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

CLARENCE, N.Y.–(BUSINESS WIRE)– 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.

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