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Cash injection for anthrax jab

By Anna Lewcock, 06-Nov-2007

Related topics: Materials & Formulation, Ingredients, excipients and raw materials

US firms Medarex and PharmAthene today announced that they are to receive additional funding from the US Government to support the ongoing development of their anthrax therapeutic, Valortim.

The partnering firms announced that the FY 2008 Department of Defense (DoD) appropriations bill includes $0.8m sum payable to PharmAthene on a cost reimbursement basis to fund the Valortim treatment, a human monoclonal antibody generated by Medarex technology.

While this is the third year in a row the company has received Congressional Appropriation to support continued development of the product, the 2008 sum is the lowest yet, with 2007 seeing a $1m figure, and 2006 coming in at $2.05m.

This, however, is unlikely to dampen the company's spirits, as just over a month ago PharmAthene announced a contract with the National Institutes of Health to develop the anthrax anti-toxin, in a deal worth up to $13.9m.

That contract brought the total amount of government funding allocated to Valortim to over $24m to date.

The latest DoD appropriations will go towards further study of the product using a promising new animal model of anthrax infection being developed at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), according to a statement from the company earlier today.

"It is currently very difficult to evaluate the therapeutic effect of new treatments because the mortality rate is very high and the time-course from anthrax exposure to death is quite rapid in existing anthrax models," said PharmAthene's Matthew Meldorf, head program director for Valortim.

The new animal model, however, will hopefully allow the researchers to more accurately determine the therapeutic potency of the antibody in animals.

The treatment itself is a fully human monoclonal antibody designed to protect against inhalation anthrax, the most lethal form of the disease caused by the Bacillus anthracis bacterium.

The investigational antibody targets a protein component of one of the lethal toxins produced by the bacteria, anthrax Protective Antigen (PA), which in turn facilitates the entry of two further destructive toxins, Lethal Factor (LF) and Edema factor (EF).

Valortim is designed to target the PA and protect cells from damage by anthrax toxins, and has been shown to be effective as a prophylactic and as a therapeutic treatment in preclinical studies.

The treatment was developed using Medarex' UltiMAb human antibody development system, which uses transgenic strains of mice in which gene expression is suppressed and replaced with human antibody gene expression.

Medarex believes its technology platform provides one of the most complete solutions available on the market, and sets the 'industry standard' thanks to the high affinity of the antibodies, the fact that they are 100 per cent human, and can be produced relatively efficiently in successive generations of transgenic mice.

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