22nd Century Granted FDA Guidance Meeting for X-22 Smoking Cessation Aid
02 March 2017 - 10:59PM
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170302005015/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.com
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