RYE, N.Y., Feb. 3, 2014 — Curemark, a drug research and development company focused on neurological disorders, announced that the company has been awarded 6 new patents for its enzyme delivery system. The new patents, issued in Europe, Australia and Central America, extend to 2030 and can be utilized for multiple enzyme products including CM-AT, Curemark’s proprietary autism drug.
“We are thrilled to receive these patents,” stated Dr. Joan Fallon, Curemark founder and CEO. “They are a major step forward toward bringing our platform technology to children and adults around the world who need it.”
Curemark previously announced that it has begun the rolling submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for CM-AT.
The FDA has granted CM-AT the agency’s Fast Track designation. The Fast Track designation is provided to investigational new drugs that are intended to treat serious or life-threatening conditions and that have demonstrated the potential to meet unmet medical needs. The FDA works closely with manufacturers to develop Fast Track designated products which allows for rolling pre-submission and seeks to expedite the review of these drugs.
Curemark is a drug research and development company focused on the treatment of neurological and other diseases, especially those with dysautonomic components, by addressing certain key gastrointestinal/pancreatic secretory deficiencies. The company previously announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. To learn more about the company’s innovative science, visit www.curemark.com
This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of the Curemark products CM-AT, CM-4612 and CM-182 their potential advantages, their potential for use in treating diseases or disorders, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning the Curemark products CM-AT, CM-4612 and CM-182. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the Curemark products CM-AT, CM-4612 and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182 regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.