RE: XXII from streamingeagle88 - admin - 02-22-2015
You may like technology (who doesn't these days) or the energy sector (where would we be without it) -- but if you're making a long-term bet as an investor, there's a lot going for Big Tobacco. It's not just that tobacco boasts the best historical performance of all U.S. industries. The industry's future seems especially bright. As marijuana gradually becomes a legal drug, Big Tobacco is poised to dominate the market.
Big Tobacco's Future: Big Pot - Bloomberg View
RE: XXII from streamingeagle88 - admin - 04-16-2015
22nd Century Group Announces Launch of “0.0 mg Nicotine” MAGIC Cigarettes in Spain
22nd Century Group, Inc. (NYSE MKT:XXII) today announced that on April 21, 2015 in Valencia, Spain at the SH Valencia Palace hotel, the Company will hold a press conference announcing the launch of MAGIC cigarettes in approximately 900 state-licensed retail shops across Spain. MAGIC cigarettes will be available to consumers starting April 24, 2015.
22nd Century’s MAGIC cigarettes are made with the Company’s proprietary very low nicotine tobacco and are manufactured for sale in Europe by Orion Tobacco Corporation. Designed to appeal to discriminating consumers and positioned to compete with premium cigarette brands, MAGIC 0 yields only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands. Indeed, MAGIC 0 is the world’s only virtually nicotine-free tobacco cigarette. MAGIC 2 yields 0.2 mg nicotine per cigarette – an 80% reduction in nicotine as compared to conventional brands.
In accordance with European regulations which require cigarette manufacturers to list the nicotine yield directly on each pack of cigarettes and to round the yield to the nearest 1/10 place, MAGIC 0 packs prominently feature the words: “0.0 mg nicotine.” MAGIC 2 packs read “0.2 mg nicotine.” Dr. Michael Moynihan, VP of Research and Development at 22nd Century remarked: “We are very proud of our technology which allows us to grow the world’s lowest nicotine tobacco. This technology is what makes our extraordinary MAGIC 0 cigarettes possible.”
Aldista 2000, the distributor for MAGIC cigarettes across Spain, has taken pre-orders for MAGIC cigarettes at more than 900 stores and expects to place MAGIC in 2,500 retail stores – approximately 18% of the retail cigarette stores in Spain – by the end of this summer.
Mr. Miguel Molina of Trexper who serves 4,500 retail locations in Spain explained, “Since I learned that MAGIC was coming to Spain, I knew I wanted to sell these nicotine-free cigarettes in my stores. I am confident MAGIC 0 cigarettes will be very well received by consumers who want to be free of their addiction to nicotine.”
"Using proprietary, real tobacco grown in the United States – without any artificial extraction or chemical processes – 22nd Century is the only company in the world that can make '0.0 mg nicotine' cigarettes," explained Henry Sicignano III, President and Chief Executive Officer. "Launching in Spain is an important first step for us... Later this year, we intend to expand distribution of MAGIC cigarettes to other parts of Europe."
RE: XXII from streamingeagle88 - admin - 04-21-2015
Bloomberg Intelligence identified 55 public companies whose business is based largely or completely on legal marijuana, and whose shares traded at $0.10 or more as of April 15th. These wildly fluctuating penny stocks aren’t for the faint of heart.
For These 55 Marijuana Companies, Every Day is 4/20
The link contains some cool graphs..
RE: XXII from streamingeagle88 - admin - 04-21-2015
The pot holiday '4/20' is a major sales boost for marijuana vendors similar to the way St. Patrick's Day lifts beer sales, said Christian Hageseth, founder of Green Man Cannabis and author of 'Big Weed.' Hageseth added that he tripled sales of marijuana this past weekend and won the 'Cannabis Cup' for the fourth year in a row. He said inefficient markets still make it possible for entrepreneurs to enter the marijuana business. In the long term, however, Hageseth said he expects big pharma and big tobacco to gain a huge share of the market, as well as a large consolidated company similar to the way Starbucks is the dominant coffee chain. Still, he said there will be room for small individual operators in the same vein as independent booksellers.
Expect Big Tobacco, Big Pharma to Eventually Cash in on 'Big Weed' - Video - TheStreet
RE: XXII from streamingeagle88 - admin - 04-28-2015
April 27, 2015 5:01 PM
Segment Covers the Launch of MAGIC 0.0 mg Nicotine Cigarettes in Europe
CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT:XXII), a leader in very low nicotine tobacco technology and tobacco harm reduction, today announced that Stuart Varney of Fox Business’ “Varney & Co” will conduct a live interview with 22nd Century’s President and Chief Executive Officer, Henry Sicignano III, on Tuesday, April 28, 2015 at 12:50 pm EST. Mr. Sicignano will discuss the Company’s successful launch in Europe of MAGIC 0, its 0.0 mg nicotine cigarette, in addition to the Company’s important patent portfolio and its rapidly growing distribution network for RED SUN, the Company’s super-premium cigarette brand available in the United States.
MAGIC 0 cigarettes are the world’s only 0.0 mg nicotine tobacco cigarettes. This extraordinary new product is currently available to consumers at approximately 900 state-licensed tobacco retailers in Spain and will soon be launched in several other European countries. Designed to appeal to discriminating consumers and positioned to compete with premium cigarette brands, MAGIC 0 yields only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands – which, pursuant to European Union regulations, is rounded to the nearest one-tenth, thereby resulting in MAGIC 0 tobacco cigarettes being labeled as having 0.0 mg nicotine per cigarette.
Professor David Sweanor, Adjunct Professor of Law at the University of Ottawa and a leading public health advocate, explained on this past Saturday, April 25th, in his keynote address at the Company’s annual shareholder meeting that 22nd Century enjoys the almost unprecedented opportunity “to do well for the Company and its shareholders… by doing good for smokers” by breaking the connection between smoking and the delivery of nicotine through its proprietary very low nicotine tobacco.
22nd Century Group boasts a very strong intellectual property portfolio and is focused on technology that allows the Company to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. Annual worldwide tobacco product sales, mostly of cigarettes, are approximately $800 billion. The smoking cessation market is estimated at $1 billion in the U.S. and $3+ billion globally and is forecast to grow to approximately $5 billion by 2020. With the corporate mission of “reducing the harm caused by smoking,” 22nd Century Group has a long-term focus on licensing, manufacturing and selling its very unique and proprietary tobacco and innovative cigarettes.
Varney & Co. with Stuart Varney programming details are as follows:
Date: Tuesday, April 28, 2015
Start Time: 12:50 pm EST
Live TV: Fox Business Network
RE: XXII from streamingeagle88 - admin - 04-28-2015
22nd Century Group (NYSE: XXII) held its annual meeting of shareholders on Saturday, April 25, 2015, at the historic Buffalo Club in downtown Buffalo. Henry Sicignano III, President and CEO, addressed the following topics:April 28, 2015 9:00 AM EDT
Modified Risk/FDA:
The Company intends to submit an application for its very low nicotine cigarette (Brand A) to the FDA this summer. Gaining Modified Risk approval for the Company’s low tar-to-nicotine ratio cigarette (Brand B) is also a priority. However, since applying for Brand B Modified Risk approval will require a substantially greater investment in time and money, the Company plans to submit a Brand B application in 2016.
X-22:
The Company recently completed visits to Japan and Europe where management met with potential joint venture partners for X-22, the Company’s smoking cessation aid in development.
RED SUN:
In the first three months on the U.S. market, the Company secured distribution for RED SUN premium cigarettes in approximately 200-300 retail stores in more than 40 states. Management expects to announce the signing of additional distributors and regional retail store groups in the coming months.
MAGIC:
The Company recently launched its 0.0 mg MAGIC 0 cigarettes in Europe. The Company is marketing two styles of MAGIC cigarettes: MAGIC 0 with 95% less nicotine than conventional brands and MAGIC 2 which features an 80% reduction in nicotine. MAGIC cigarettes are currently available in approximately 900 state-licensed tobacco stores in Spain. The store count is expected to top 2,500 in Spain by the end of 2015. Further, the Company expects distribution of MAGIC cigarettes to reach several additional European countries in the next several months.
China:
It remains an important priority for the Company to introduce 22nd Century’s proprietary tobacco to China. Despite significant regulatory hurdles, the Company continues to make progress in this effort.
Contract Manufacturing:
NASCO Products LLC, the Company’s cigarette manufacturing subsidiary located in Mocksville, North Carolina, continues to produce Smoker Friendly, Cigar Cartel, and other private label brands in addition to 22nd Century’s proprietary brands.
Increased Investor Relations Outreach:
Given the exciting opportunities and events underway at the Company, management expects to increase its investor relations activities in the coming months. Mr. Sicignano is scheduled to attend several investor conferences, including the upcoming Marcum Conference in New York City in late May and the LD Micro conference in Los Angeles in June, and will conduct non-deal investor road shows in select regions during the balance of 2015. Mr. Sicignano is also looking forward to media opportunities, such as his upcoming interview today on Fox Business’ Stuart Varney show.
Mr. Sicignano noted, “We are very pleased to report to our shareholders the substantial progress underway at 22nd Century Group. It is an exciting time for all of us; the market response to RED SUN and MAGIC has been tremendous. We look forward to developing these exciting new brands.”
FORMAL MATTERS DETERMINED BY SHAREHOLDER VOTE:
Proposal 1 Passed: Both Henry Sicignano III, who is also currently the CEO and President, and Richard M. Sanders were re-elected as Class I Directors with terms expiring in 2018.
Proposal 2 Passed: The Advisory Resolution on Executive Compensation was approved.
Proposal 3 Passed: Freed Maxick CPAs, PC was ratified as the Company’s independent registered certified public accounting firm for 2015.
RE: XXII from streamingeagle88 - admin - 05-13-2015
22nd Century Group, Inc.May 11, 2015 6:47 PM
CLARENCE, N.Y.--(BUSINESS WIRE)--
22nd Century Group, Inc. (NYSE MKT:XXII) announced today that the Company filed its first quarter 2015 report on Form 10-Q with the U.S. Securities and Exchange Commission and will provide a business update for investors on a conference call to be held Tuesday, May 12th at 10:00 AM (EDT).
Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group, together with John T. Brodfuehrer, Chief Financial Officer, will conduct the call. Interested parties are invited to participate in the call by dialing: 877-852-6583 and using Conference ID 7352193.
The conference call will consist of an overview summary of the financials presented in the Company's first quarter 2015 Form 10-Q and a discussion of business highlights and updates. Immediately thereafter, there will be a question and answer segment open to all callers.
As expected, revenues during the first quarter of 2015 were strong. While not currently at full production capacity, in the first quarter 2015 the Company’s factory began contract manufacturing a third-party MSA cigarette brand, continued contract manufacturing filtered cigars, and began producing RED SUN, our own proprietary cigarette brand. As a result, 22nd Century reported net revenue for the three months ended March 31, 2015 of $616,000 (as compared to revenues of $529,000 for the entire year of 2014). The Company reported a net loss for the three months ended March 31, 2015 of approximately $4.1 million (with approximately $2.6 million of such amount consisting of non-cash expenses) and utilized cash in operations of approximately $2.5 million with approximately $1.4 million of such amount representing the cash portion of the net loss, and approximately $1.1 million of such amount being used for working capital related to operations.
Going forward, the Company expects to generate revenue in excess of $1.5 million in the second quarter of 2015, and substantially more than $5 million in revenue for the year.
Business Highlights and Updates
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The launch of MAGIC 0, the world’s lowest nicotine tobacco cigarette, has thus far exceeded expectations. As of late last week, MAGIC cigarettes are available to consumers at approximately 1,137 retail shops across Spain. The MAGIC cigarettes store count in Spain should exceed 2,500 by the end of this year.
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Later this year, the Company anticipates expanding distribution of MAGIC cigarettes across Europe. Over the course of the next several months, management intends to begin distributing MAGIC cigarettes in the U.K., France, Italy and Belgium.
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As the first company in more than six years approved to become a new signatory to the Master Settlement Agreement between the tobacco industry and the 46 Settling States (as a result of our acquisition of NASCO Products, LLC), 22nd Century moved forward with the regulatory process of listing our cigarette brands on the state tobacco directories of approved products in the 50 states. To date, the Company has succeeded in having RED SUN approved for sale in 49 states, in addition to the District of Columbia. Approval for the final state, Louisiana, is expected by this summer.
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This summer, 22nd Century’s marketing team will add a significant consumer-oriented component to its domestic RED SUN advertising efforts. Having achieved distribution for RED SUN cigarettes in select markets across the U.S., the Company is now planning to speak directly to consumers – in retail stores in key demographic markets – in a campaign designed to convert premium-brand smokers to RED SUN.
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As a part of this new consumer-focused marketing effort, the Company recently launched social media accounts on Facebook, Twitter, and Instagram. Links to each social media platform are available on our website at www.redsuncigarettes.com. Consumers can also find our social media accounts directly by searching for “RED SUN Cigarettes” from each social media site. For convenience, links to the Company’s Twitter and Facebook accounts are below (Instagram is primarily a mobile application; consequently it is not readily accessible from an outside link):
https://twitter.com/redsuncigs
https://www.facebook.com/pages/RED-SUN-Cigarettes/426836574134641
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The Company is on schedule to submit an application to the FDA relating to its very low nicotine, modified risk cigarettes in development. The Company expects to present a completed application to the FDA this summer.
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22nd Century continues to seek a suitable joint venture partner to fund a Phase III clinical trial for X-22, the Company’s tobacco-based smoking cessation aid in development. Management has engaged in, and continues to engage in, discussions with potential joint venture partners located in the United States, Europe, Asia and the Middle East.
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22nd Century continues to move forward with potential joint venture opportunities in Asia. The Company is investigating potential business opportunities in China, South Korea and Japan for the Company’s unique tobaccos and finished cigarettes. The Company remains optimistic that it will be able to announce one or more business contracts with Asian partners in 2015.
First Quarter 2015 Financial Summary
For three months ended March 31, 2015, net revenue was $616,000 compared to $448,000 of net revenue for the three months ended March 31, 2014. The first quarter 2015 net revenues of $616,000 were generated from the manufacture and sale of a third-party MSA cigarette brand, filtered cigars, and our own proprietary cigarette brand, RED SUN. The first quarter 2014 net revenues consisted of $448,000 generated from the sale ofSPECTRUM research cigarettes to the National Institute on Drug Abuse (“NIDA”).
For the three months ended March 31, 2015, we reported an operating loss of $4.1 million as compared to an operating loss in the amount of $1.2 million for the three months ended March 31, 2014. The increase in the operating loss of $2.9 million is primarily the result of increases in General and Administrative expenses of approximately $2.6 million (of which $2.1 million of the increase pertained to non-cash equity based compensation), and Sales and Marketing expenses of approximately $100,000, and a decrease in gross profit of approximately $300,000.
The Company’s net loss for the three months ended March 31, 2015 was $4.1 million, or ($0.06) per share, as compared to a net loss of $5.3 million, or ($0.09) per share, for the three months ended March 31, 2014; a decrease in the net loss of approximately $1.2 million. The reduction in the net loss is primarily attributable to a decrease in the non-cash change in the fair value of derivatives (warrant liability) in the approximate amount of $4.1 million, partially offset by the $2.9 million increase in the operating loss discussed in the previous paragraph.
Adjusted EBITDA (as described in the paragraph and tables below) for the three months ended March 31, 2015 was a negative $1.5 million, or ($0.02) per share, and a negative $0.8 million, or ($0.01) per share, for the three months ended March 31, 2014.
Below is a table containing information relating to the Company’s Adjusted EBITDA for the three months ended March 31, 2015 and 2014, including a reconciliation of net loss to Adjusted EBITDA for such periods.
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|
|
|
|
|
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Three Months Ended March 31,
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2015
|
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2014
|
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% Change
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|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
$ |
(4,116,739 |
) |
|
$ |
(5,315,128 |
) |
|
-23 |
% |
Adjustments: |
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|
|
|
|
|
|
|
Warrant liability (gain) loss - net |
|
|
|
|
(59,213 |
) |
|
|
4,067,270 |
|
|
-101 |
% |
Warrant amendment inducement expense |
|
|
|
|
- |
|
|
|
144,548 |
|
|
-100 |
% |
Depreciation and amortization |
|
|
|
|
160,891 |
|
|
|
71,269 |
|
|
126 |
% |
Loss on equity investment |
|
|
|
|
50,981 |
|
|
|
- |
|
|
100 |
% |
Interest expense |
|
|
|
|
5,508 |
|
|
|
1,749 |
|
|
215 |
% |
Stock based compensation |
|
|
|
|
2,441,205 |
|
|
|
356,684 |
|
|
584 |
% |
Gain on the sale of machinery and equipment |
|
|
|
|
- |
|
|
|
(85,621 |
) |
|
-100 |
% |
|
|
|
|
|
|
|
|
|
Adjusted EBITDA |
|
|
|
$ |
(1,517,367 |
) |
|
$ |
(759,229 |
) |
|
100 |
% |
|
|
|
|
|
|
|
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|
Adjusted EBITDA is a financial measure not prepared in accordance with generally accepted accounting principles (“GAAP”). In order to calculate Adjusted EBITDA, the Company adjusts the net loss for certain non-cash and non-operating income and expense items listed in the table above in order to measure the Company’s operating performance. The Company believes that Adjusted EBITDA is an important measure that supplements discussion and analysis of its operations and enhances an understanding of its operating performance. While management considers Adjusted EBITDA to be important, it should be considered in addition to, but not as a substitute for or superior to, other measures of financial performance prepared in accordance with GAAP, such as operating loss, net loss and cash flows from operations. Adjusted EBITDA is susceptible to varying calculations and the Company’s measurement of Adjusted EBITDA may not be comparable to those of other companies.
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 and 52 pending patent applications 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 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.
RE: XXII from streamingeagle88 - admin - 05-31-2015
Latest update from Chardan here.
RE: XXII from streamingeagle88 - admin - 09-05-2015
22nd Century Launches Website in 8 Languages Detailing Science and Clinical Studies for Worlds Lowest Nicotine Tobacco; Company to Present at Rodman & Renshaw Global Investment Conference on September 9th
CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (XXII) (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today that the Company has launched a new website for its 0.0 mg nicotine MAGIC 0 brand cigarettes.
Launched in Europe in April 2015, MAGIC 0 cigarettes feature the natural tobacco taste of conventional cigarettes, but are made with the worlds lowest nicotine tobacco. Without any artificial extraction or chemical processes, MAGIC 0 yields only 0.04 mg of nicotine per cigarette 95% less nicotine than conventional cigarettes. No other company can grow tobacco with such low nicotine content. In accordance with European regulations which require cigarette manufacturers to list the nicotine yield directly on each pack of cigarettes and to round the yield to the nearest 1/10 place, MAGIC 0 packs prominently feature the words: 0.0 mg nicotine.
Visitors to the new MAGIC website are provided details on the science that makes the worlds lowest nicotine cigarettes possible. The website also showcases 5 independent clinical trials that have used cigarettes made with 22nd Centurys proprietary Very Low Nicotine tobacco. With world-wide public health implications, www.magiccigarettes.com is available in 8 languages including English, Spanish, French, Italian, Dutch, German, Chinese, and Japanese.
22nd Century believes that its proprietary cigarettes protected by a very large number of patents and supported by a host of independent clinical studies will be the first combustible cigarettes authorized by the FDA to be marketed as reduced exposure products, explained Henry Sicignano III, President and Chief Executive Officer. 22nd Century will submit its application to the FDA this fall and we look forward to receiving FDA authorization to properly label and market our extraordinary Very Low Nicotine cigarettes in the United States.
To date, no big tobacco companies have been authorized to market their cigarettes as reduced exposure or modified risk tobacco products. In fact, on August 27, 2015, the FDA Center for Tobacco Products issued a warning letter to Natural American Spirit maker Santa Fe Natural Tobacco Company Inc. for representing explicitly and/or implicitly that [Natural American Spirit cigarettes] or their smoke do not contain or are free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products. Santa Fe was ordered by the FDA to immediately correct the violations and to take any necessary actions to bring its tobacco products into compliance with the federal Food, Drug, and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act.
In related news, 22nd Century Group today announced that it will present at the Rodman & Renshaw 17th Annual Global Investment Conference on September 9, 2015 at the St. Regis Hotel, New York City. Mr. Sicignano and Chief Financial Officer, John T. Brodfuehrer, will discuss the Companys plans for expansion of the Very Low Nicotine product line as well as business highlights for the Company generally.
Mr. Sicignano and Mr. Brodfuehrer will also be available for one-on-one meetings with investors. To arrange a meeting with the Companys executive management, please contact Andrew Haag at xxii@irthcommunications.com or 1-866-976-4784.
RE: XXII from streamingeagle88 - admin - 10-05-2015
CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. ( XXII) (NYSE MKT: XXII), a leader in tobacco harm reduction, announced that The New England Journal of Medicine has published a special article describing a milestone study that used the Companys proprietary SPECTRUM research cigarettes ( N Engl J Med 2015; 373:1340-1349). The Center for the Evaluation of Nicotine in Cigarettes led the double-blind, parallel, randomized clinical trial involving 840 smokers at ten locations. The authors concluded that data from the study suggests, as compared with cigarettes of conventional nicotine content, 22nd Centurys proprietary low nicotine SPECTRUM cigarettes were associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.
The study, which was funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, included six styles of 22nd Centurys SPECTRUM research cigarettes. The SPECTRUM cigarettes had nicotine contents ranging from 15.8 mg per gram of tobacco (similar to commercial brands) to 0.4 mg per gram (very low nicotine). The very low nicotine SPECTRUM cigarettes contain 95% less nicotine than conventional cigarettes. 22nd Century is the only company in the world capable of growing tobacco with such low nicotine content.
Researchers found that during the 6th and final week of the trial, participants who were assigned 22nd Century SPECTRUM cigarettes with 0.4 mg/g nicotine smoked fewer cigarettes per day (14.9) than those assigned to their usual brand (22.2). In fact, very low nicotine cigarettes were found to reduce exposure to, and dependence on, nicotine and to reduce cravings while adverse events were generally mild and similar among groups. Moreover, in the 30 days following the trial, smokers of very low nicotine cigarettes reported they attempted to quit smoking at a rate double that of participants who smoked cigarettes with 15.8 mg/gram nicotine (34.7% vs. 17%).
The studys lead author, Dr. Eric Donny, explained in an article posted on usatoday.com, "The evidence is getting stronger that reducing nicotine reduces smoking and makes people less addicted to cigarettes and, in doing so, might make them more likely to quit." To further test this theory, 22nd Centurys proprietary SPECTRUM cigarettes are being used in a Phase III clinical study that follows 1,250 smokers for five months (ClinicalTrials.gov NCT02139930).
The results of previous studies using very low nicotine cigarettes have demonstrated a host of desirable outcomes including reduced smoking, reduced nicotine exposure, reduce nicotine dependence, increased abstinence, reduced exposure to toxicants and few adverse events with little evidence of withdrawal-related discomfort or safety concerns. Unlike light cigarettes (as previously labeled and marketed by conventional tobacco companies) which reduce machine-smoking nicotine yields by diluting the smoke rather than by reducing the nicotine content of the tobacco itself, very low nicotine cigarettes do not result in compensatory smoking.
In the past 8 years, the prospect of reducing the addictiveness of cigarettes has received renewed attention from numerous health organizations, including the Institute of Medicine, the World Health Organization (WHO) and the Office of the U.S. Surgeon General. The Tobacco Control Act, enacted in 2009, granted the FDA authority to set standards that reduce the nicotine content of all cigarettes sold in the United States.
The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy& explained public health policy reform advocates, Drs. Michael Fiore andTimothy Baker in a companion article in the same issue of the NEJM. Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.
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 Companys mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 185 issued patents and more than 50 pending patent applications around the world. The Companys strong IP position led to a licensing agreement with British American Tobacco (BAT), the worlds 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 year ended December 31, 2014, filed on February 6, 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.
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