Department of Defense Awards $5.7 Million Contract to PharmAthene for Nerve Agent Medical Countermeasure Program
Flexible Manufacturing System Could Potentially Streamline Development Approach and Improve Cost Effectiveness
PR Newswire
ANNAPOLIS, Md., Aug. 16, 2011
ANNAPOLIS, Md., Aug. 16, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the Company has been awarded a $5.7 million contract under a Department of Defense (DoD) Broad Agency Announcement for studies directed at the development of an advanced expression system for the bioproduction of its nerve agent medical countermeasure program.
rBChE is a recombinant form of a naturally occurring protein, human butyrylcholinesterase (BChE), which is found in minute quantities in blood. It functions as a natural bioscavenger, like a sponge, to absorb toxins such as organophosphorous poisons (nerve agents) and certain pesticides, before they cause irreversible neurological damage.
Preclinical studies in animals suggest 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).
Funding under the new contract, which has a base period of 18 months, will be used to evaluate a novel mammalian cell-based manufacturing system for rBChE. If successful, this platform could potentially streamline the development approach for rBChE and increase the production yield, manufacturing flexibility, and cost-effectiveness of this program.
"We have considerable experience in the production and evaluation of recombinant BChE," remarked Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer. "This contract builds upon the body of knowledge we have established over the years with a specific focus on the expression of rBChE using a novel mammalian cell line that has been used for the advanced-stage bioproduction of other recombinant proteins with considerable FDA oversight and review."
Dr. Fuerst continued, "PharmAthene's commitment to innovation has enabled us to continue to develop and advance novel medical countermeasures, based on 21st century biopharmaceutical processes. These contracted studies will advance the state of the art of rBChE technology and, we believe, will position us to better meet the needs of our customer, the U. S. government. PharmAthene's approach is consistent with the government's initiative to support the use of flexible, state-of-the-art technologies to meet the needs of both the military and civilian strategic stockpiles. We are excited about the potential for a mammalian cell-based manufacturing system, which may yield improvements in a second generation product profile, and look forward to a productive collaboration with the DoD in the conduct of these studies that are key to the advancement of important new prophylactic and therapeutic medical countermeasures."
About rBChE
PharmAthene is developing rBChE as a pre-exposure prophylaxis and post-exposure therapy for casualties on the battlefield or civilian victims of nerve agent attacks. 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 weapons. PharmAthene's lead product development programs include:
SparVaxTM - a Phase II, second generation recombinant protective antigen (rPA) anthrax vaccine
Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
rBChE (recombinant butyrylcholinesterase) - a medical countermeasure for nerve agent poisoning by organophosphate compounds, including nerve gases and pesticides
For more information about PharmAthene, please visit http://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.
CONTACT: Stacey Jurchison, PharmAthene, Inc., +1-410-269-2610, [email protected]
Web Site: http://www.pharmathene.com