22nd Century Delivers 4.95 Million SPECTRUM® Cigarettes for the National Institute on Drug Abuse

Phase III study already underway examines different uses of 22nd Century’s SPECTRUM® Very Low Nicotine cigarettes to break smokers’ addiction to nicotine

CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the Company shipped 4.95 million SPECTRUM® research cigarettes for the National Institute on Drug Abuse (NIDA), a department of the National Institutes of Health (NIH).

As the only company in the world capable of producing Very Low Nicotine (VLN) tobacco products, 22nd Century was chosen by NIDA to supply its proprietary cigarettes as a subcontractor under a federal government contract. The main SPECTRUM® product line consists of a series of cigarette styles that have a fixed “tar” yield but varying nicotine yields over a 50-fold range – from very low to high. Altogether, SPECTRUM® features 24 styles, 11 regular and 13 menthol versions, with 8 different levels of nicotine content. SPECTRUM® is strictly for research purposes and is not sold as a commercial cigarette.

The available scientific literature, gained in part through independent clinical trials utilizing SPECTRUM® research cigarettes, shows that smoking 22nd Century’s VLN cigarettes results in reduced nicotine exposure with minimal compensatory smoking behavior and no greater exposure to harmful or potentially harmful toxicants.

New clinical trials using 22nd Century’s SPECTRUM® cigarettes are already underway. Most notably, a Phase III study featuring 1,250 participants and sponsored by the University of Pittsburgh, in collaboration with the National Institute on Drug Abuse (NIDA) is comparing 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.

“22nd Century has now delivered over 22 million SPECTRUM® research cigarettes for the National Institute on Drug Abuse,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We are proud to be a part of such important public health research efforts and we are pleased that there is growing support for a national nicotine policy that will give consumers a Very Low Nicotine cigarette choice.”

Without SPECTRUM® cigarettes, many important research projects investigating the exposure and behavioral effects of different nicotine levels in cigarettes would simply be impossible to conduct. Most recently, SPECTRUM® cigarettes were an integral part of the study conducted by Eric C. Donny, Ph.D., et al and the Center for the Evaluation of Nicotine in Cigarettes and published in The New England Journal of Medicine (N Engl J Med 2015; 373:1340-1349). In this study, researchers determined that SPECTRUM®’s Very Low Nicotine style 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. Moreover, in the 30 days following the trial, smokers of SPECTRUM®’s very low nicotine style cigarettes reported they attempted to quit smoking at a rate double that of participants who smoked standard nicotine style cigarettes (34.7% vs. 17%).

22nd Century cited the Donny trial, in addition to extensive data gathered from several other independent clinical trials, in the Company’s recently submitted Modified Risk Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA). 22nd Century’s MRTP application seeks a reduced exposure order so that 22nd Century’s “BRAND A” Very Low Nicotine cigarettes may be introduced into commerce in the United States. The Company’s application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.

At present, the United States is completely devoid of any “reduced exposure cigarette” option. If 22nd Century’s application to the FDA is successful, the Company’s Very Low Nicotine cigarettes will offer millions of American smokers the first reduced exposure cigarette choice.

About 22nd Century Group, Inc.

22nd Century Group 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. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. 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, 2014, filed on February 5, 2015, 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.

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399

Source: 22nd Century Group, Inc.