Orphan Drug Designation Could Serve Unmet Medical Need and Provide Significant Financial Benefits
April 4, 2014
Critical Outcome Technologies Inc., the bioinformatics and accelerated drug discovery company, announced 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.
About Critical Outcome Technologies Inc.
COTI is a leading-edge technology company specializing in accelerating the discovery and development of small molecules – dramatically reducing the time and cost to bring new drugs to market. COTI’s proprietary artificial intelligence system, CHEMSAS®, utilizes a series of predictive computer models to identify compounds with a high probability of being successfully developed from disease specific drug discovery through chemical optimization and preclinical testing. These compounds are targeted for a variety of diseases, particularly those for which current treatments are either lacking or ineffective.
For more information, visit www.criticaloutcome.com.
Follow @CriticalOutcome on Twitter at http://twitter.com/CriticalOutcome.