, June 9, 2014
/PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP) announced today that the U.S. Patent and Trademark Office issued U.S. patent number 8,729,245 to PharmAthene, with claims that cover methods for the production of its recombinant butyrlcholinesterase (rBChE) bioscavenger in mammalian cells. PharmAthene is initially developing rBChE as a pre- and post-exposure therapy for military and civilian victims of nerve agent attacks.
"Organophosphorus compounds, including nerve agents and certain pesticides, are rapidly debilitating and lethal. Overexposure to these agents can cause the body's nerves to become over-stimulated, which leads to massive convulsions and death in severe cases," commented Dr. John Troyer, Vice President, Chemical Defense Product Development for PharmAthene. "Because of its unique ability to neutralize these compounds, we believe that our bioscavenger has a wide range of potential biodefense and commercial applications. In addition to its application as a nerve agent medical countermeasure, rBChE may also have utility addressing pesticide overdose or certain orphan drug indications such as pseudocholinesterase deficiency, which is a condition that results in increased sensitivity to certain muscle relaxant drugs used during general anesthesia."
BChE is a naturally occurring protein found in minute quantities in blood. It functions as a natural bioscavenger to absorb toxins such as organophosphorous compounds, including nerve agents and certain pesticides, before they cause irreversible neurological damage.
Non-clinical studies in animals of a first generation rBChE product candidate have demonstrated that it has the potential to provide significant protection against chemical nerve agent poisoning when administered prophylactically (prior to exposure to nerve agent) and also may increase survival when administered therapeutically (following nerve agent exposure).
"The use of chemical weapons on the battlefield or among civilians represents a potentially grave concern and there remains a clear need for more efficacious chemical weapons countermeasures. We believe that, if successful, our rBChE bioscavenger candidate could provide a more cost-effective and flexible solution to protect the U.S. military and citizens from the harmful effects of chemical weapons," concluded Dr. Troyer.
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 visit www.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; and the potential protections to be provided by rBChE bioscavenger. 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 Court of Chancery 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.
SOURCE PharmAthene, Inc.