TORONTO, March 9 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. today announced that it has signed a license agreement with Toray Industries, Inc. of Japan granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream. Under the terms of the agreement, Spectral will seek FDA approval for Toraymyxin(TM) and intends to commercialize the product together with its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared diagnostic for the measurement of endotoxin.
“The finalization of this agreement, on schedule, is an important milestone for Spectral and demonstrates the significant progress we have made on our path to delivering an effective treatment for severe sepsis in the United States. Toraymyxin(TM) has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis caused by endotoxemia,” said Dr. Paul Walker, President and CEO of Spectral. “Furthermore, together with our proprietary EAA(TM), the combination has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care in European clinical trials. This innovative product has the potential to fulfill a severely unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year.”
Spectral plans to conduct a pre-Investigational Device Exemption (pre-IDE) meeting with the U.S. FDA this quarter as a first step towards gaining clearance for its clinical strategy, with the objective of initiating clinical trials in the latter half of 2009.
About Toray
Toray Industries, Inc. is a leading diversified chemicals corporate group that has been technology-focused since its foundation in 1926. The company’s operations are underpinned by technological expertise in organic synthetic chemistry, polymer chemistry, and biochemistry. These innovative technologies have yielded “advanced materials” that Toray is now exploiting to provide customers with comprehensive solutions through Fibers and Textiles, Plastics and Chemicals, IT-related Products, Carbon Fiber Composite Materials, Environment and Engineering, Life Science and Other Business divisions. In FY2008, Toray had consolidated sales of 1,650 billion yen (approx $15 billion US), and over 33,000 employees worldwide. For further information, please visit www.toray.co.jp.
About Spectral Diagnostics
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral’s lead product is its EAA(TM) Endotoxin Activity Assay, the only FDA approved diagnostic for the measurement of endotoxin. Spectral technologies provide accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Spectral is listed on TSX under the symbol SDI.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
CONTACT: Dr. Paul Walker, President & CEO, (416) 626-3233 ex. 2100; Casey
Gurfinkel, Investor Relations, (416) 815-0700 ext. 283,
cgurfinkel@equicomgroup.com
