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Press Release

Overwhelming Physician and Consumer Support Cited for 22nd Century’s “X-22” Very Low Nicotine Smoking Cessation Product

22nd Century Group,Inc.
Posted on: 27 Sep 16

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced results from two separate independent surveys showing that strong consumer demand mirrors physicians’ willingness to prescribe the Company’s X-22 smoking cessation aid in development.

X-22 is a Very Low Nicotine tobacco-based botanical medical product for smoking cessation. Independent clinical studies have demonstrated that combustible cigarettes containing 22nd Century’s Very Low Nicotine tobacco with non-addictive levels of nicotine enable smokers to disassociate the act of smoking from the rapid intake of nicotine. X-22 involves the same smoking behavior as conventional cigarettes and does not expose the smoker to any new drugs or new side effects. 22nd Century has an active Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) relating to the X-22 smoking cessation product.

To assess consumer reaction to X-22, the first survey, conducted by Survata, an independent market research firm based in San Francisco, California, questioned 501 current smokers in the United States, who have tried to quit at least once, about their failed quit attempts. Participants were then given a brief overview of 22nd Century’s X-22 Very Low Nicotine cigarettes designed for use as a prescription smoking cessation aid. Overall, the vast majority of smokers expressed strong enthusiasm for 22nd Century’s X-22 product to become available at U.S. pharmacies. Indeed, of the 501 smokers surveyed, if X-22 were currently available:

  • 89% said X-22 would be their top or first choice to help them quit smoking.
  • 88% indicated that they would have attempted to quit smoking sooner if X-22 had been available when they first considered quitting.
  • 85% would pursue a prescription for X-22 from their doctor to help them quit smoking.

22nd Century also commissioned surveys (conducted by Survata and by Dobrin Consulting in Richmond, Virginia) of 136 practicing physicians who have experience in helping patients quit smoking. Physicians reviewed detailed information regarding the use and efficacy of X-22, including published results from several of the numerous independent clinical trials that have been conducted with cigarettes made with 22nd Century’s proprietary Very Low Nicotine tobacco. Most importantly, of the 136 physicians surveyed:

  • 89% said that they would prescribe X-22 cigarettes to help their patients quit smoking.
  • 75% selected the descriptive phrase: “addresses the behavioral aspects of smoking” as the most appealing aspect of X-22.
  • 70% listed “reduces cravings” as a highly appealing feature of X-22.
  • More than 50% mentioned “no new side effects” among the most compelling reasons to recommend X-22 to their patients.

“When you have hard data asserting that 89% of physicians will prescribe your product – paired with rapidly growing support in the scientific community – I think we conclusively put to rest any questions about the potential for X-22 as a blockbuster smoking cessation drug,” explained James Vail, Director of Business Development at 22nd Century Group.

Mr. Vail will share more detailed consumer and physician survey results October 5-7 at BioNetwork’s Partnering Summit in Laguna Niguel, California. BioNetwork’s annual event brings together the decision-makers and business development executives from the pharmaceutical and biotechnology industries to initiate strategic partnerships. Mr. Vail will also share an overview of the now 15 completed and 19 on-going independent clinical research studies using the Company’s Very Low Nicotine tobacco. Since 2015, the number of published studies using 22nd Century’s proprietary Very Low Nicotine tobacco has more than doubled. The results of these studies have been overwhelmingly favorable. Of notable importance, an independent clinical study, funded in part by the FDA, and published in the October 2015 issue of The New England Journal of Medicine, found that smokers of 22nd Century’s VLN cigarettes consumed far fewer cigarettes per day and doubled their quit attempts versus smokers of conventional cigarettes.

“Given the opportunity, a vast majority of informed physicians report that they will prescribe X-22 to patients who wish to quit,” explained Henry Sicignano, III, President and CEO of 22nd Century Group. “Considering this enthusiasm, in conjunction with the fact that nearly 90% of surveyed smokers indicate that they are eager to try X-22, we have all of the ingredients for a tremendous commercial success… indeed, a success that will save millions of lives and billions of dollars in healthcare costs.”

Phase II and Phase III clinical results collected by scientific researchers around the world have demonstrated the safety and efficacy of 22nd Century’s proprietary Very Low Nicotine tobacco cigarettes. Independent clinical trials utilizing 22nd Century’s Very Low Nicotine cigarettes to treat more than 4,000 total smokers have shown increased quit rates, whether the Very Low Nicotine cigarettes were used alone; used concurrently with nicotine replacement therapies, such as nicotine gums, nicotine patches, and nicotine lozenges; or used concurrently with Pfizer’s Chantix®. A summary of 34 independent clinical research studies and 10 scientific opinion pieces related to 22nd Century’s Very Low Nicotine tobacco are available on the Company’s Heracles Pharmaceuticals’ website at: http://heraclespharma.com/clinical-trials-2/

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 and www.heraclespharma.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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160927006074/en/

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Last updated on: 27/09/2016

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