Spectral to bring anti-sepsis therapy to the U.S. market

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[{"type":"text","content":"\n\n\n\nTORONTO, Sept. 23 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) today\nannounced that it has agreed to key terms with Toray Industries Inc. of Japan\nto obtain the exclusive development and commercial rights in the U.S. for\nToraymyxin(TM), a therapeutic for the treatment of sepsis that removes\nendotoxin from the bloodstream. Under the terms of the agreement, the Company\nwill seek FDA approval for a combined product for the treatment of severe\nsepsis that will include Toraymyxin(TM) and Spectral's Endotoxin Activity\nAssay (EAA(TM)), the only FDA cleared diagnostic for the measurement of\nendotoxin. The conclusion of final commercial agreements is subject only to\nthe completion of due diligence by Spectral and the determination of an\napproved clinical development pathway with the U.S. FDA.\n\n\n"Toraymyxin(TM) is marketed in Japan and Europe and has been used to\ntreat more than 50,000 sepsis patients safely and effectively. Spectral's\nEAA (TM) can identify patients that will benefit from Toraymyxin(TM) and\nmonitor the effects of the treatment," said Dr. Paul Walker, President and CEO\nof Spectral. "This combination of the EAA(TM) diagnostic and the\nToraymyxin(TM) therapeutic has been utilized by clinicians in Europe since\nNovember 2007 and has demonstrated the potential to lead to a significant\nreduction in mortality, as documented in the findings presented at the 28th\nInternational Symposium on Intensive Care and Emergency Medicine in March\n2008. We believe that this combined treatment can fulfill a major unmet need\nfor the approximately 100,000 patients that develop severe sepsis or septic\nshock in the U.S. each year."\n\n\n"The business alliance with Toray and the specific combination of our\napproved diagnostic with their therapeutic device represent a significant\nmarket opportunity for Spectral," said Anthony Businskas, Spectral's Executive\nVice-President and CFO. "Over the coming months, we expect to complete our due\ndiligence and discuss the clinical development pathway for this combined\nproduct with the U.S. FDA. Finalization of the exclusive license and material\nsupply agreements with Toray is anticipated to occur in the first quarter of\n2009."\n\n\nAbout Toray\n\n\nToray Industries, Inc. is a leading diversified chemicals corporate group\nthat has been...

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