PharmAthene Overview
PharmAthene was formed to address the urgent biosecurity needs of this Nation and its Allies. Since the terrorist attacks in 2001 and the subsequent deliberate anthrax exposure to the U.S. population, the vulnerability of this Nation to a wide array of threats has come into sharp focus. Additionally, the Nation has recognized how woefully unprepared it is for future attacks. The U.S. Government has responded by allocating a significant amount of funding to develop technologies and products to address threats through development of the Department of Homeland Security and unprecedented funding for the biodefense market through the recently enacted Project BioShield Law. As a Company founded on the principle of developing a comprehensive array of countermeasures to biological and chemical terrorism, PharmAthene has demonstrated its ability to achieve its mission of being the leading developer and provider of countermeasures to potential bioweapons and is well positioned to be meet the urgent needs of the U.S. Government under the Project BioShield legislation.
PharmAthene is engaged in the discovery and development of new human therapeutics and prophylactics for the treatment and prevention of morbidity and mortality from exposure to chemical and biological weapons. PharmAthene's mission is to seize leadership in this emerging area by developing a portfolio of products urgently needed by the U.S. Government and its Allies. PharmAthene has two products under development that are intended to provide protection from anthrax and chemical threats. Beyond its initial focus in biodefense, PharmAthene intends to identify and develop dual-use technologies which have applications and indications in broader commercial markets.
PharmAthene's core strengths are its:
* Unique focus in biological and chemical defense products including Valortim™, an anthrax human monoclonal antibody, and Protexia™, a recombinant form of human butyrylcholinesterase (huBChE). * Experienced management team which has been previously involved in the development and marketing of over 24 pharmaceutical products. * Substantial capitalization and access to U.S. capital markets. * Strong investor base including MPM Capital, Healthcare Ventures, Bear Stearns Health Innoventures, MDS Capital and the Ontario Teachers Pension Plan.
PharmAthene was founded in 2001 by Mr. Joel McCleary, a private investor, Drs. John Mekalanos, John Collier and Stephen Lory of Harvard Medical School, and Dr. John Young of The Salk Institute for Biological Studies.
PharmAthene's Strategy
To seize leadership in biodefense, PharmAthene has assembled and will continue to build a strong portfolio of development-stage products, which it believes are essential for the biosecurity needs of the United States and its Allies. These products must meet certain criteria including demonstration of proof of concept, demonstrated interest by the U.S. Government in procurement, and a clearly defined development and regulatory strategy. PharmAthene has two products currently in development: Valortim™, a human monoclonal antibody against anthrax toxin and Protexia™, a recombinant human butyrylcholinesterase for nerve agent poisoning. PharmAthene is therefore well positioned to be a leading provider of urgently needed products to the U.S. Government's Strategic National Stockpile.
Building on its core business in biodefense, PharmAthene will remain opportunistic in identifying platform technologies with immediate relevance in biological and chemical defense and future applications in broader commercial markets. PharmAthene expects to build capability, capacity, and financial strength through its existing biological and chemical defense programs in anthrax (Valortim™) and organophosphate bioscavengers (Protexia™), and then leverage these capabilities for other commercial non-biodefense products. For example, PharmAthene will explore certain applications of one of its compounds for uses in the treatment of drug addiction and substance abuse. By doing so, PharmAthene will establish a core business and stable base of operations and create a manufacturing and commercial infrastructure. This stable base will be directly applicable to developing and commercializing novel products for broader consumer markets.
PharmAthene's Portfolio of Products
Anthrax is generally regarded as the single most important and imminent threat to North American biosecurity. Inhalational anthrax infection, caused by exposure to the bacterium Bacillus anthracis, is a serious disease with fever, shortness of breath and low blood pressure appearing within several days of exposure. There is a 95% to 100% mortality rate if left untreated, and at least a 50% mortality rate in patients treated aggressively with antibiotics. There is no effective therapy for the treatment of symptomatic anthrax infection and antibiotics have proven to be only 50% effective. Currently, PharmAthene is developing Valortim™, a fully human monoclonal antibody for prophylaxis as well as a therapeutic.
Valortim™
PharmAthene entered into a collaboration agreement with Medarex, Inc. (NASDAQ: MEDEX) to co-develop its fully human monoclonal antibody, Valortim™. An antibody is a protein produced by the body, in response to the introduction of a foreign substance called an antigen, that fights the invading organism. The antigen elicits a broad response including the release of antibodies to neutralize the antigen by binding to different sites on the antigen and neutralizing any activity. A monoclonal antibody is a single clone of an antibody that is directed to a specific site on the antigen.
Valortim™ is a high affinity, fully human monoclonal antibody to Bacillus anthracis protective antigen (PA). It is designed to target and bind to PA cells and protect healthy human cells from infiltration by the toxins LF and EF. Anthrax spore challenge studies in animals have demonstrated both pre-exposure protection and post-exposure protection by Valortim™ against anthrax infection. Its potency and unique mechanism of action differentiate this product from other options the Government may consider. The U.S. Government awarded PharmAthene's partner in the development of Valortim™ two separate grants of up to US $7.2 million over the next three years.
Protexia™
PharmAthene is also developing Protexia™, a recombinant form of human butyrylcholinesterase (BChE) for clinical use in the treatment of organophosphate (OP) intoxication due to exposure to chemical nerve agents (soman, sarin, tabun and VX). Protexia™ is not only a potential pre-treatment or treatment to protect against acute nerve agent attack, but also an agent to protect against long-term adverse effects of nerve agents. Protexia™ can also catalyze the hydrolysis of cocaine and short-acting muscle relaxants (succinylcholine and mivacurium). Protexia™ will be developed as an effective treatment for cocaine intoxication as well as succinylcholine and mivacurium-induced apnea (applications beyond chemical warfare/terrorism). |