PharmAthene, Inc. Secures Exclusive License to PER.C6® Cell Line for Commercial Production of Recombinant Bioscavenger
ANNAPOLIS, Md., Jan. 14, 2013 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it has entered into an exclusive commercial license for the use of Percivia's proprietary PER.C6® technology platform in the production of PharmAthene's next generation recombinant butyrylcholinesterase (rBChE) bioscavenger.
The PER.C6® platform is a human, cell-based manufacturing system that enables the production of high quality, cost effective biological products for the life sciences industry with the added benefit of being fully human, unlike products manufactured using other expression systems.
"The PER.C6® platform offers many advantages over our initial transgenic approach, which successfully completed a Phase I clinical study. These include, the opportunity for higher production yields with substantially reduced production costs and the capability for rapid scale up in the event of a chemical weapons attack," commented Eric I. Richman, President and Chief Executive Officer. "Also, since it is based on a recombinant human cell line, the PER.C6® platform should enable a final product with a pharmacokinetic profile that more closely matches the naturally occurring butyrylcholinesterase found in human plasma."
"PharmAthene is proud to be working in collaboration with the Department of Defense (DoD) to develop innovative new medical countermeasure solutions to address significant national security threats. The potential use of chemical weapons represents a growing concern. If successful, our rBChE bioscavenger platform could provide an efficient and flexible manufacturing approach and a more cost-effective solution for the U.S. government to protect the U.S. military and citizens from chemical weapons," said Dr. John Troyer, Vice President, Chemical Defense Product Development. "We have made significant advances under our current contract with the DoD and expect to begin pharmacokinetic and efficacy testing of rBChE in animals in the coming months."
A recombinant form of human butyrylcholinesterase, a naturally occurring protein found in minute quantities in blood. BChE functions as a natural bioscavenger, to absorb toxins such as organophosphorous compounds (nerve agents) and certain pesticides, before they cause irreversible neurological damage.
About rBChE and Nerve Agents
PharmAthene is developing rBChE as a pre- and post-exposure therapy for casualties on the battlefield or civilian victims of nerve agent attacks. Non-clinical studies in animals of PharmAthene's first generation rBChE product candidate have demonstrated that rBChE 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).
Nerve agents belong to a class of compounds known as organophosphorus (OP) agents. OP nerve agents, such as sarin gas, soman, tabun or VX, enter the blood stream via inhalation or absorption through the skin. The nerve agents travel in the circulatory system to the brain and muscles causing the nerves to become over-stimulated which leads to massive convulsions and death in severe cases.
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 agents. PharmAthene's lead product development programs include:
- SparVax - next generation recombinant protective antigen (rPA) anthrax vaccine
- Recombinant BChE- novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
- Valortim® - fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, pursuant to a final judgment issued May 31, 2012 from the Delaware Court of Chancery, PharmAthene is entitled to 50% of the net profits over 10 years from all sales of SIGA Technologies' Arestvyr (formerly called ST-246®), a novel smallpox antiviral agent being developed by SIGA for the treatment and prevention of morbidity and mortality associated with exposure to the causative agent of smallpox, and related products, once SIGA receives the first $40 million in net profits from sales of Arestvyr. 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, 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 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 research work, non-clinical animal studies, human clinical trials, and manufacturing development work remain to be done with respect to rBChE. 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 http://www.pharmathene.com.
SOURCE PharmAthene, Inc.