|[June 11, 2014]
U.S. Patent Allowed For 22nd Century Group's Technology to Regulate Nicotine Levels in Tobacco
CLARENCE, N.Y. --(Business Wire)--
22nd Century Group, Inc. (NYSE MKT:XXII)
today announced that on June 9, 2014 the U.S. Patent and Trademark
Office (USPTO) issued a Notice of Allowance to the Company for
technology that reduces nicotine in tobacco by suppressing expression of
the NBB gene by itself and in combination with other nicotine
There are various commercial applications of the NBB technology,
including producing cigarettes with various nicotine levels, from very
low to high. The Company expects to use very low nicotine cigarettes
produced with the NBB technology for a modified risk application to be
filed with the U.S. Food and Drug Administration. Many studies have been
carried out with the Company's proprietary very low nicotine cigarettes.
A recently published independent clinical
trial (Vogel et al. 2014), concluded, "Very low nicotine content
(VLNC) cigarettes lead to a reduction in the number of cigarettes
smoked, toxicant exposure, withdrawal symptoms and dependence."
U.S. Patent Application Number 11/579,661, Reducing Levels of
Nicotinic Alkaloids in Plants, and related International Patent
Application PCT/IB2006/001741, cover methods for producing tobacco
plants with decreased nicotine levels and tobacco plants and products
produced therefrom. The patent will be granted by the USPTO shortly, and
upon grant the USPTO will convey to the Company a Patent Term
Adjustment, which is expected to extend the expiration date beyond
February 28, 2026.
The NBB gene encodes a protein, "nicotine synthase," that is involved in
the final step of nicotine biosynthesis. Having eluded scientists for
decades, this prtein can be down-regulated or up-regulated to produce
tobacco varieties with a wide range of nicotine levels. International
Patent Application PCT/IB2006/004043 covers methods for producing
tobacco plants with increased nicotine levels with the NBB technology
and tobacco plants and products produced therefrom. Patent applications
for the NBB technology have been filed by 22nd Century on a worldwide
basis and patents are currently issued to 22nd Century in China, Japan,
Taiwan, Mexico, Australia and South Africa. Patents will also soon be
granted to 22nd Century for the NBB technology in the United Kingdom,
Ireland, Germany, France, Italy, Spain, Poland, Switzerland and Turkey.
Dr. Takashi Hashimoto of the Nara Institute of Science and Technology
(NAIST), a world-renowned plant molecular biologist, is an inventor of
the NBB technology. 22nd Century funded research and development at
NAIST from 2005 to 2009, and in 2010 NAIST assigned various patent
families to 22nd Century, including the NBB patent families.
The Company's vice president of research and development, Dr. Michael
Moynihan stated, "The NBB gene technology is one of the keystones of
22nd Century's intellectual property and represents our
second-generation gene technology that has significant advantages over
our earlier technology." Specifically, the sole function of NBB is to
produce nicotine and other nicotinic alkaloids.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company whose proprietary
technology allows for the levels of nicotine and other nicotinic
alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco
plant to be decreased or increased through genetic engineering and plant
breeding. 22nd Century owns or is the exclusive licensee of 116 issued
patents in 78 countries plus an additional 42 pending patent
applications. Goodrich Tobacco Company, LLC and Hercules
Pharmaceuticals, LLC are wholly-owned subsidiaries of 22nd Century.
Goodrich Tobacco is focused on commercial tobacco products and
potentially less harmful cigarettes. 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.
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