CLARENCE, N.Y.--(BUSINESS WIRE)--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.
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.