Overwhelming Physician and Consumer Support Cited for 22nd Century’s “X-22” Very Low Nicotine Smoking Cessation Product
September 27 2016 - 9:55AM
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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Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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