FDA Provides Positive and Encouraging Feedback for 22nd Century’s Very Low Nicotine MRTPA Filings
January 05 2017 - 9:15AM
Business Wire
22nd Century Seeking Approval to Market the
World’s Lowest Nicotine Tobacco Cigarettes
22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology
company that is focused on reducing the harm caused by smoking,
today announced that the U.S. Food and Drug Administration (FDA)
has provided the Company with helpful and positive feedback on the
Company’s combined Modified Risk Tobacco Product Applications
(MRTPAs) and Premarket Tobacco Product Applications (PMTAs) for
22nd Century’s “BRAND A” Very Low Nicotine tobacco cigarettes.
On December 31, 2015, the Company’s wholly owned subsidiary,
Goodrich Tobacco Company, submitted MRTPAs and PMTAs to the FDA
seeking a reduced exposure order for 22nd Century’s “BRAND A” Very
Low Nicotine cigarettes. More specifically, the Company requested
in its MRTPAs permission from the FDA to be able to state, as
truthful and accurate in BRAND A packaging and marketing, that the
Company’s proprietary Very Low Nicotine cigarettes reduce smokers’
exposure to nicotine.
With less than 0.6 mg nicotine per cigarette and less than 0.05
mg nicotine yield per cigarette, BRAND A cigarettes are the world’s
lowest nicotine tobacco cigarettes. Relative to “Big Tobacco”
cigarette brands, including Marlboro®, Camel®, Newport®, and
American Spirit®, BRAND A contains 95% less nicotine. Unlike
so-called “light” or “ultra-light” cigarettes (which terms are now
banned by the FDA from labeling and marketing in the United
States), 22nd Century’s proprietary BRAND A cigarettes are designed
to deliver greatly reduced ratios of nicotine to other smoke
components.
The Company is very pleased with the productive and encouraging
communication it received from the FDA. Though the Company is only
requesting an MRTP marketing order that will allow 22nd Century to
disclose that BRAND A reduces smokers’ exposure to nicotine, the
FDA has requested more information related to the independent
clinical studies on the Company’s Very Low Nicotine tobacco that
focused on smoking cessation and harm reduction objectives.
Further, though the Company’s MRTPAs and PMTAs for BRAND A
included a comprehensive overview of many independent clinical
trials that have found that smoking 22nd Century’s Very Low
Nicotine cigarettes delivers the sensory and behavioral experience
associated with conventional cigarettes while providing only
minimal exposure to the most addictive component of tobacco, the
FDA expressed interest in receiving additional documents pertaining
to research findings and statistical analyses related to the focus
group studies that were conducted in support of the Company’s BRAND
A applications.
In response to the FDA’s requests, and in conjunction with
additional clarifying guidance, the Company has withdrawn its
existing filings in order to file even more expansive and robust
MRTPAs and PMTAs for BRAND A that will include additional
scientific data and information from already completed clinical
studies on the Company’s Very Low Nicotine tobacco cigarettes, in
addition to smoking cessation research. In order to help further
expedite the FDA review process, the Company also intends to
bifurcate its application into separate PMTAs and MRTPAs for BRAND
A to enjoy the benefit of the FDA’s shorter review timing for PMTAs
as compared to MRTPAs.
As 22nd Century expands upon its discussion and interactions
with the FDA’s Center for Tobacco Products (CTP) on the Company’s
MRTPAs and PMTAs for its BRAND A Very Low Nicotine over-the-counter
product, the Company is also continuing to separately work with the
FDA’s Center for Drug Evaluation and Research (CDER) with respect
to the Company’s previously-filed New Drug Application (NDA) for
22nd Century’s proposed “X-22” prescription-based smoking cessation
product. Thus, 22nd Century is advancing two distinct products –
one a proposed reduced exposure combustible cigarette, the other a
proposed pharmaceutical smoking cessation aid – with different
parts of the FDA.
“The World Health Organization has recommended ‘mandated
reductions in nicotine to minimally addictive levels.’
Unfortunately, at present, smokers in the United States do not have
a Very Low Nicotine cigarette option,” explained Henry Sicignano,
III, President and Chief Executive Officer of 22nd Century Group.
“To address this critically important issue, we look forward to
collaborating with the FDA in 2017 on both BRAND A and on X-22 in
order to provide consumers access to 22nd Century’s remarkable Very
Low Nicotine products.”
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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Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
22nd Century (AMEX:XXII)
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