Tag: 22nd Century Group

  • 22nd Century Expands VLN Tobacco Cultivation

    22nd Century Expands VLN Tobacco Cultivation

    Photo: Matt Mullen

    22nd Century Group will significantly expand its growing program for VLN reduced nicotine content tobacco based on the company’s latest sales projections. This new planting for VLN tobacco is in addition to the company’s sizeable inventory of VLN tobacco, which is earmarked for the launch and initial sales of 22nd Century’s VLN reduced nicotine content cigarettes.

    22nd Century’s Modified Risk Tobacco Product (MRTP) application for VLN cigarettes is currently in the final stage of review with the U.S. Food and Drug Administration (FDA). Once authorization is granted, 22nd Century will begin marketing its VLN cigarettes, which contain 95 percent less nicotine than conventional cigarette brands.

    “We are prepared to launch our VLN cigarettes within 90 days after receiving marketing authorization from the FDA,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement. “There are more than 34 million smokers in the United States and research shows that a majority of these smokers are looking for alternatives.”

    22nd Century says it is also interested in licensing its technology other cigarette manufacturers to help them comply with the FDA’s plan to make all cigarettes non-addictive. “We look forward to the tobacco industry joining our efforts to truly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes,” said Mish.

    In partnership with select tobacco farmers, 22nd Century will plant this new VLN tobacco throughout the U.S. tobacco belt. The company’s proprietary, reduced nicotine content tobacco contains, on average, just 0.5 milligrams of nicotine per gram of tobacco, compared with conventional cigarette tobaccos which often contain 20 mg to 30 mg nicotine per gram of tobacco.

    Published in 2017, the FDA’s comprehensive plan for tobacco and nicotine regulation aims to set a product standard for cigarettes that achieves “minimally or non-addictive” levels of nicotine. The FDA projects that within the first year of implementing a mandate, it will help more than five million adult smokers to quit smoking and will save more than eight million American lives by the end of the century.

  • 22nd Century Patent for Cannabis Technology

    22nd Century Patent for Cannabis Technology

    Photo: cytis from Pixabay

    22nd Century Group has been granted a new U.S. patent related to the control of cannabinoid and terpene production in plants. This new intellectual property exclusively provides 22nd Century with unique and powerful tools to alter the cannabinoid biosynthesis pathway in hemp/cannabis plants.

    “We are delighted to receive this patent, which is the result of work carried out by our own scientists. This important, new technology will allow us to genetically modify hemp/cannabis plants to modulate their cannabinoid and terpene profiles in order to tailor these plants’ therapeutic qualities and enhance the consumer’s hemp/cannabis experience,” said Juan Sanchez Tamburrino, vice president of research & development at 22nd Century Group in a statement.

    “Our patent application describes eight promoters, which are essentially molecular on/off switches, covering all of the major steps in the cannabinoid biosynthesis pathway. Typically, developing hemp/cannabis plants with new cannabinoid or terpene profiles could take 10 to 20 years using traditional breeding methods.

    “Now, with the combined technologies and know-how of 22nd Century and KeyGene, we expect to shorten the development timeline to create new, differentiated, hemp/cannabis plant lines in just four to five years. Doing so will provide the company and its potential licensees and customers with significant competitive advantage as hemp/cannabis continues to penetrate the life science, consumer product, and pharmaceutical markets.”

    “At 22nd Century Group, we take a scientific and solutions-oriented approach to advancing ground-breaking, plant-based technology. We are excited to secure this patent, and we believe that it demonstrates our unique and leading role in plant science innovation within the $100 billion global hemp/cannabis market,” said James A. Mish, chief executive officer of 22nd Century Group.

    The new patent, published as U.S. Patent No. 10,787,674 B2 and entitled “Trichome specific promoters for the manipulation of cannabinoids and other compounds in glandular trichomes,” enables 22nd Century to develop and deliver new hemp/cannabis plants that are designed to produce cannabinoids more efficiently.

    The company can potentially increase the yield of plants, stabilize the level of cannabinoids that are produced, and create custom cannabinoid profiles optimized for specific therapeutic uses. 22nd Century will also be able to potentially modulate the terpene levels within the plant—increasing them to deliver new strains of cannabis for the adult-use/recreational market and reducing them to remove the odor and taste for improved application in foods and beverages.

    Cannabinoids, such as CBD, CBC, and CBG, are valuable compounds that hold great promise for the development of new medicines and other therapeutic applications. Cannabis sativa is the only plant species that produces significant amounts of these compounds including more than one hundred different cannabinoids in varying quantities.

    In nature, cannabis plants restrict production of these potentially toxic compounds to the trichomes which are tiny hair-like stems and globes that grow on the surface of the plant. To successfully manipulate cannabinoids, the company’s new technology activates molecular promoters, “on/off switches,” specifically and only in the plant’s trichomes where the majority of cannabinoids are produced.

    These regulatory sequences dynamically enhance or restrict gene expression levels, controlling the expression of genetic information that leads to the production of cannabinoids.

  • FDA Orders Spectrum Research Cigarettes

    FDA Orders Spectrum Research Cigarettes

    Photo: Simone van den Berg | Dreamstime

    The U.S. Food and Drug Administration (FDA) in coordination with the National Institute on Drug Abuse and other organizations, has ordered 3.6 million Spectrum-brand variable nicotine research cigarettes from 22nd Century Group.

    The research cigarettes will be used for independent, scientific studies to validate the public health benefits identified by the FDA and others of implementing a national standard requiring all cigarettes to contain minimally or non-addictive levels of nicotine.

    “We are proud to partner with public health researchers and look forward to the next step in the FDA’s plan to reduce the nicotine content of all cigarettes sold in the U.S. to minimally or non-addictive levels,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.

    “22nd Century remains the leader in reduced nicotine content tobacco products. We believe when the FDA mandate ultimately goes into effect, we will be well-positioned to capitalize on this tremendous opportunity, and we are committed to licensing our technology to make it possible for every cigarette manufacturer in the U.S. to comply with the standard.”

    According to 22nd Century Group, the selection of Spectrum cigarettes is not connected to 22nd Century’s modified risk tobacco application for the company’s reduced nicotine content VLN cigarettes, which feature 95 percent les nicotine than conventional brands.

    22nd Century believes that authorization of the company’s MRTP application is imminent, and it plans to launch VLN cigarettes within 90 days of authorization.

  • FDA Urged to Mandate Minimal Nicotine

    FDA Urged to Mandate Minimal Nicotine

    Photo: Martinmark – Dreamstime.com

    John Pritchard, 22nd Century’s vice president of regulatory science, has called on the U.S. Food and Drug Administration (FDA) to accelerate implementation of its comprehensive plan on tobacco and nicotine regulation, in particular to impose the mandate requiring all cigarettes sold in the United States to contain minimally or non-addictive levels of nicotine.

    The proposed rule was removed from the agency’s agenda late last year without significant explanation.

    “Despite the obvious harm of smoking, the staggering public health costs, and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster, Pritchard wrote in a newsletter published by the global data intelligence company Morning Consult.

    “This is the perfect time to take that step.”

    22nd Century has invested heavily in nicotine-reduction technology, and the company stands to benefit greatly if the FDA mandates minimally addictive levels of nicotine.

    “Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes,” Pritchard wrote.

    “Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States

  • Patent Granted for Nicotine Reduction

    Patent Granted for Nicotine Reduction

    Photo: Tobacco Reporter archive

    22nd Century Group has been granted a new U.S. patent related to the reduction of nicotine in the tobacco plant. The new technology provides 22nd Century with a rapid pathway to introduce very low nicotine traits into virtually any variety of tobacco, including bright, burley, oriental, and cigar tobacco varieties.

    “We are very pleased to receive this patent which reflects the ingenuity and expertise of our talented scientific team,” said James A. Mish, chief executive officer of 22nd Century Group in a statement. “This new technology allows us to reduce nicotine in any tobacco variety.

    “Importantly, this breakthrough further demonstrates that the FDA’s comprehensive plan for tobacco and nicotine regulation to limit the nicotine content of all cigarettes sold in the United States is technically feasible and at the same time refutes the claim from Big Tobacco that such low nicotine levels cannot be achieved in multiple tobacco varieties,” he added.

    “I am proud of the significant R&D gains we continue to make as we work to achieve our mission to reduce the harm caused by smoking and seek to significantly disrupt the $100 billion U.S. and the $800 billion global tobacco industries with our proprietary reduced nicotine tobacco products.”

    The new patent and allowed claims, published as U.S. Patent No. 10,669,552 and entitled “Up-regulation of auxin response factor NbTF7 to decrease nicotine in a plant,” cover methods of manipulating plant metabolism and alkaloid levels by controlling transcription factor NbTF7, which regulates the nicotinic alkaloid biosynthetic pathway. The patent enables the company’s use of next-generation gene modification technologies that afford greater flexibility for genetic control over nicotine levels in virtually any variety of the tobacco plant.

    22nd Century is preparing for the launch of VLN, its proprietary reduced nicotine content tobacco cigarettes containing 95 percent less nicotine than conventional counterparts. Pending the FDA’s authorization of the company’s Modified Risk Tobacco Product (MRTP) application, VLN would be the first and only combustible cigarette to receive a MRTP designation, according to 22nd Century.

     

  • 22nd Century Anticipates MRTP

    22nd Century Anticipates MRTP

    Photo: Myriam Zilles from Pixabay

    22nd Century Group plans to commercialize its VLN cigarette plan within 90 days of receiving a modified-risk tobacco product (MRTP) application.

    In a letter to shareholders, group CEO James A. Mish expressed optimism that the company’s VLN brand, which contains 95 percent less nicotine than other leading cigarette brands, would be granted MRTP status by the U.S. Food and Drug Administration (FDA).

    In March 2018, the FDA issued “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” an advance notice of proposed rulemaking seeking public comment for consideration in developing a potential nicotine product standard.

    “We now believe it is not a matter of if but when our application will be granted, and we believe we are months, not years, away from securing our MRTP designation,” wrote Mish.

    Mish suggested that an MRTP would greatly boost 22nd Century’s market value.

    “Having the only combustible cigarette with a modified exposure claim authorized by the FDA […], could serve as a catalyst for 22nd Century’s commercial sales as even achieving just one-quarter of 1 percent—0.25 percent—market share of the U.S. tobacco market could result in revenues that may over time, based on current market multiples, drive the company’s market capitalization more than five to 10 times higher than it is today,” he said.

    “In addition, FDA authorizing the marketing of 22nd Century’s modified risk tobacco products with modified exposure claims would open multiple licensing opportunities for 22nd Century’s proprietary reduced nicotine content tobacco to accelerate the commercial and public health potential.”

  • Michael Koganov Joins 22nd Century Board

    Michael Koganov Joins 22nd Century Board

    Michael Koganov

    22nd Century Group has appointed Michael Koganov to its board of directors. Koganov will serve as chair of the company’s scientific and technical advisory committee and as a member of its finance committee.

    Koganov is recognized as a leading expert in the development of natural products using plant biotechnology and has achieved considerable accomplishments in physico-chemistry, biochemistry, bioelectrochemistry and biotechnology.

    Among other things, he is credited with developing electro-membrane technology for the comprehensive processing of plants to produce protein concentrates and secondary metabolites. Koganov co-founded IBT, which developed the proprietary and sustainable Zeta Fraction technology.

    “We are excited to welcome Michael to our board,” said 22nd Century’s board chair, Nora Sullivan in a statement. “As a recognized expert in plant biotechnology and life science, Michael will further strengthen our leadership team with his highly relevant expertise related to the Company’s strategic, scientific initiatives.”

  • Revenues up for 22nd Century Group

    Revenues up for 22nd Century Group

    Image by Steve Buissinne from Pixabay

    22nd Century Group saw a net sales revenue increase of 12 percent, or $0.8 million, in the first quarter of 2020 over last year.

    The company suffered an operating loss of $4.1 million compared to $5.4 million in 2019.

    “We are very pleased with the solid start to 2020, with revenue increasing 12 percent over last year,” said Mike Zercher, president and chief operating officer of 22nd Century. “We believe the company is well positioned to execute on its strategies despite a challenging backdrop due to Covid-19. Our manufacturing facility has remained open and has been able to fulfill orders without any backlog. The improvements we made to our cost structure in 2019 have started to pay off in the first quarter with a 16 percent reduction in operating expenses compared to the same quarter last year.

    “Additionally, the U.S. Food and Drug Administration (FDA) recently announced a deadline for public comments on the company’s modified-risk tobacco product (MRTP) application. This moves our MRTP application one step closer to an FDA authorization decision for the company’s proprietary reduced nicotine content tobacco cigarettes. Bringing these products to market is an important and exciting prospect for the company and public health,” Zercher added.

  • Non-GMO low nicotine

    Non-GMO low nicotine

     

    22nd Century Group and North Carolina State University have developed several new very-low-nicotine (VLN) tobacco varieties that contain no foreign DNA and no trace of genetic modification.

    The new varieties are suited for use in the 22nd Century’s X-22 smoking-cessation product in development and will also form the basis of other 22nd Century VLN products.

    The absence of foreign DNA or traces of genetic modification means the VLN varieties will not be subject to burdensome regulations and import restrictions on GMO products in many countries.

    22nd Century is in contact with marketers and distributors in Japan, India and Korea to facilitate the import of products based on the company’s new tobaccos.

    According to the company, the new VLN tobacco varieties exhibit improved ripening and curing qualities. 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 is based on one of the most widely grown air-cured burley tobaccos, which has excellent disease resistance and yield potential.

    “We are absolutely delighted that we have achieved our goal of producing non-GMO very-low-nicotine tobacco,” said 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.”

    “We are extremely pleased that our project with 22nd Century has been such a success,” said Ralph Dewey, the principal investigator at North Carolina State University.

    “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.”

    22nd Century Group is a plant biotechnology company focused on tobacco harm reduction and cannabis research.

     

     

     

     

     

  • 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.”