22nd Century Now Free of Restrictive License Agreement with British American Tobacco
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 that he 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 thrilled to 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.
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.
22nd Century Group
James Vail, 716-270-1523
Director of Communications
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
GCEL Releases G20 Nations Case Study Involving 90 Ministries, NGOs & IGOs Defining the Guidelines for the Digital Economy Era23.5.2018 18:34 | Pressemelding
GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform (DEP) through GCEL’s HumaWealth Program that digitizes the USD 140 trillion B2B marketplace. These agreements will implement the newly released G20 Nations Case Study recommendations providing the roadmap to reduce annual domestic and international trade costs by USD 3.7 trillion, increase trade by USD 7.7 trillion, create a USD 1 trillion SME fund and generate 300 million manufacturing, agricultural and service industry jobs by 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523006259/en/ GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform in collaboration with the world's leading technology firms to digitize the USD 140 trillion B2B marketplace (Photo: Business Wire) The agreement was signed by Captain Sa
LTI Q4 USD Revenue Growth up 5.3% QoQ and 21.6% YoY; FY18 Revenues of USD1.13bn, up 16.7%; Digital Revenues Grow 42% in FY1823.5.2018 15:04 | Pressemelding
Larsen & Toubro Infotech (BSE: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q4 FY18 and full year FY18 results today. Q4 FY 18 In US Dollars: Revenue at USD 309.0 million; growth of 5.3% QoQ and 21.6% YoY Constant Currency Revenue growth of 4.5% QoQ and 18.7% YoY In Indian Rupees: Revenue at Rs 20,012 million; growth at 6.2% QoQ and 19.3% YoY Net Income at Rs 2,894 million; Net Income growth at 2.3% QoQ and 13.7% YoY Full year FY18 In US Dollars: Revenue at USD 1,132.3 million; growth of 16.7% YoY Constant Currency Revenue growth of 14.7% YoY In Indian Rupees: Revenue at Rs 73,065 million; growth at 12.4% YoY Net Income at Rs 11,124 million; Net Income growth at 14.6% YoY “Our outstanding growth of 5.3% QoQ in Q4 is a result of a broad-based performance across all verticals. We have delivered an industry leading growth of 16.7% for the full financial year with digital revenues up 42% YoY. Our sustained investments in exponential technol
Zebra Medical Vision Announces CE Approval of its Seventh AI Imaging Algorithm - Mammography Lesion Detection23.5.2018 15:00 | Pressemelding
Zebra Medical Vision (http://zebra-med.com/) announces today the CE regulatory approval of its newest algorithm to be included in its growing Deep Learning Imaging Analytics platform. The algorithm, capable of detecting suspected malignant lesions in Mammography scans - is the latest addition to other automated tools announced in the past as part of it’s “All-In-One” AI1 business model, among them algorithms that automatically detect brain bleeds, vertebral fractures, coronary artery disease, osteoporosis and more. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005843/en/ Credit: Zebra Medical Vision According to the American Cancer Society, breast cancer makes up 25% of all new cancer diagnoses in women globally - with nearly 1.7 million women being diagnosed annually. Survival rates, though improving - vary worldwide. In countries with advanced care, the rate is 80 to 90 percent for those with a first-stage diagnosis
Korea's Government-Backed HOOXI Campaign Issues W Green Pay (WGP), First Blockchain Enabled Reward System for GHG Reduction by Individuals23.5.2018 13:00 | Pressemelding
W Green Pay (WGP), the blockchain from HOOXI, Korea's government-backed Greenhouse Gas (GHG) reduction campaign, is taking a different tack at encouraging individuals to reduce GHG. While GHG reduction initiatives have been around, HOOXI is the first to directly reward individuals for reducing GHG. HOOXI introduces the first blockchain to help enable the reward system and facilitate the on-going reward distribution to individuals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005643/en/ Youree Lee (third from left), CEO of W-Foundation, along with campaign ambassadors Korean idol group INFINITE members and Korean government officials, during the HOOXI Campaign Committee Inauguration Ceremony at The National Assembly of Republic of Korea on 26th April 2018. PHOTO: W-FOUNDATION W-Foundation, an international non-profit organization and a designated donation organization entitled by the Ministry of Strategy and Finance o
Nordson EFD Introduces New GV Series Gantry Fluid Dispensing Robot with Vision23.5.2018 12:04 | Pressemelding
Nordson EFD, a Nordson company (NASDAQ: NDSN), the world’s leading precision fluid dispensing systems manufacturer, introduces the vision-guided GV Series automated fluid dispensing gantry robot. Specialized DispenseMotion™ software and an integrated CCD smart vision camera or simple pencil camera make the automated systems quick to set up and easy to program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005033/en/ The new GV Series gantry robot from Nordson EFD is ideal for precision fluid dispensing onto substrates that require large working envelopes with market-leading deposit placement repeatability. (Photo: Business Wire) The CCD camera converts pixels into digital values to deliver precise, high-quality images. The proprietary dispensing software confirms workpiece presence and placement and automatically adjusts as in-process variations occur. “With working envelopes that range from 400 mm to 800 mm and unlim
NITI Aayog and ABB India Partner to Make India AI-Ready23.5.2018 10:30 | Pressemelding
The National Institution for Transforming India (NITI Aayog), the think tank of the Indian government, and ABB India have signed a Statement of Intent (SoI) to support the Indian government to realize its ambitious vision of “Make in India” through advanced manufacturing technologies that incorporate the latest developments in robotics and artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005618/en/ Anna Roy of NITI Aayog and Sanjeev Sharma, managing director of ABB India, sign a statement of partnership in advanced manufacturing technologies, including digital and AI, in New Delhi today. Looking on are Amitabh Kant, CEO of Niti Aayog, and Ulrich Spiesshofer, CEO of ABB (Photo: Business Wire) NITI Aayog will work with ABB to prepare key sectors of the economy, such as the power and water utilities sector, industries like food as well as the heavy industries sector; and the transport (rail and metr