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22nd Century Group (XXII)
Proprietary Very Low Nicotine Cigarettes Drastically Reduce Smokers Exposure to Nicotine

CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (XXII) (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that on December 31, 2015, the Companys wholly owned subsidiary, Goodrich Tobacco Company, submitted a Modified Risk Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA) seeking a reduced exposure order so that 22nd Centurys BRAND A Very Low Nicotine (VLN) cigarettes may be introduced into commerce in the United States. The application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Companys proprietary Very Low Nicotine cigarettes reduce smokers exposure to nicotine.

The Worlds Lowest Nicotine Tobacco Cigarettes

BRAND A 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®. With more than 200 patents relating to the genes in the tobacco plant responsible for nicotine production, 22nd Century is the only company in the world capable of producing virtually nicotine-free tobacco. Without any artificial extraction or chemical processes, 22nd Centurys BRAND A cigarettes are made with the Companys proprietary VLN tobacco that is grown on independently-owned farms in the United States. The finished cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so that smokers exposure to nicotine is drastically reduced.

Under Section 911 of the federal Food, Drug, and Cosmetic Act, a tobacco product may not be introduced for commerce in the United States if the label or advertising represents that the tobacco product contains a reduced level of a substance or a reduced exposure to a substance unless given specific approval to do so by the FDA.

The scientific testing conducted in support of our submission to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced exposure to nicotine, explainedHenry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. We believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited about the prospect of introducing BRAND A into the U.S. market.

It has been well established that cigarette smoking is toxic and poses health risks to smokers. Cigarette smoking is a complex behavior that is sustained primarily by the pharmacological properties of nicotine. Accordingly, many public health officials believe it is a critically important health need to provide consumers with a product that reduces exposure to nicotine. This fact echoes former U.S. FDA Commissioner Dr. David Kesslers recommendation that the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels& It is the ultimate harm reduction strategy.

Unlike so-called light or ultra-light cigarettes (which terms are now banned by the FDA from labeling and marketing in the United States), 22nd Centurys proprietary BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components. The Companys application to the FDA provides a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Centurys VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco.

Most recently, in October 2015, The New England Journal of Medicine published a landmark clinical study N Engl J Med 2015; 373:1340-1349 led by the Center for the Evaluation of Nicotine in Cigarettes. The double-blind, parallel, randomized clinical trial by Donny et al involved 840 smokers at ten locations who were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes. The researchers concluded that:

As compared with cigarettes of conventional nicotine content, 22nd Centurys proprietary Very Low Nicotine 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 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 (Fiore) in the same issue of 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.

The available scientific literature shows that smoking 22nd Centurys VLN cigarettes results in reduced nicotine exposure with minimal compensatory smoking behavior and no greater exposure to harmful or potentially harmful toxicants, particularly when exposure is maintained for longer than one week. Similarly the prolonged use of VLN cigarettes seems to result in a decrease in dependence.

It is the goal of the U.S. Department of Health and Human Services, as outlined in the program Healthy People 2010, to reduce cigarette smoking inthe United States to 12% by the year 2020, explained Gregg M. Gellman, 22nd Centurys Director of Regulatory Affairs. Based on the scientific rationale and clinical data referenced in our application to the FDA, we believe 22nd Centurys proprietary Very Low Nicotine cigarettes could be an invaluable tool in helping to drastically reduce smokers exposure to nicotine and thereby greatly reducing cravings for, and consumption of, cigarettes.

With approximately 277 billion cigarettes manufactured in the U.S. in 2014 representing more than $80 billion in sales the cigarette market in the United States remains enormous. At present, however, the United States is completely devoid of any reduced exposure cigarette option. If 22nd Centurys application to the FDA is successful, the Companys VLN cigarettes will offer millions of American smokers a distinct reduced exposure product choice.

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Here’s how it works: Under the program, 22nd Century will give $1 worth of its stock to distributors for every carton of Red Sun cigarettes they sell. Participating retailers will get $3 worth of 22nd Century stock as a rebate for every carton of Red Sun cigarettes they sell during 2015. Sell 100 cartons, get $300 in 22nd Century stock. Sell 1,000 cartons, get $3,000 in stock. If the company succeeds – and the stock goes up – the shares could be worth even more down the road. “This program is a mechanism for retailers to own stock in the brand they’re helping to build,” Sicignano said.

Recruiting mom-and-pop stores to carry cigarettes - Business - The Buffalo News

2nd Century Group (NYSE: XXII) disclosed in an SEC filing: 22nd Century Group, Inc. (the “Company”) preliminarily expects to generate revenues from the sales of products of at least $12 million for the year ending December 31, 2016, an increase of 50% when compared to the recently issued expectations for 2015.

22nd Century Group (XXII) Expects FY16 Products Sales of at Least $12M

Well in Europe, we certainly lined up distributor partners in the countries you mentioned and one or two others. So, yes, we have distributor partners and promotional partners all aligned up and ready to go. And frankly, we have specialty filters in stock to make products for those markets. So really all we need is a signed agreement with that specialty filter supplier and we are ready to move forward into those markets. So, I hope and plan for us to make those product launches very, very soon.

22nd Century Group's (XXII) CEO Henry Sicignano on Q4 2015 Results - Earnings Call Transcript | Seeking Alpha

The US may be on the cusp of creating a home-grown industry from a long-demonized plant. The US hemp industry is pushing hard for a measure that would make it legal for US businesses to produce the substance, and if lawmakers approve it, consumers could soon find US-grown hemp in their food, baby products, fabric, fuel, paint, body-care products, paper, carpet, and even auto parts.

US-grown hemp could soon find its way into your food, clothes, and cars - Quartz

More than 70 US lawmakers from both political parties—including senate majority leader Mitch McConnell and Democrat Ron Wyden—back the measure (pdf). If passed, industrial hemp would be removed from the Controlled Substances Act definition of marijuana, effectively setting free what the Congressional Research Service estimates to be a $581 million hemp-product industry in the US.

US-grown hemp could soon find its way into your food, clothes, and cars - Quartz

The success of different smoking cessation treatments could be predicted by how quickly smokers break down (metabolise) nicotine in their bodies, according to new research published in The Lancet Respiratory Medicine journal. The findings, from the largest pharmacogenetic study of tobacco dependence treatment to date, reveal that normal metabolisers of nicotine have better quit rates with the non nicotine replacement therapy drug varenicline (trade name Chantix or Champix) compared with the nicotine patch, whereas slow metabolisers achieve similar quitting success using the nicotine patch but without the side-effects reported with varenicline.

How quickly smokers metabolise nicotine may point to best quitting method

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22nd Century Group, Inc. (NYSE:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the Company has entered into a sponsored research agreement with the University of Virginia (“UVA”) and an exclusive license with the University of Virginia Patent Foundation d/b/a University of Virginia Licensing & Ventures Group (“UVA LVG”). Over the next three years, the Company will invest approximately $1,100,000 in this major scientific collaboration with UVA. The goals of the research agreement include: (i) creating unique industrial hemp plants with guaranteed levels of THC below the legal limits (thus eliminating the risk to growers of having to destroy non-conforming hemp crops) and (ii) optimizing other desirable hemp plant characteristics to improve the plant’s suitability for growing in Virginia and in similar legacy tobacco regions.

22nd Century Group (XXII) Enters Research Agreement With the University of Virginia

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22nd Century Group (XXII) Falls Following FDA Feedback on Very Low Nicotine MRTPA Filings


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22nd Century Group (NYSE: XXII) is down 9% in early trade after the company announced that the FDA has provided the Company with helpful and positive feedback on the Company’s combined Modified Risk Tobacco Product Applications (MRTPAs) and Premarket Tobacco Product Applications (PMTAs) for 22nd Century’s “BRAND A” Very Low Nicotine tobacco cigarettes.

On December 31, 2015, the Company’s wholly owned subsidiary, Goodrich Tobacco Company, submitted MRTPAs and PMTAs to the FDA seeking a reduced exposure order for 22nd Century’s “BRAND A” Very Low Nicotine cigarettes. More specifically, the Company requested in its MRTPAs permission from the FDA to be able to state, as truthful and accurate in BRAND A packaging and marketing, that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.

With less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette, BRAND A cigarettes are the world’s lowest nicotine tobacco cigarettes. Relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®, BRAND A contains 95% less nicotine. Unlike so-called “light” or “ultra-light” cigarettes (which terms are now banned by the FDA from labeling and marketing in the United States), 22nd Century’s proprietary BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components.

The Company is very pleased with the productive and encouraging communication it received from the FDA. Though the Company is only requesting an MRTP marketing order that will allow 22nd Century to disclose that BRAND A reduces smokers’ exposure to nicotine, the FDA has requested more information related to the independent clinical studies on the Company’s Very Low Nicotine tobacco that focused on smoking cessation and harm reduction objectives.

Further, though the Company’s MRTPAs and PMTAs for BRAND A included a comprehensive overview of many independent clinical trials that have found that smoking 22nd Century’s Very Low Nicotine cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco, the FDA expressed interest in receiving additional documents pertaining to research findings and statistical analyses related to the focus group studies that were conducted in support of the Company’s BRAND A applications.

In response to the FDA’s requests, and in conjunction with additional clarifying guidance, the Company has withdrawn its existing filings in order to file even more expansive and robust MRTPAs and PMTAs for BRAND A that will include additional scientific data and information from already completed clinical studies on the Company’s Very Low Nicotine tobacco cigarettes, in addition to smoking cessation research. In order to help further expedite the FDA review process, the Company also intends to bifurcate its application into separate PMTAs and MRTPAs for BRAND A to enjoy the benefit of the FDA’s shorter review timing for PMTAs as compared to MRTPAs.

As 22nd Century expands upon its discussion and interactions with the FDA’s Center for Tobacco Products (CTP) on the Company’s MRTPAs and PMTAs for its BRAND A Very Low Nicotine over-the-counter product, the Company is also continuing to separately work with the FDA’s Center for Drug Evaluation and Research (CDER) with respect to the Company’s previously-filed New Drug Application (NDA) for 22nd Century’s proposed “X-22” prescription-based smoking cessation product. Thus, 22nd Century is advancing two distinct products – one a proposed reduced exposure combustible cigarette, the other a proposed pharmaceutical smoking cessation aid – with different parts of the FDA.

The World Health Organization has recommended ‘mandated reductions in nicotine to minimally addictive levels.’ Unfortunately, at present, smokers in the United States do not have a Very Low Nicotine cigarette option,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “To address this critically important issue, we look forward to collaborating with the FDA in 2017 on both BRAND A and on X-22 in order to provide consumers access to 22nd Century’s remarkable Very Low Nicotine products.”

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Bit of a setback, this, but not necessarily fatal.
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At the time of the annual letter to shareholders in March, 22nd Century announced a decision to reallocate resources away from sales and marketing to regulatory affairs. The company generated $12 million in sales last year and still projected a sales increase in 2017 due to signed deals in the pipeline. The term "greatly exceed" is now being replaced with a sales target in excess of $16 million for 2017 and significantly beyond $20 million by 2018. Even more important, the goal is for the manufacturing factory to reach cash flow positive next year, providing the company a business outlet to offset some of the risks surrounding obtaining FDA approvals. Fellow contributor Samuel Rae recently outlined more details on the company's background and the potential issues with the FDA now in charge of approving products containing nicotine. The recent shift in regulatory authority makes the impact to 22nd Century difficult to predict.

22nd Century: No Harm Owning This Stock - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

For a small plant biotech firm, one shouldn't be surprised that 22nd Century is burning cash. For Q1, the cash balance dipped by about $2.7 million. The company ended March with $10.7 million cash on the balance sheet and the company suggests enough funds exist to fund operations until 2018. 22nd Century last raised funds back in October 2016 by selling shares and warrants for net proceeds of $11 million. The offering included 8.5 million common shares and 4.25 million warrants with an exercise price of $1.45. As well, the company raised about $10 million in a couple of other equity offerings in 2016.

22nd Century: No Harm Owning This Stock - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

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Tobacco use is the leading cause of preventable death in the U.S., taking 480,000 lives each year. It's also highly costly to society, triggering a $300 billion loss in direct healthcare and productivity costs yearly, according to the FDA. An estimated 15% or 36.5 million Americans over the age of 18 smoke cigarettes, and more than 16 million of them live with a smoking-related disease, the CDC said. The FDA's plan is for a world "where cigarettes would no longer create or sustain an addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources." That means big tobacco firms could have to change their business to cater to new combustible and non-combustible product standards. The FDA will release guidelines for what will be considered acceptable nicotine levels soon, and it expects a deadline of August 8, 2021 for combustible products and August 8, 2022 for non-combustible products to submit product reviews under those new guidelines. Stock of 22nd Century Group Inc (XXII) , a plant biotech company that focuses on altering the levels of nicotine and other nicotinic alkaloids in tobacco plants, surged 20% at the market close.

Tobacco Stocks Go Up in Smoke After FDA Issues Plan to Curb Tobacco-Related Deaths - Pg.2 - TheStreet

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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

22nd Century Group (XXII) Says FDA's Plan to Lower Nicotine in Cigarettes to Non-Addictive Levels Shines Spotlight on Company

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.

22nd Century Now Free of Restrictive License Agreement with British American Tobacco

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.

22nd Century Raises 2017 Revenue Projection to $16Million – Another Record Year

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The term "greatly exceed" is now being replaced with a sales target in excess of $16 million for 2017 and significantly beyond $20 million by 2018. Even more important, the goal is for the manufacturing factory to reach cash flow positive next year, providing the company a business outlet to offset some of the risks surrounding obtaining FDA approvals.

22nd Century: No Harm Owning This Stock - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

Back in February, the company got guidance back from the FDA on the Brand A product. Management will meet with the regulatory body's Center for Tobacco Products (CTP) this summer to discuss the MRTP application for this product. The CTP provided guidance that the company should break its previous application into separate Premarket Tobacco Product (PMT) application and a MRTP application to enjoy the benefits of a shorter review for PMT applications, while also providing more scientific data for the revised MRTP application.

22nd Century: No Harm Owning This Stock - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

If that wasn't enough, 22nd Century has a guidance meeting scheduled with the FDA's Center for Drug Evaluation and Research (CDER) to discuss the X-22 cessation product. The meeting seeks to find an appropriate path for X-22 to become a subscription-based cessation aid for smokers in the U.S. Upon an agreed path with CDER, the company plans to conduct a Phase III trial in 2018 with "fast track" status due to the serious life-threatening nature of smoking and the desire of FDA to designate such products in the program for expedited review.

22nd Century: No Harm Owning This Stock - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

The decline comes on the back of the company announcing a registered direct offering (RDO) that will see it gross $54 million from institutional investors and that, according to the press release outlining the offering, will take its cash balance to more than $60 million – enough to meet all regular operating expenses for more than five years. The company is selling 20.57 million shares in order to raise the cash and is doing so at a little over $2.66 a piece. That $2.66 is figure why it took a hit. RDOs always involve discount-to-market pricing but will often also involve warrants that serve as a sweetener for the investors buying the shares. In this instance, there are no warrants associated with the deal, meaning that while the discount isn't something investors will be cheering about (the $2.66 pricing represents an around 23% discount to open market at close prior to the RDO announcement), it could've been worse.

22nd Century Group Is Down But Could Quickly Recover - 22nd Century Group, Inc. (NYSEMKT:XXII) | Seeking Alpha

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On June 26, 2018, 22nd Century announced that it had exclusively licensed from North Carolina State University several flue-cured and burley tobacco plant lines that grow with very low levels of nicotine. These new plants contain no foreign genetic material (non-GMO) and will compliment 22nd Century’s existing VLNTM plants and technologies. The new, non-GMO, VLNTM tobacco plant lines are immediately commercially viable as they are the result of multiple generations of plantings that have yielded stable, true-breeding crop lines of flue-cured and burley tobacco plants. The addition of these non-GMO tobacco varieties represents a significant advancement for 22nd Century’s next generation tobacco technology. 22nd Century’s new VLNTM plant varieties will provide options for the Company and for potential licensees to more readily comply with the FDA’s plan to dramatically reduce the nicotine in all combustible cigarettes sold in the United States. The non-GMO nature of these tobacco varieties will also facilitate the sale of 22nd Century’s proprietary VLN™ tobacco in some foreign countries where the use of genetically modified crops is restricted.

22nd Century Files 2018 Second Quarter Report | Seeking Alpha

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