TORONTO, Sept. 23 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX: SDI) today announced that it has agreed to key terms with Toray Industries Inc. of Japan to obtain the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic for the treatment of sepsis that removes endotoxin from the bloodstream. Under the terms of the agreement, the Company will seek FDA approval for a combined product for the treatment of severe sepsis that will include Toraymyxin(TM) and Spectral's Endotoxin Activity Assay (EAA(TM)), the only FDA cleared diagnostic for the measurement of endotoxin. The conclusion of final commercial agreements is subject only to the completion of due diligence by Spectral and the determination of an approved clinical development pathway with the U.S. FDA.
"Toraymyxin(TM) is marketed in Japan and Europe and has been used to treat more than 50,000 sepsis patients safely and effectively. Spectral's EAA (TM) can identify patients that will benefit from Toraymyxin(TM) and monitor the effects of the treatment," said Dr. Paul Walker, President and CEO of Spectral. "This combination of the EAA(TM) diagnostic and the Toraymyxin(TM) therapeutic has been utilized by clinicians in Europe since November 2007 and has demonstrated the potential to lead to a significant reduction in mortality, as documented in the findings presented at the 28th International Symposium on Intensive Care and Emergency Medicine in March 2008. We believe that this combined treatment can fulfill a major unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year."
"The business alliance with Toray and the specific combination of our
approved diagnostic with their therapeutic device represent a significant
market opportunity for Spectral," said Anthony Businskas, Spectral's
Executive Vice-President and CFO. "Over the coming months, we expect to
complete our due diligence and discuss t
|SOURCE Spectral Diagnostics Inc.|
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