22nd Century Granted FDA Guidance Meeting for X-22 Smoking Cessation Aid
CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is focused on reducing the harm caused by smoking, announced today that the Company has been granted a guidance meeting with the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) to discuss “X-22,” which the Company is developing as its signature smoking cessation aid. At the meeting, which will take place this June, the Company will seek agreement from CDER/FDA on an appropriate path for X-22 to become a prescription-based cessation aid for smokers in the United States.
The Company’s keystone technology is its ability to grow proprietary Very Low Nicotine tobacco that contains up to 95% less nicotine than conventional tobacco plants. Independent clinical studies have shown that 22nd Century’s Very Low Nicotine SPECTRUM® cigarettes sever the powerful connection between the act of smoking and the rapid delivery of nicotine to the body. 22nd Century believes that X-22 may ultimately prove to be the most effective tool in the fight against nicotine addiction.
FDA approval must be obtained before a product can be marketed for smoking cessation. The Tobacco Control Act provides that, at the request of an applicant, the FDA shall consider designating products for smoking cessation as “fast track” research. The FDA’s “fast track” program is intended to facilitate development and to expedite review of drugs that, among other things, treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. 22nd Century intends to seek “fast track” designation by the FDA for X-22.
“We are looking forward to meeting with FDA’s CDER this June to discuss development of our X-22 smoking cessation aid,” explained Henry Sicignano, III, President and CEO of 22nd Century Group. “Given that 89% of smokers that we have surveyed report that X-22 would be their top or first choice to help them quit smoking, we believe that doctors and patients across the United States should have the choice of being able to utilize X-22 in their fight against nicotine addiction.”
Mr. Sicignano continued, “Independent scientific researchers have indicated that cigarettes made from 22nd Century’s proprietary Very Low Nicotine tobacco could save millions of lives and billions of dollars in healthcare costs. We think the time for X-22 smoking cessation cigarettes has arrived.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
Andrew Haag, 866-976-4784
Source: 22nd Century Group, Inc.
Released March 2, 2017