“At the Society for Research on Nicotine (SRNT) Annual Meeting held in Chicago in March of this year, the Company received numerous requests for variable nicotine-level research cigarettes from domestic and international scientists wishing to conduct nicotine addictive threshold and smoking cessation studies. 22nd Century is eager to provide scientists all over the world with the means to conduct their important smoking research,” explained Dr. Paul Rushton, Vice President of Plant Biotechnology at 22nd Century Group.
22nd Century custom designs and produces research cigarettes with precise tobacco blends, nicotine contents, filtration, tar yields, and even custom taste characteristics for each clinical study according to the exact specifications required by scientific researchers. With an approved blend and packaging design, 22nd Century can design, produce and ship research cigarettes in a matter of weeks, thus speeding up the often lengthy and cumbersome process researchers currently endure in order to study behaviors and health risks associated with the use of tobacco products.
In addition to the significant revenue potential of this initiative, the Company anticipates that the research generated through the use of 22nd Century’s Very Low Nicotine research cigarettes will add to the growing number of peer-reviewed scientific studies that demonstrate the public health benefits of 22nd Century’s proprietary tobaccos. Such independent studies formed the backbone of 22nd Century’s December 2015 Modified Risk Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA). Indeed, many such scientific studies employing the Company’s research cigarettes with varying levels of nicotine are funded by the FDA itself, including the landmark Eric C. Donny, Ph.D. et al. clinical study that was published in the October 2015 issue of The New England Journal of Medicine (N Engl J Med 2015; 373:1340-1349). The FDA is also currently funding – at a cost estimated to exceed $20 million – a follow-up clinical study seeking the best method to quit smoking: an immediate reduction in nicotine to non-addictive levels versus a gradual reduction in nicotine (ClinicalTrials.gov NCT02139930). No matter which protocol proves most effective, 22nd Century is the only company in the world capable of producing the critical final product: combustible tobacco cigarettes with non-addictive levels of nicotine.
“Without 22nd Century’s unique ability to provide research cigarettes with varying nicotine levels, many important research projects would simply be impossible to conduct,” explained Henry Sicignano III, the Company’s President and Chief Executive Officer. “Accordingly, due to the increasing demand for our SPECTRUM® research cigarettes, we felt compelled to make similar research cigarettes available directly to scientists around the globe. What’s more, unlike SPECTRUM® cigarettes, 22nd Century’s new research cigarettes will be available in any configuration and in any style requested by researchers. We expect this new product line to grow rapidly.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.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, 2015, filed on February 18, 2016, 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.