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in May 2013, the Delaware Supreme Court issued its ruling on the appeal in our litigation with SIGA Technologies, affirming the Delaware Court of Chancery’s finding that SIGA was liable for breach of contract, reversing its finding of promissory estoppel, and remanding the case back to the Delaware Court of Chancery to reconsider the appropriate remedy and award of attorney’s fees and expert witness costs in light of the Delaware Supreme Court’s opinion. For more information about PharmAthene, please visitwww.PharmAthene.com.
Forward-Looking Statement Disclaimer
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: “will”; “potential”; “believe”; “anticipate”; “look forward”; “intend”; “plan”; “expect”; “estimate”; “could”; “may”; “should”; or similar statements are forward-looking statements. Such statements include, but are not limited to those referring to the outcome of the SIGA litigation and our ability to deploy our resources. PharmAthene disclaims any intent or obligation to update these forward-looking statements. Risks and uncertainties include, among others, risks associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the Company’s product candidates; our ability to demonstrate effectiveness of our technology and improve our 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, such as BARDA’s recent decision to de-scope the current SparVax® anthrax vaccine contract through a partial termination for convenience; awards of government contracts to our competitors; unforeseen safety issues; 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 annual reports on Form 10-K and quarterly reports on Form 10-Q under the caption “Risk Factors” and in its other reports filed with the U.S. Securities and Exchange Commission. In particular, there is significant uncertainty regarding the level and timing of sales of Arestvyr™ and whether and when it will be approved by the FDA and corresponding health agencies around the world. PharmAthene cannot predict with certainty if or when SIGA will begin recognizing profit on the sale thereof and there can be no assurance that any profits received by SIGA will be significant. In its May 2013 decision, the Delaware Supreme Court reversed the remedy ordered by the Delaware Court of Chancery and remanded the issue of a remedy back to the trial court for reconsideration in light of the Delaware Supreme Court’s opinion. As a result, there can be no assurance that the Delaware Chancery Court will issue a remedy that provides PharmAthene with a financial interest in Arestvyr™ and related products or any remedy. In addition, significant additional research work, non-clinical animal studies, clinical trials, and manufacturing development work remains to be done with respect to PharmAthene’s product candidates. At this point, future government funding to support development of Valortim®, rBChE, and SparVax® is unlikely and remains uncertain. It is also uncertain whether any of our product candidates 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 its website under the investor relations tab at www.pharmathene.com.