22nd Century Group Granted Meeting with FDA to Advance Development of a Potential Modified Risk Cigarette
September 25 2014 - 7:22AM
Business Wire
22nd Century Group, Inc. (NYSE MKT:XXII) announced today that
the Center for Tobacco Products (“CTP”) of the U.S. Food and Drug
Administration (“FDA”) has granted the Company a meeting on
November 12, 2014 to discuss the further development of the
Company’s potential modified risk tobacco product, code-named BRAND
B (“BB-1”), which is a cigarette that is designed to provide an
exceptionally low tar-to-nicotine yield ratio. As compared to other
commercial low-yield cigarettes, the only differentiating factor of
the BB-1 cigarette is that 22nd Century’s proprietary high-nicotine
tobacco is used, which tobacco is planted, grown, harvested, cured,
and processed in exactly the same manner as conventional commercial
tobacco.
Pursuant to the Family Smoking Prevention and Tobacco Control
Act of 2009 (“Tobacco Control Act”), the Company intends to
demonstrate, through BB-1 exposure studies, compelling scientific
evidence that 22nd Century’s cigarettes (i) reduce exposure to
tobacco toxins and (ii) are reasonably likely to result in a
measurable and substantial reduction in morbidity or mortality
among individual tobacco users. The purpose of the Company’s
meeting with CTP will be to seek the Agency’s concurrence that 22nd
Century’s proposed BB-1 clinical study is adequate to support the
development of BB-1 as a potential modified risk tobacco
product.
22nd Century believes that BB-1 will allow smokers to obtain a
satisfactory amount of nicotine per cigarette while inhaling less
smoke, including “tar” and carbon monoxide. Commercial cigarette
brands average a tar-to-nicotine ratio of approximately 13 to 1,
meaning that the smoker must inhale 13 parts “tar” for every 1 part
nicotine. The tar-to-nicotine ratio of BB-1 is approximately 6 to
1.
By utilizing a combination of 22nd Century’s proprietary
high-nicotine content tobacco and a special low-yield cigarette
design, BB-1 has the nicotine yield of a commercial full flavor
cigarette, but the “tar” yield of an “ultra-light” commercial
cigarette. Consequently, the Company expects that BB-1 cigarettes
will curtail the compensatory smoking behaviors (such as taking
bigger puffs and more puffs per cigarette) associated with what
were formerly known in the United States as “light” and
“ultra-light” cigarettes due to diluted nicotine amounts in the
smoke, as compared to their full flavor (high yield) counterparts.
The Tobacco Control Act banned the use of “light,” “ultra-light”
and similar descriptors on the labeling and advertising of
cigarettes since these types of cigarettes generally do not reduce
smoke exposure.
Joseph Pandolfino, Founder and CEO of 22nd Century Group,
explained, “BB-1 is designed to deliver a conventional amount of
nicotine to smokers – with substantially less smoke. We look
forward to working with the FDA during the development of this
exciting product.” With FDA concurrence, 22nd Century will conduct
an exposure study on BB-1 in the first quarter of 2015.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company whose proprietary
technology through genetic engineering and plant breeding allows
(i) the level of nicotine (and other nicotinic alkaloids) in the
tobacco plant to be decreased or increased and (ii) the levels of
cannabinoids in the cannabis plant to be decreased or increased, in
addition to the cannabinoid profile being tailored. 22nd Century
owns or is the exclusive licensee of 129 issued patents in 78
countries plus an additional 51 pending patent applications, and
22nd Century has co-exclusive rights to another 16 patent
applications. Goodrich Tobacco is focused on commercial tobacco
products and potentially less harmful cigarettes. Botanical
Genetics is focused on natural cannabis-based products for human
health, well-being and nutrition, in addition to industrial
products refined from cannabis. Hercules Pharmaceuticals is focused
on X-22, a prescription smoking cessation aid in development.
For additional information, please visit:
www.xxiicentury.com
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. 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, 2013, filed on January 30, 2014,
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.
Redington, Inc.Tom Redington, 203-222-7399
22nd Century (AMEX:XXII)
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