CounterVail Corporation

May, 2007
Final Market Opportunity Analysis Completed
Technical Due Diligence Completed
Initial Discussion with World Health Organization
Initial Discussion with Pan-American Health Organization
Initial Discussion with BARDA
Patent submissions in 25 Countries finalized and filed
June, 2007
Corporate Counsel Engaged
Countervail Incorporated
Corporate Governance Documents Completed
Master Licensing Agreement Negotiated with University of Maryland Baltimore
July, 2007
Patent Counsel Engaged
Master License Agreement Signed with University of Maryland Baltimore
PHEMCE Participation (Public Health Emergency Medical Countermeasures Enterprise)
August, 2007
BARDA Industry Day Participation and Presentation
(Biomedical Advanced Research and Development Authority)
Initial Seed Financing secured
BARDA Committee Presentation
ARMY Presentation
September, 2007
FDA Consultant Engaged
NIH Presentation
UMB Update Completed
October, 2007
Pre-, Pre-IND Committee Discussion and Presentation (FDA, NIH , DOD and BARDA)
November, 2007
First Round Meetings with potential Contract Manufacturing Organizations
BARDA Committee Update
December, 2007
Initial Discussions with Contract Research Laboratories for GLP Studies
UMB Update
January, 2008
Meetings with Contract Research Laboratories for GLP Studies
February, 2008
Meetings with DTRA (Defense Threat Reduction Agency)
March, 2008
Meetings and Presentation with NINDS
(National Institute of Neurological Disorders and Stroke)
Presentation at New Jersey Economic Development Council
Presentation at New Jersey Technical Council
UMB Update Meeting
April, 2008
Meetings and Presentation at 2nd Annual CounterACT Network Research Symposium
(Countermeasures against Chemical Threats)
Meetings and Presentation at North Carolina Venture Capital Symposium
May, 2008
Scheduled Presentation at New Jersey Bio-Terrorism Conference
June, 2008
Countervail Corporation awarded $ 25,000 in matching business development funding from the NC BioTech Center in support of FDA Pre-IND activities for product commercialization.

Chemical Threats

Galantamine is an acetylcholinesterase inhibitor. Its primary mode of protective action is to reversibly bind to acetylcholinesterase and block the irreversible binding of the organophosphate toxin. The competitive binding characteristics of galantamine prevent the build-up of acetylcholine and protect the victim from the potentially fatal effects. Pre-IND studies have shown galantamine to be effective in protecting 100% of the animals tested at nerve gas exposure levels of two times the lethal dose. Galantamine not only protects the peripheral nervous system but due to its nature as a small uncharged molecule, crosses the blood-brain barrier to protect the central nervous system from longer term detrimental effects. Guinea pig studies have shown protection from neurodegeneration in the hippocampus, pyriform cortex, and amygdale by galantamine against lethal doses of OPs.

Galantamine can be used prophylactically to prepare for anticipated organophosphate poisoning (nerve gas attack and pesticide application). It can also be used after exposure to treat acute cases. Studies by the primary investigator support effective use of galantamine up to 25 minutes post exposure.

Since galantamine is a small molecule, it does not present the immunological problems that larger molecules such as enzymes and antibodies are subject. Multiple doses will not produce immunological sensitivity resulting in a negative immune response such as anaphylactic shock.

Recent data support the use of galantamine without the need for an anti-muscarinic agent such as atropine. As such, significant value is added by eliminating the cost and the adverse effects caused by atropine.

Although galantamine is categorized as an acetylcholinesterase (AChE) inhibitor, it is unique in that it is the only AChE inhibitor that also rescues nicotinic receptors believed to be responsible for its superior antidotal effectiveness.

In comparison to other OP antidotes under development, galantamine is already being produced at economy of scale levels and on the market for another indication. As a result a substantial amount of safety data exists in a broad range of populations and supply of the active pharmaceutical ingredient is readily available.