GTC believes that ATryn? has the potential to achieve in excess of $1 billion of this potential DIC market in the U.S. alone, if successfully developed and approved for DIC associated with severe sepsis.
GTC is also nearing completion of the clinical studies necessary to support the filing of a Biologics License Application for ATryn? in the HD indication planned for the first quarter of 2008. These studies include an evaluation of the incidence of deep vein thrombosis and thromboembolisms in 17 additional hereditary antithrombin deficient patients undergoing surgical and pregnancy procedures that will be treated with ATryn? and a non-inferiority comparison to a total of 35 historical records of patients undergoing similar procedures that have been treated with plasma-derived antithrombin products. GTC plans on releasing top line data from these studies in the fourth quarter of 2007. GTC is in discussions for potential commercial partnering in the US market for ATryn?.
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