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.
Copyright Business Wire 2014