CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company focused on tobacco harm reduction and hemp/cannabis research, announced today that the Company shipped 2.4 million SPECTRUM® research cigarettes for the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH).
As a subcontractor under federal government contracts, 22nd Century has supplied the Company’s proprietary SPECTRUM® research cigarettes for NIDA since 2011. The SPECTRUM® product line consists of a series of 24 cigarette styles (11 regular and 13 menthol versions) that have 8 different levels of nicotine – from very low to high.
The U.S. Food and Drug Administration (FDA) and other agencies of the U.S. federal government have invested more than $100 million in numerous independent clinical studies that have demonstrated the public health benefits of 22nd Century’s proprietary Very Low Nicotine Content (VLNC) tobacco cigarettes. As a result of this research, scientists have found that VLNC cigarettes reduce cravings, reduce consumption of cigarettes, and increase quit attempts.
A seminal study was recently completed with 22nd Century’s SPECTRUM® research cigarettes. This independent Phase III study featured 1,250 participants at 10 study locations, including the Mayo Clinic, the Johns Hopkins University, Duke University, the University of Texas MD Anderson Cancer Center, the University of Pittsburgh, the University of Minnesota, the University of Vermont, the University of California – San Francisco and others, all in collaboration with NIDA. The completed Phase III study compared two different approaches to help smokers lose their addiction to nicotine: 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. Although the results of this highly anticipated clinical trial are still in peer review prior to being published, a principal investigator in the trial, Dr. Dorothy Hatsukami, has already publicly disclosed that an immediate reduction in nicotine is “most likely to lead to less harm.” This announcement came only weeks after the FDA announced that the Agency 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’s SPECTRUM cigarettes have facilitated dozens of independent studies that have demonstrated, conclusively, the public health benefits of minimally or non-addictive cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “What’s more, 22nd Century’s proprietary Very Low Nicotine cigarettes show that the FDA’s plan to mandate dramatically reduced nicotine levels in cigarettes is immediately feasible. We are proud to be a part of this exceptionally important public health initiative.”
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 hemp/cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/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.
