22nd Century Group, Inc. operates as a plant biotechnology company focused on technology that allows it to increase or decrease the level of nicotine and other nicotinic alkaloids in tobacco plants and levels of cannabinoids in cannabis plants through genetic engineering and plant breeding. The company engages in the licensing and/or sale of its proprietary tobacco, technology and products; domestic and international sales of its brands, including RED SUN and MAGIC; further development of its potential modified risk tobacco products and its X-22 smoking cessation aid; and the manufacture of the filtered cigar and cigarette brands of third-parties at its manufacturing facility in North Carolina. Products RED SUN and MAGIC Cigarettes: The company’s subsidiary, Goodrich Tobacco Company, LLC (Goodrich Tobacco), introduced in a limited capacity two super-premium priced cigarette brands, RED SUN and MAGIC, into the U.S. market in 2011. Both of the RED SUN and MAGIC brands are available in regular and menthol, and all brand styles are king size and packaged in hinge-lid hard packs. In 2015, the company focused its marketing and sales efforts for RED SUN on independent retailers, tobacconists, smokeshops and other tobacco outlets in the U.S. SPECTRUM Government Research Cigarettes: In 2014, Goodrich Tobacco entered into a teaming agreement with RTI International (RTI) to work together to respond to a new request from National Institute on Drug Abuse (NIDA) for the potential purchase by NIDA from RTI of additional SPECTRUM research cigarettes to be produced and sold by Goodrich Tobacco to RTI. BRAND A and BRAND B: The tobacco in BRAND A contains approximately 95% less nicotine than conventional cigarette brands. Using a proprietary high nicotine tobacco blend in conjunction with specialty cigarette components, BRAND B allows the smoker to achieve a satisfactory amount of nicotine per cigarette while inhaling less ‘tar’ and carbon monoxide. X-22 Smoking Cessation Aid: X-22 is a tobacco-based botanical medical product for use as an aid to smoking cessation. The X-22 therapy protocol utilized in its sponsored Phase IIb clinical trial calls for the patient to smoke its very low nicotine (VLN) cigarettes over a six-week treatment period to facilitate the goal of the patient quitting smoking by the end of the treatment period. The company’s Investigational New Drug Application for X-22, a kit of VLN cigarettes, was cleared by the U.S. Food and Drug Administration (FDA) in 2011 and has been updated annually. Research and Development During the year ended December 31, 2015, the company incurred total research and development expenses of approximately $1,669,387. Intellectual Property The company owns or exclusively controls approximately 200 issued patents and approximately 50 pending patent applications. Its patent coverage in the United States and China consists of 27 issued patents and 21 pending applications and 6 issued patents and 6 pending patent applications, respectively. The company has exclusive rights to all uses of the genes responsible for nicotine content in tobacco plants, including NBB, QPT, A622, MPO and various transcription factor genes. Competition In the market for FDA-approved smoking cessation aids, the company’s principal competitors include Pfizer Inc.; GlaxoSmithKline plc; Novartis International AG; and Perrigo Company plc. The company’s domestic competitors include Philip Morris USA; Reynolds American Inc.; Commonwealth Brands, Inc.; Liggett Group LLC; and Vector Tobacco Inc. Its international competitors include Philip Morris International, Inc.; Japan Tobacco Inc.; and Imperial Tobacco Group plc. History 22nd Century Group, Inc. was founded in 1998.
22nd century group inc (XXII:NYSE Amex)
9530 Main Street
Clarence, NY 14031
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