22nd Century is a plant biotechnology company with an important mission: To Reduce the Harm Caused by Smoking. Our proprietary genetic engineering technology and plant breeding expertise allow us to regulate the level of nicotine (and other nicotinic alkaloids) in the tobacco plant. As a result of our unique technology, we are able to grow tobacco with up to 97% less nicotine than conventional tobacco – as well as plants with relatively high nicotine levels. The applications for this technology are extraordinary; in independent clinical studies, our very low nicotine (VLN) tobacco has demonstrated remarkable efficacy as a smoking cessation aid. On the other hand, for smokers who do not wish to quit, our high nicotine tobacco enables us to produce a cigarette with what we believe is the world’s lowest tar-to-nicotine ratio. We have an extensive intellectual property portfolio of issued patents and patent applications relating to the tobacco and cannabis plants. http://www.xxiicentury.com/
22nd Century Raises 2017 Revenue Projection to $16Million – Another Record Year May 09, 2017 Factory will be profitable in 2018 CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company, announced today that the Company’s wholly-owned subsidiary, NASCO Products, recently entered into substantial new manufacturing agreements for the production of filtered cigars and other tobacco products. The products to be manufactured by 22nd Century as a result of these executed new contracts are currently supplied to more than 250 distributors and wholesalers and more than 40,000 retail stores across the United States. In order to accommodate this sizeable increase in business, 22nd Century has already hired 37 new employees, more than doubling its workforce at the Company’s NASCO factory in Mocksville, North Carolina. When combined with existing business, 22nd Century is raising its 2017 total revenue projection from a previously announced $12,000,000 to more than $16,000,000. In 2018, 22nd Century anticipates total revenues will significantly exceed $20,000,000 and the Company’s factory will be cash flow positive. “Our manufacturing facility is a vital strategic asset for 22nd Century Group,” explained Henry Sicignano, III, President and Chief Executive Officer at 22nd Century. “The factory enables 22nd Century to develop and manufacture the Company’s SPECTRUM® government research cigarettes, our X-22 smoking cessation cigarettes in development, and 22nd Century’s proprietary MRTP candidates: BRAND A Very Low Nicotine cigarettes, and BRAND B low tar-to-nicotine ratio cigarettes. Now, considering the newly signed contract manufacturing agreements, our NASCO production facility will also contribute positively to 22nd Century’s bottom line.”
22nd Century Group Receives Order for 2.4 Million SPECTRUM® U.S. Government Research Cigarettes June 01, 2017 CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is focused on tobacco harm reduction and cannabis research, announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, received a new purchase order for agencies of the U.S. federal government for 2.4 million of the Company’s proprietary SPECTRUMresearch cigarettes. SPECTRUMbrand cigarettes are an important tool in clinical research for investigating the impact of reduced nicotine levels for cigarette addictiveness and cessation success. As recently reported, scientists have dramatically increased the number of clinical trials investigating the important applications of Very Low Nicotine cigarettes. New and on-going independent clinical trials have increased demand for 22nd Century’s proprietary SPECTRUM research cigarettes. In-progress clinical research incorporating the use of SPECTRUMcigarettes includes: (i) exposure studies comparing how different nicotine levels in cigarettes affect smoking behavior, (ii) smoking cessation studies, and (iii) studies to determine the nicotine addiction threshold of cigarettes. Most notable is a newly completed, but not yet published, Phase III study featuring 1,250 participants and funded by the National Institute on Drug Abuse (NIDA). This study is comparing two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels versus a gradual reduction in nicotine content in cigarettes to non-addictive levels. This seminal Phase III study is expected to determine the nicotine reduction approach that demonstrates the most favorable outcomes for smokers; no matter which approach prevails, 22nd Century’s Very Low Nicotine tobacco and technology will be a key component. 22nd Century developed SPECTRUMin partnership with independent researchers and officials from the NIDA, the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC). The main SPECTRUMproduct line, which can only be produced by 22nd Century, consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than conventional brands) to relatively high nicotine yields. SPECTRUMfeatures 24 styles, in both regular and menthol versions, with 8 different levels of nicotine in its tobacco. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUMbrand styles. Including this new order, Goodrich Tobacco has received orders for more than 24 million SPECTRUMcigarettes. SPECTRUMcigarettes are not sold commercially; they are produced by 22nd Century for exclusive use in independent clinical research. “Today there are at least 25 ongoing clinical trials using 22nd Century’s proprietary Very Low Nicotine cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We expect that this new order of SPECTRUM research cigarettes will facilitate critical additional research… and will ultimately lead to 22nd Century making Very Low Nicotine cigarettes available to smokers around the world.”
22nd Century Produces Non-GMO Very Low Nicotine Tobacco June 06, 2017 Non-GMO tobacco varieties will open new markets worldwide CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is focused on tobacco harm reduction and cannabis research, announced today that the Company’s research collaboration with North Carolina State University has yielded several new Very Low Nicotine (VLN) tobacco varieties that contain no foreign DNA and no trace of genetic modification. The new Very Low Nicotine varieties are ideally suited for use in the Company’s X-22 smoking cessation product in development and will also form the basis of other unique 22nd Century VLN products. In the United States, federal regulation will not treat the new Very Low Nicotine tobacco varieties as “genetically modified;” further, these new proprietary tobacco strains will not be subject to burdensome regulation and import restrictions in most countries around the world. Representing a major improvement on the Company’s already successful Very Low Nicotine tobacco, the new proprietary varieties hold immense promise to open up large international markets for the Company. 22nd Century is already in contact with marketers and distributors in countries with GMO restrictions (Japan, India, and Korea) to facilitate the import of products based on the Company’s new non-GMO Very Low Nicotine tobaccos. These second generation non-GMO VLN tobacco varieties also show improved ripening and curing qualities. 22nd Century’s new non-GMO Very Low Nicotine tobaccos not only lack foreign DNA, but they are also based on superior foundational varieties. One of 22nd Century’s new non-GMO lines is based on a flue cured variety known for its superior growing characteristics and curability, while another of the Company’s non-GMO lines is based on one of the most widely grown air-cured burley tobaccos that has excellent disease resistance and yield potential. These new non-GMO Very Low Nicotine tobacco varieties are already under cultivation and study in the Company’s laboratories in Buffalo, New York. 22nd Century anticipates having commercial quantities of seed for the non-GMO varieties by 2018. The non-GMO Very Low Nicotine tobacco varieties are protected by numerous patents under 22nd Century’s extensive patent portfolio. The Company’s patents also protect additional second generation varieties that are currently in development for the Company at North Carolina State University and in 22nd Century’s own laboratories. “We are absolutely delighted that we have achieved our goal of producing non-GMO Very Low Nicotine tobacco,” explained Dr. Paul Rushton, 22nd Century’s Vice President for Plant Biotechnology. “Because our new non-GMO varieties contain no foreign DNA, these proprietary varieties will open up huge new markets around the world. What’s more, 22nd Century’s second-generation non-GMO VLN tobacco varieties produce an even higher quality tobacco that will further improve our Very Low Nicotine finished products.” Professor Ralph Dewey, the Principal Investigator at North Carolina State University, stated, “We are extremely pleased that our project with 22nd Century has been such a success. These exciting new varieties will create important new Very Low Nicotine tobacco products that will avoid the GMO label. We are also pleased that our projects with 22nd Century are ongoing and that we very well may produce exciting additional VLN varieties in the coming months.”
XXII Products: X-22: Smoking Cessation Aid In Development X-22 is a kit containing Very Low Nicotine (VLN) cigarettes that will go through the FDA-approval process as a prescription smoking cessation aid. Modified Risk Cigarettes: Brand A (In Development) Brand B (In Development) SPECTRUM Government Research Cigarettes MAGIC 0 and MAGIC 2 MOONLIGHT RED SUN Variable Nicotine-Level Research Cigarettes Verfola™ A Novel High-Yield Leaf Crop for Integrated Production of Bioproducts
Here’s Why 22nd Century Group Inc (NYSEMKT:XXII) Could Be The Only Play On The Back Of A Global Shift In The Tobacco Industry By Samuel Rae - April 6, 2017 - 14:33 BST In 2015, the World Health Organization (WHO) published an Advisory Note titled Global Nicotine Reduction Strategy. It’s a 36-page report, put together for the purpose of presenting the conclusions and recommendations of the members of an WHO Study Group on Tobacco Product Regulation, called TobReg, on a policy for limiting the sale of cigarettes to brands with a nicotine content that is not sufficient to lead to the development and/or maintenance of addiction. The justification behind such limitation is simple – if an individual is only able to gain access to (and in turn, consume) a cigarette that doesn’t contain enough nicotine to induce addiction, then overall consumption should decline. The Advisory Note details a number of takeaways, each of which are important considerations in getting a policy like that under discussion into practice. The primary conclusion, however, was as follows: that no specific amount of nicotine has yet been identified as the absolute threshold for addiction; however, it is likely to be equal to or possibly less than 0.4 mg/g of dry cigarette tobacco filler. If such a policy came in to force, the tobacco industry would be turned on its head. This addiction threshold represents a 95% reduction in nicotine versus the conventional cigarette brands that are on the market today, meaning the leading brands, produced and sold by Big Tobacco and its constituent behemoths (Philip Morris International Inc. (NYSEM), British American Tobacco PLC (ADR) (NYSEMKT:BTI), etc.) would become obsolete under its recommendation. When regulatory advance shakes up markets like this one has the potential to do, there are generally winners and losers, and in turn, opportunities to back the companies that fall within the former category. In this instance, however, one company stands out as having the potential to gain more than any other if policy like the above discussed comes in to force. The company is 22nd Century Group Inc (NYSEMKT:XXII). Right now, 22nd Century is the only company in the world capable of producing combustible tobacco cigarettes at this very low level of nicotine, without having to incorporate the inclusion of any artificial extraction or chemical processes into its manufacturing process. The company has developed a proprietary technology that allows it to regulate the level of nicotine present in tobacco plants without impacting the elements of the tobacco leaf that are responsible for characteristics like taste, aroma, that sort of thing. The technology is protected by more than 200 issued patents and more than 50 patent pending applications globally, and underpins a suite of tobacco products that make up 22nd Century’s commercial product portfolio. How does it work? The technology is rooted in regulation by genetic engineering of what’s called the nicotine biosynthetic pathway. By way of a simplified explanation of how it works, nicotine is produced in the roots of tobacco plants by the linking of compounds from what are called nicotinic acid and putrescine. By altering the genetic profile of the plant, the company is able to regulate this linking, and in turn, regulate the creation of what are called nicotinic alkaloids. Nicotine (the form found in commercial tobacco products) is an example of one of these alkaloids. Anyway, understanding the science isn’t overly important from an investment perspective. What’s important is this process allows the company to basically dial the nicotine content of its plants up and down, at growth stage. Other companies need to use outside input to do this, post harvest; 22nd Century doesn’t. So the WHO has recommended mandated reductions in nicotine to minimally addictive levels. Right now, there’s no option available to smokers in many global regions – the US included. 22nd Century is working to fill this gap in the market, and it’s the company’s efforts towards this aim that underpin a long term value thesis on the stock. There’s a large database of clinical investigation that underpins the suggestion that a very low nicotine product can lead to reduced cigarette consumption, and this has given 22nd Century plenty of ammunition to take to the FDA as supportive of getting a product developed using the above discussed technology to market with an FDA recommendation and approval. Back in January 2017, the company announced that the FDA had provided positive feedback on the product it’s trying to bring to market to take advantage of the WHO mandate recommendations. 22nd Century currently refers to it only as Brand A, and on the back of the FDA feedback just noted, the company is working on a Modified Risk Tobacco Product (MRTP) application that – if approved – will allow 22nd Century to market the brand as reducing the smoker’s exposure to nicotine. Parallel to the MRTP, the company is also preparing a Pre Market Tobacco (PMT) application, the approval of which is necessary before it can start selling Brand A in the US. Prior to the January guidance, these two applications were combined. Post-guidance, 22nd Century has broken them into two separate applications, based on the potentially shorter turnaround time of the PMT as compared to the MRTP. This means we could see the PMT granted near term, allowing the company to sell its Brand A in the US (although we don’t expect management will start doing so until the MRTP is granted, the PMT is a near term upside catalyst). Policy change driven potential aside, this company is already selling branded tobacco products in the US, and generated more than $12 million in revenues from these products during 2016. This is up from the $8.5 million reported during 2015. Further, in management’s most recent letter to shareholders, CEO Henry Sicignano stated that already signed contracts amount to an increase in revenues for 2017 over the full year 2016 number. With that said, however, the real long term value for this company (and in turn, its shareholders) is rooted in the regulatory side of the picture, and again referencing the recent CEO letter, its operational focus points towards recognition of this fact. Sicignano noted that a number of shareholders had expressed opinions that 22nd Century should cease all current sales efforts and focus on maximizing potential regulatory advance. He followed this up with the statement that company focus will be on regulatory efforts, and that this side of the expansion strategy could lead to the generating of hundreds of millions of dollars annually from Brand A and other products. And it’s not all about tobacco. 22nd Century has taken the concept outlined above (genetic alteration of plants to impact adult plant composition) and applied it to cannabis plants. The goal? To reduce, or remove entirely, the THC component of the plant. For those not familiar with the cannabis space, THC is the psychoactive compound of the cannabis plant – the part that causes the mind altering effects on consumption. In the recreational consumption space, of course, THC is a desired ingredient. In other areas of the industry, however, the opposite is true. Take hemp, for example. Right now, people don’t grow hemp on a commercial scale in the US. It’s possible, of course, and it’s legal. And it could be incredibly profitable. So why isn’t it happening? Because it’s risky. Hemp is defined by what’s called Section 7606 of the Agricultural Act, and to qualify as hemp (as opposed to marijuana) under this act, it’s got to contain 0.3% or less THC on a dry weight basis. Any more, and the government can legally force a farmer to destroy an entire crop of hemp, since it’s ‘legally’ classed as cannabis. 22nd Century’s answer to this situation was to develop a cannabis plant that contains 0% THC, effectively removing the risk from the equation for US farmers. There’s a similar type of application in the medical marijuana space. Many of today’s medical marijuana drugs are rooted on CBD as opposed to THC. The ‘high’ associated with the THC is often regarded as an unwanted side effect. With its 0% THC yields, 22nd Century’s plants basically negate this problem at grow stage. The cannabis side of the company is at the research stage right now, and it’s not going to be a primary value driver near term. That said, it has the potential to add considerable value as the hemp farming and cannabis industry matures in the US and internationally. So what’s next? It’s all about progress on the regulatory front. There are a number of ongoing studies investigating the impact of very low nicotine products on cigarette consumption, and as these complete, they should serve to reinforce 22nd Century’s application to the FDA for marketing authorization, and on a more macro scale, the justification for an industry wide mandate as outlined by the WHO document referenced in the introduction to this piece. These studies, in turn, serve as catalysts for near term growth as and when they hit press. Additionally, information released by the company relating to program-specific regulatory developments in various regions (one of the most interesting of which is a UK program referenced in the most recent shareholder letter as well as the latest conference call) will offer clarity into potential penetration into the markets of said various regions. The author holds no positions in the above mentioned companies.
Good day today, broke the 52-week high and some key resistance areas. If anyone is looking for a good smoking cessation, hemp, MJ (0% THC) stock and is willing to do some reading...
FDA's Plan to Lower Nicotine in Cigarettes to Non-Addictive Levels Shines Spotlight on 22nd Century Group 22nd Century is the only company in the world capable of growing tobacco with non-addictive levels of nicotine. CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is focused on tobacco harm reduction, stated today that the Company welcomes the announcement by the United States Food and Drug Administration (FDA) that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in combustible cigarettes sold in the United States. 22nd Century is already capable of achieving the FDA’s ambitious new product standard. As previously reported, 22nd Century is the only company in the world capable of growing tobacco with non-addictive levels of nicotine. The Company’s proprietary Very Low Nicotine tobacco is grown on independently-owned farms in the United States – without any artificial extraction or chemical processes. 22nd Century uses its proprietary and patent-protected Very Low Nicotine tobacco to produce the world’s lowest nicotine tobacco cigarettes. 22nd Century’s Very Low Nicotine cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®. 22nd Century’s Very Low Nicotine cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so that smokers’ exposure to nicotine is reduced drastically. In the FDA announcement on July 28, 2017, FDA Commissioner Scott Gottlieb, M.D., stated that “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users. Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground." In a June 16, 2010 press release, Dr. David Kessler, the former FDA Commissioner, recommended that “[t]he FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels. If we reduce the level of the stimulus, we reduce the craving. It is the ultimate harm reduction strategy.” Shortly thereafter, in a Washington Post newspaper article, Dr. Kessler said that the amount of nicotine in a cigarette should drop from about 10 milligrams to less than 1 milligram. By producing cigarettes that contain less than 0.6 mg of nicotine per cigarette, 22nd Century has already met Dr. Kessler’s standard and has simultaneously demonstrated that the FDA’s targets are both technically achievable and realistic. In order to provide public health officials, tobacco industry competitors, and the general public with compelling scientific data in support of Very Low Nicotine cigarettes, 22nd Century has partnered with independent researchers and officials from the FDA, the National Institute of Drug Abuse (NIDA), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC), to develop SPECTRUM® brand research cigarettes. 22nd Century has already delivered more than 22 million SPECTRUM cigarettes and recently received a new purchase order for 2.4 million additional government research cigarettes. Utilized by dozens of independent scientists and researchers over the past several years, the SPECTRUMproduct line consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than conventional brands) to relatively high nicotine yields. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUMbrand styles. Separate from the SPECTRUM research cigarettes program, 22nd Century was also chosen to supply the Company’s proprietary Very Low Nicotine fine cut tobacco to the FDA for additional research. Agencies of the U.S. federal government have invested more than $100 million on independent clinical research with SPECTRUM cigarettes that supports the conclusion that lowering nicotine levels in combustible tobacco cigarettes would drastically improve public health. Public health policy reform advocates, Drs. Michael Fiore and Timothy Baker wrote in The New England Journal of Medicine: “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.” Building on the large and growing body of clinical research in support of Very Low Nicotine cigarettes, the World Health Organization (WHO) cited 22nd Century’s proprietary tobacco cigarettes in its recommendation that all WHO-member countries mandate reductions in nicotine in combustible tobacco cigarettes to non-addictive levels. A landmark clinical study cited by WHO in its recommendation – and likely influential in FDA’s stated intention to reduce nicotine levels – was published in The New England Journal of Medicine in 2015. The authors of the study, led by the Center for the Evaluation of Nicotine in Cigarettes, concluded that 22nd Century’s proprietary Very 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.” Links and a brief summary of 17 completed clinical trials using the 22nd Century’s Very Low Nicotine cigarettes are provided at the Company’s website. Today there are at least 25 ongoing clinical trials using 22nd Century’s proprietary Very Low Nicotine cigarettes. “We are thrilled that FDA is now moving to lower nicotine in combustible cigarettes to non-addictive levels; this is a technically achievable standard whose time has come,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “With a mountain of science and evidence supporting our Very Low Nicotine products, 22nd Century stands ready to partner with the FDA – and with any Big Tobacco companies that are truly committed to improving the health of American smokers.” Mr. Sicignano concluded, “Lowering nicotine in cigarettes to non-addictive levels will save millions of lives and billions in healthcare costs; 22nd Century is proud to have such an important role in this public policy imperative.” About 22nd Century Group, Inc. 22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.comfor 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, 2016, filed on March 8, 2017, 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. View source version on businesswire.com: http://www.businesswire.com/news/home/20170731005377/en/ 22nd Century Group Investor Relations: IRTH Communications Andrew Haag, 866-976-4784 [email protected] Source: 22nd Century Group, Inc. Released July 31, 2017
Not going to post anymore WRT a smoking cessation aid... and reduced nicotine product... but this has the potenitial to turn multiples even from here.
22nd Century Now Free of Restrictive License Agreement with British American Tobacco $25 Million Royalty Cap is Null and Void. XXII is Now Able to Pursue Much More Lucrative Strategic Partnerships. CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, is pleased to announce that the 2013 Research License and Commercial Option Agreement between the Company and British American Tobacco (Investments) Limited (“BAT”) is now finished. BAT no longer has rights to any intellectual property or other assets of 22nd Century; 22nd Century is now again in sole control of the Company’s highly disruptive intellectual property portfolio relating to the ability to grow patent-protected Very Low Nicotine tobacco plants. Accordingly, the Company has recommenced discussions with global tobacco companies and international pharmaceutical companies that have expressed strong interest in a business relationship with 22nd Century but were, until now, unable to enter into a licensing agreement with 22nd Century due to restrictive covenants contained in the BAT agreement. Under the restrictive terms of the BAT agreement, annual royalties to 22nd Century were capped at $25 million per year. Now that the agreement has been terminated, the Company is free to engage in licensing agreements and strategic partnerships with any and all tobacco companies – with no restrictions, limits, or “caps” on licensing royalties. This development is especially significant in light of the announcement made at the end of July by the United States Food and Drug Administration (“FDA”). On July 28, 2017, the FDA publicly announced that it is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at minimally or non-addictive levels – in all combustible cigarettes sold in the United States. 22nd Century is the only company in the world capable of growing tobacco with just 0.4mg/g nicotine content – a 95% reduction in nicotine. As a result of the FDA’s newly announced plan, minimally or non-addictive Very Low Nicotine tobacco will be a required ingredient of every cigarette sold in the United States. This unprecedented FDA action represents a paradigm shift for the tobacco industry and, according to Stanford Professor Robert N. Proctor, Ph.D., “could save more lives than any other act of a government agency in all of human history.” Called “the ultimate harm reduction strategy” by former FDA Commissioner Dr. David Kessler, the planned FDA mandate to reduce nicotine levels in cigarettes to minimally or non-addictive levels is the result of a multitude of independent clinical studies. As reported in the October 2015 New England Journal of Medicine (N Engl J Med 2015; 373:1340-1349), independent researchers found 22nd Century’s proprietary Very 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.” To facilitate dozens of additional completed and on-going independent clinical studies, 22nd Century has manufactured more than 22 million SPECTRUM® government research cigarettes containing the Company’s proprietary VLN tobacco. Agencies of the U.S. federal government have invested more than $100 million in independent clinical research with SPECTRUM cigarettes that supports the conclusion that lowering nicotine levels in combustible tobacco cigarettes would drastically improve public health. In total, more than 100 completed and on-going independent clinical trials, scientific commentaries, and other publications relating to 22nd Century’s VLN tobacco have captured the attention of public health advocates and tobacco industry executives around the world. Philip Morris International CEO Andre Calantzopoulos explained to Reuters thathe believes the FDA's plan is "one of the best articulated positions in many years." Mr. Calantzopoulos also does not believe it is inevitable that the industry will pursue litigation to fight regulators on the issue. “It appears that BAT is so far behind Philip Morris International in its heat-not-burn product development that BAT has now myopically narrowed its focus to non-combustible devices instead of reduced exposure combustible cigarettes,” stated Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “In this new world, where the FDA and the World Health Organization have called for mandated, dramatic reductions of nicotine in cigarettes, we are absolutely thrilledto once again be in sole and complete control of our technology and the incredible licensing opportunities that lay before us.” Mr. Sicignano concluded, “22nd Century’s proprietary Very Low Nicotine cigarettes – with minimally or non-addictive levels of nicotine – will save millions of lives and billions in healthcare costs. Our Company is proud to have such an important role in this public policy imperative.” About 22nd Century Group, Inc. 22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.
Pretty big news this morning. Phase III Study Using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction To Very Low Nicotine Is Most Likely To Lead To Less Harm “Minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy” CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that Dr. Dorothy Hatsukami, at the Vermont Center on Behavior and Health’s 5th Annual Conference on Tobacco Regulatory Science, revealed the fundamental findings of a highly anticipated 1,250-patient, 20-week study that compared smokers who were assigned to: i) an immediate reduction to Very Low Nicotine cigarettes; ii) gradual reduction in reduced nicotine content cigarettes; or iii) normal nicotine content cigarettes.Designed to determine which approach produces the most optimal outcomes for smokers, the announcement of the results of the seminal phase III study comes only weeks after the United States Food and Drug Administration (FDA) announced that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in all combustible cigarettes sold in the United States. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171006005223/en/ 22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine reduction strategies. The FDA plans to mandate lower nicotine – at non-addictive levels – in all cigarettes sold in the United States. (Photo: Business Wire) Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics. 22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive. Though the details of Dr. Hatsukami’s phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study’s core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that “an immediate approach [to nicotine reduction] is most likely to lead to less harm.” Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a “greater likelihood of more rapid smoking cessation” with the immediate approach to nicotine reduction. Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins, Director of the University of Vermont Tobacco Center of Regulatory Science took the podium and announced to the conference attendees: “I will present evidence that reducing nicotine content lowers the addiction potential of smoking among those with psychiatric conditions or socioeconomic disadvantage consistent with prior evidence in samples from the general adult smoker population.” In addition to finding reduced evidence of addiction in smokers of 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr. Higgins found that: “VLNCs did notproduce evidence of compensatory smoking.” [emphasis added] Dr. Jonathan Foulds of Penn State College of Medicine also delivered a powerful call to action at the conference, challenging the attending scientists to deny the tobacco industry any diversions or strategies that could be used to delay the FDA’s planned mandate to reduce nicotine in cigarettes to very low, non-addictive levels. Dr. Foulds then pointed out the stakes involved: “Such a move [by FDA to reduce nicotine content of cigarettes] could result in one of the largest single improvements in public health ever [seen] in this country.” “Considering the results of numerous phase II and phase III studies that have been conducted with VLN cigarettes, there is now compelling and conclusive evidence that Very Low Nicotine cigarettes decrease cigarette dependence, reduce the number of cigarettes smoked per day, and increase smokers’ quit attempts,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “With the power to save millions of lives and to prevent a new generation of young people from becoming dependent on tobacco, minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy.”
Just curious if anyone else on the site is invested in XXII? FDA has given the company a lot of credibility of late.
22nd Century Group is a little biotech developing technology which allows the increase or decrease in the level of nicotine and other nicotinic alkaloids in tobacco plants. The company also has the technology to control levels of cannabinoids in cannabis plants.
Back from the dead a bit lately. MRTP from the FDA is execpted shortly. Many expect before end of month, but with the FDA I will curb my enthusiasm and expect by end of Q1 2021.
