>>PharmAthene Awarded Up to $13.9 Million NIH Contract to Develop Anthrax Anti-Toxin, Valortim(TM) with Medarex
Wednesday September 26, 4:00 pm ET
Total Government Funding Committed to Valortim(TM) Exceeds $24 Million
ANNAPOLIS, Md. and PRINCETON, N.J., Sept. 26 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (AMEX: PIP - News), a biodefense company developing medical countermeasures against biological and chemical threats, and Medarex, Inc. (Nasdaq: MEDX - News), a leading monoclonal antibody company, today announced that the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the National Institutes of Health (NIH), has awarded PharmAthene a contract for the advanced development of Valortim(TM), a fully human monoclonal antibody generated by Medarex's UltiMAb® technology that is being co-developed by the two companies. The up to $13.9 million contract supports the development of Valortim for use as an anti-toxin therapeutic to prevent and treat inhalation anthrax infection. The contract is effective as of September 28, 2007 and will be incrementally funded through 2009. Funding for the contract's initial fiscal year could reach up to $10.3 million.
"We are very pleased to have the NIAID/BARDA's continuing support for the Valortim program and look forward to a long-term and highly productive relationship to achieve our mutual objective of developing effective countermeasures to biological and chemical weapons of mass destruction," said David P. Wright, President and Chief Executive Officer of PharmAthene. "This award furthers PharmAthene's strategy of securing a leadership position in biodefense. We believe Valortim possesses favorable characteristics that make it an ideal choice for procurement in the Strategic National Stockpile under Project BioShield. We look forward to continuing to advance the development of this important therapeutic."
"We commend PharmAthene for their excellent work on the NIAID/BARDA proposal," remarked Israel Lowy, M.D., Ph.D., Senior Director of Infectious Disease for Medarex. "PharmAthene has been instrumental in securing this follow-on external funding to advance the development of Valortim toward potential commercial success. The initial work conducted at Medarex on Valortim has demonstrated a novel mechanism of action, animal efficacy, favorable human safety and pharmacokinetic data, and development of an efficient and scalable manufacturing process. We are pleased that continued funding for this project may help PharmAthene secure a contract to supply Valortim to the government and obtain FDA approval."
"The latest contract from NIAID/BARDA brings the total amount of government funding allocated to Valortim to date to over $24 million," remarked Valerie Riddle, M.D., Vice President and Medical Director for PharmAthene. "This is the second substantial government funding contract PharmAthene has been awarded in less than a year."
"We look forward to a long-term, cooperative and highly productive relationship with the U.S. Government to achieve our mutual objective of ensuring protection of the U.S. population against biological and chemical threats," said Dr. Riddle.
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSN272200700033C.
About Valortim
Valortim (MDX-1303) is a fully human antibody designed to protect against anthrax infection, including inhalation anthrax, the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. The investigational antibody is designed to target a protein component known as the anthrax protective antigen (PA) of the lethal toxin complex produced by the bacterium. The anthrax protective antigen is believed to initiate the onset of the illness by attaching to cells in the infected person, and then is believed to facilitate the entry of additional destructive toxins into the cells. Valortim is designed to target anthrax protective antigen and protect the cells from damage by the anthrax toxins.
Valortim has been administered intravenously and intramuscularly to healthy human volunteers in a completed phase I study, was well tolerated at doses as high as 20 mg/kg (IV), and was not immunogenic. These study results were presented at the 2006 Annual Meeting of the Infectious Diseases Society of America. Pharmacokinetic analysis suggested that doses as low as 1 mg/kg resulted in circulating levels of antibody after a month, with a similar potency for neutralizing anthrax toxin in vitro as was seen with serum obtained from subjects who had been vaccinated with anthrax vaccine.
Preclinical studies suggest that Valortim has the potential to provide significant protection against anthrax infection when administered prophylactically (prior to the emergence of symptoms of anthrax infection) and also may increase survival when administered therapeutically (once symptoms become evident).<<
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