Orphan Drug Designation Could Serve Unmet Medical Need and Provide Significant Financial Benefits LONDON, ONTARIO--(Marketwired - April 4, 2014) - Critical Outcome Technologies Inc. ("COTI" or the "Company") (TSX VENTURE:COT), the bioinformatics and accelerated drug discovery company, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for its lead cancer drug candidate, COTI-2, for the treatment of ovarian cancer.
"We believe that COTI-2, with its p53 dependent mechanism of action, represents a significant therapeutic advantage over treatments currently available for ovarian and other gynecological cancers," said Dr. Wayne Danter, President and CEO. "The fact that more than 95% of ovarian cancers have a p53 gene mutation, combined with the extent of the unmet medical need in ovarian cancer patients, makes a treatment for this indication one of our top priorities. If COTI-2 is granted Orphan Drug status, the financial benefits in the future could be substantial and COTI-2 would be directed down a unique development pathway within the FDA, including the possibility of an expedited regulatory process and the potential for fewer patients to be required in clinical trials."
The Orphan Drug Designation may qualify the Company for several benefits under the U.S. Orphan Drug Act of 1983 (ODA), as amended. These benefits may include a seven-year period of orphan drug exclusivity upon product approval, fee reductions, assistance in study design from the FDA, potential for expedited drug development and eligibility for drug grants.
About Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant the Orphan Drug Designation to facilitate drug development for drugs that target conditions affecting fewer than 200,000 patients in the United States each year, while providing a significant therapeutic advantage over existing therapies. The first new drug application to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication.
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