Tag: 22nd Century Group

  • Greenbutts to Produce at 22nd Century

    Greenbutts to Produce at 22nd Century

    Photo: Greenbutts

    22nd Century Group will provide Greenbutts with manufacturing space at its Mocksville, North Carolina, USA, NASCO manufacturing facility and with NASCO staff to operate the equipment for a new cigarette filter solution.

    Greenbutts offers a patented technology to replace single-use, plastic-based filters currently used in tobacco products with water-soluble, fully biodegradable filter solutions.

    “With an estimated 6 trillion manufactured every year, plastic-based cigarette butts are the most abundant form of plastic waste worldwide,” said 22nd Century Group chairman and CEO Larry Firestone in a statement.

    “Adding to that, an estimated 65 percent are littered, making them the world’s single most littered item. Unfortunately, the cellulose acetate plastics used in conventional cigarette butts takes decades to biodegrade, resulting in toxic waste that is harmful to ecosystems and wildlife, especially aquatic ecosystems. Greenbutts provides a simple, nontoxic, 100 percent biodegradable, plant-based and water-dispersing solution that is free of plastic and harmful chemicals while providing the same smoking experience as current filters.

    “Under this new multiyear agreement, 22nd Century Group will provide the manufacturing space and support needed to produce sample product to allow Greenbutts to pursue FDA approval, with the mutual goal thereafter of expanding to full commercial production.

    “We see this as an exciting new innovation and disruptor that could be used in both our VLN reduced-nicotine content cigarettes, the first and only combustible cigarette to receive an FDA harm reduction authorization, and in our CMO business for other conventional cigarette brands as well, where advanced discussions about potential use in cigarette products are already underway.”

  • 22nd Century Expands Nicotine-Reduction IP

    22nd Century Expands Nicotine-Reduction IP

    Photo: Tobacco Reporter archive

    22nd Century Group has signed a reduced nicotine content technology license with North Carolina State University. The latest license provides additional modes of efficiently producing reduced nicotine content tobacco plants, extending 22nd Century’s IP portfolio. The license will provide 22nd Century Group exclusive rights to the technology until 2042.

    “Our reduced nicotine content technologies support the first and only FDA MRTP [modified-risk tobacco product] authorized combustible smoking harm reduction products that meet adult smokers where they are today, providing a new solution to help them smoke less and achieve their health goals,” said 22nd Century Group interim CEO John Miller in a statement.

    “This latest license further enhances and expands on our capabilities to produce reduced nicotine content tobacco plants as we work to bring these innovative products to market for the betterment of public health, including by enhancing our capability to produce reduced nicotine content tobacco plants suitable for international markets that are opposed to genetically modified plants.”

    This latest license further enhances and expands on our capabilities to produce reduced nicotine content tobacco plants.

    John Miller, interim CEO, 22nd Century Group

    Under terms of the exclusive license, 22nd Century will have full use of the patent rights and plant materials to develop and commercialize reduced nicotine content tobacco using this latest non-GMO technology, which further enables worldwide marketability of the company’s VLN reduced nicotine content products.

    “22nd Century is pioneering a new pathway in the global fight to end the health and economic harms of smoking, offering both GMO and non-GMO solutions suitable worldwide,” said Miller. “Extensive clinical research, much of it funded by national government health agencies, has consistently documented the benefit of reduced nicotine content tobacco products in helping adult smokers to break the bonds of nicotine addiction and smoke less over time. Reduced nicotine content solutions, such as our VLN products, provide a new solution to adult smokers who want to quit, but have not found success with traditional cessation products.”

  • 22nd Century Names New CEO

    22nd Century Names New CEO

    Photo: Jakub Jirsák | Dreamstime.com

    22nd Century Group has appointed James A. Mish to the position of CEO effective June 22, 2020. John Franzino has been named chief financial officer effective immediately.

    Mish brings extensive global executive leadership experience in science-driven organizations with a recent focus on the development, manufacturing and commercialization of active pharmaceutical ingredients (API).

    Prior to joining 22nd Century, Mish served as CEO of Noramco, a producer of controlled substances for the pharmaceutical industry, and Purisys, a synthetic cannabinoid API ingredients and solutions provider to pharmaceutical and consumer products companies. Mish led the creation and spinoff of Purisys from Noramco during his tenure.

    Prior to joining 22nd Century Group, Franzino served as chief financial officer of the West Point Association of Graduates. Additionally, he has extensive strategic financial leadership experience serving as vice president of finance and controller at Bard College; as chief financial officer of Santa Fe Natural Tobacco Company; and as chief financial officer of Labatt USA.

    “We are very pleased to welcome Jim as our new Chief Executive Officer at this critical juncture in our Company’s history,” said Nora B. Sullivan, chairperson of the board of directors of 22nd Century. “We are also pleased to welcome John Franzino into the role of chief financial officer.”
     

  • 22nd Century to open new laboratories

    22nd Century Group, a plant biotechnology company and leader in tobacco harm reduction, has announced that it will open specialized laboratories in western New York, USA, dedicated to new scientific research at substantially lower costs than sponsored research projects at third-party universities.

    Paul J. Rushton, Ph.D., the company’s vice president of plant biotechnology, will lead the new scientific initiative. The laboratories will accelerate the development of new nicotine-free tobacco varieties as well as the invention of important tobacco products.

    “This is a very exciting time for our company,” said Rushton. “Our new laboratories will provide 22nd Century with the in-house capabilities to rapidly expand our genomics-based research and to accelerate commercialization of our technologies.”

     

  • 22nd Century settles litigation with former CEO

    22nd Century Group, a leader in tobacco harm reduction, announced Nov. 9 that the company and its former CEO and founder, Joseph Pandolfino, have settled all litigation and disputes between the parties.

    “As the founder of 22nd Century and as a major stockholder, Joe’s interests are closely aligned with those of other shareholders,” Henry Sicignano III, 22nd Century’s CEO and president stated in a press release. “We look forward to Joe’s helpful input going forward as a strategic consultant who will be tasked with assisting 22nd Century on special projects such as commercialization of Red Sun, Magic and our extraordinary modified risk tobacco products in development: ‘Brand A’ and ‘Brand B.’”

    Joseph Pandolfino said, “I am thrilled that all disagreements between me and the company have been resolved. As a strategic consultant, I look forward to working with Henry and the team to create shareholder value. 22nd Century is a unique company with an important public health mission and I remain dedicated to its success.”

    The details of the settlement have been disclosed by the 22nd Century in its filing with the U.S. Securities and Exchange Commission (SEC) of a current report on Form 8-K, which is publicly available on the SEC’s EDGAR database on the SEC website, www.sec.gov.

  • 22nd Century to partner with Anandia for cannabis research

    22nd Century Group, a leader in tobacco harm reduction, has entered into a new cannabis research collaboration with Anandia Laboratories.

    As a part of this research collaboration, Vancouver, Canada-based Anandia Laboratories will develop and grow cannabis strains that express highly desirable characteristics and will lead to potential commercialization opportunities. The initial focus of the collaboration will include cannabinoid-free cannabis for the commercial hemp industry and high levels of non-THC cannabinoids, such as CBD, for legal medical marijuana markets.

    Dr. Paul Rushton, 22nd Century’s new vice president of plant biotechnology, will have responsibility for the company’s partnership with Anandia Laboratories.

  • Landmark study uses 22nd Century’s low-nicotine cigarettes

    The New England Journal of Medicine (NEJM) has published an article detailing a landmark study that used low-nicotine Spectrum cigarettes produced by 22nd Century, a leader in tobacco harm reduction.

    The double-blind, parallel, randomized clinical trial was led by the Center for the Evaluation of Nicotine in Cigarettes and involved 840 smokers at 10 locations. Funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, the study included six styles of 22nd Century’s Spectrum research cigarettes.

    The 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 percent less nicotine than conventional cigarettes, according to 22nd Century, which claims to be the only company in the world capable of growing tobacco with such low nicotine content.

    The authors concluded that data from the study suggests 22nd Century’s 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.”

    Researchers found that during the sixth and final week of the trial, participants who were assigned Spectrum cigarettes with 0.4 mg/g nicotine smoked fewer cigarettes per day (14.9) than those who were assigned to their usual brand of cigarettes (22.2). In addition, 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. In the 30 days following the trial, smokers of very low nicotine cigarettes reported that they attempted to quit smoking at a rate double that of participants who smoked cigarettes with 15.8 mg/gram nicotine (34.7 percent compared to 17 percent).

    “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,” Dr. Eric Donny, the study’s lead author, was quoted as saying in article posted on www.usatoday.com.

    To further test that theory, Spectrum cigarettes are being used in a phase III clinical study that follows 1,250 smokers for five months.

    The results of previous studies using very low nicotine cigarettes have demonstrated a variety 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, which reduce nicotine yields by diluting the smoke rather than by reducing the nicotine content of tobacco, very low nicotine cigarettes do not result in compensatory smoking.

    “The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy … ” public health policy reform advocates Drs. Michael Fiore and Timothy Baker explained in a separate article published in 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.”

  • Gellman to facilitate 22nd Century’s FDA applications

    22nd Century Group, a leader in tobacco harm reduction, has appointed Gregg M. Gellman as the company’s director of business development and regulatory affairs. Gellman, who was hired for his experience in achieving U.S. Food and Drug Administration compliance approval for various types of products, will be tasked with driving 22nd Century’s regulatory affairs strategies for the company’s two modified risk cigarettes in development: “Brand A,” the world’s lowest nicotine tobacco cigarette, and “Brand B,” the world’s lowest tar-to-nicotine ratio cigarette.