22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco
harm reduction R&D and product development, today announced
David Sweanor, Adjunct Professor of Law, University of Ottawa, will
present the keynote address at 22nd Century Group’s annual
shareholder meeting on Saturday, April 25, 2015. The annual meeting
will be open to shareholders of record at the close of business on
February 26, 2015.
Professor Sweanor has spearheaded the development of
world-leading tobacco control initiatives in Canada since the
1980s, first as counsel to the Non-Smokers Rights Association and
then as an independent consultant. For many years he has studied
less hazardous alternatives to existing tobacco and nicotine
products. A pragmatic public health advocate, Professor Sweanor
recognizes both that there will be considerable use of nicotine
well into the future and that there is a pronounced spectrum of
risk associated with nicotine intake depending upon the delivery
system. Since many alternative nicotine products have comparatively
minor risks, risk reduction principles have enormous potential to
reduce tremendously the current global epidemic of smoking-caused
death and disease.
Professor Sweanor has been widely published in peer-reviewed
scientific journals as well as having authored work for major
national and international health and social service organizations.
He has received various awards for his work, including a ‘Public
Health Hero’ lifetime achievement award from the Pan-American
Health Organization.
Separately, to provide the general public with an overview of
22nd Century Group’s extraordinary intellectual property portfolio,
applications of the Company’s technology, and business priorities
going forward, the Company has released the following letter that
was included as part of its Annual Report to Shareholders:
Dear Fellow Shareholders:
As expected, 2014 represented a period of transition for 22nd
Century Group. From our inception, the Company focused primarily on
research and development. Since the latter part of last year,
however, we recast our priorities to instead concentrate our
efforts on monetizing our exceptional intellectual property
portfolio.
Coinciding with this change, in March 2015, our Board of
Directors appointed me Chief Executive Officer. I am honored and
tremendously excited to have been chosen to lead the Company at
this momentous time in our history.
Our technology is extraordinary. Our management team is
exceptional. Our mission is noteworthy. Indeed, in my new position,
I have reemphasized our core mission: to reduce the harm caused by
smoking. In pursuit of this important goal, we intend to help
millions of consumers who will use our products… and, at the same
time, provide substantial value to our shareholders.
22nd Century is in the rare position of having a virtual
monopoly around the nicotine biosynthetic pathway in the tobacco
plant. To capitalize on this extraordinary asset we have
articulated the Company’s most important priorities as follows:
1) Pursuit of FDA authorization for our BRAND A modified risk
cigarettes in development;
2) Contracting with a suitable joint venture partner to fund and
conduct a Phase III clinical trial for X-22, the Company’s
tobacco-based smoking cessation aid in development;
3) Obtaining substantial, multi-year sales contracts in Asia for
our proprietary tobacco products;
4) Commercialization of RED SUN® super-premium cigarettes in the
U.S.;
5) Launching MAGIC® very low nicotine cigarettes in Europe,
starting with Spain in the latter part of March 2015; and
6) Establishing a base of third-party contract manufacturing
business at our NASCO manufacturing facility.
The Company’s very low nicotine BRAND A modified risk candidate
is exactly consistent with what public health officials have long
sought:
“The FDA should quickly move to reduce nicotine levels in
cigarettes to non-addictive level. If we reduce the level of the
stimulus, we reduce the craving. It is the ultimate harm reduction
strategy.”
Dr. David Kessler, Former FDA CommissionerJune
16, 2010
There could be no stronger endorsement – from a more influential
public health official – than Dr. Kessler’s definition of “the
ultimate harm reduction strategy.” As the only company in the
world capable of producing tobacco cigarettes – without extraction
– with 95% less nicotine than conventional cigarettes, 22nd Century
is in the unique position of being able to achieve precisely what
Dr. Kessler envisions. To this end, we look forward to submitting
our application to the FDA later this year for our very low
nicotine BRAND A modified risk cigarettes in development.
Also utilizing our proprietary very low nicotine (VLN) tobacco,
our X-22 smoking cessation aid in development is another strategic
imperative for the Company. We hope to announce a joint venture
partner later this year to fund our Phase III clinical trial and to
help us commercialize X-22. There is good reason for us to be
enthusiastic about X-22: There have been five independent Phase II
clinical trials – and one independent Phase III clinical trial –
that have utilized cigarettes made from 22nd Century’s proprietary
tobacco (treating 2,438 total smokers); in
all 6 independent trials, VLN cigarettes increased quit
rates. Indeed, our VLN cigarettes are in a unique position
in that there is evidence in clinical studies demonstrating: (i)
VLN cigarettes work by themselves, (ii) VLN cigarettes increase the
efficacy of nicotine replacement therapy products (patch, gums and
lozenges), and (iii) VLN cigarettes increase the efficacy of
Pfizer’s Chantix®. The smoking cessation market is a multi-billion
dollar industry and securing even a small portion of that market
would be quite significant for our Company. To this end, the
approval of X-22 by the FDA would be monumental for our Company and
our shareholders.
We also intend to continue to pursue potential joint ventures
and other business opportunities in Asia. To further facilitate
22nd Century’s business opportunities in Asia, I will be making
additional trips to Asia in 2015. I am optimistic that we will be
able to announce one or more business contracts with Asian partners
in 2015.
An important step along 22nd Century’s path to commercialization
occurred when our Company became a subsequent participating member
of the U.S. tobacco Master Settlement Agreement (MSA). Through our
acquisition of NASCO Products, LLC, we were the first company in
more than six years to become a new signatory to the MSA. As a
result of this very important achievement, the Company began the
process of listing its super premium brand, RED SUN,® on the state
tobacco directories of approved products across the United States.
We have received approvals from 42 states already and we expect to
gain approval from the remaining states very soon.
Our Company also continues to move forward with efforts to
launch our MAGIC® brand of very low nicotine cigarettes in Europe
and Asia. Our Company’s contract cigarette manufacturer in Europe
has begun production of our MAGIC® brand for a product launch in
Spain planned for the latter part of March 2015. We have already
received preorders from several hundred stores in Spain, the MAGIC®
website is nearly complete, and we are increasingly excited about
the prospects of MAGIC® in Spain and in other parts of Europe.
Looking ahead, our prospects have never been better. We are
intensely focused on the business drivers which will make the
biggest differences for our Company and our shareholders. On behalf
of the 22nd Century Group management team, we thank you for being
part of our family of shareholders; we look forward to keeping you
apprised of our exciting commercialization achievements in the
months to come.
Best regards,
Henry Sicignano IIIChief Executive Officer, President and
Director
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants through genetic engineering and plant
breeding. The Company’s mission is to reduce the harm caused by
smoking. 22nd Century owns or exclusively controls 128 issued
patents plus an additional 52 pending patent applications; the
patents owned by us or exclusively licensed to us include patents
issued in 96 countries. The Company’s strong IP position led to a
licensing agreement with British American Tobacco (“BAT”), the
world’s second largest tobacco company. 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. 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, 2014, filed on February 5, 2015,
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.
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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