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 Commissioner
June 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 III
Chief 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.
Copyright Business Wire 2015