22nd Century Group, Inc. operates as a plant biotechnology company. The company focuses on tobacco harm reduction and smoking cessation products produced from modifying the nicotine content in tobacco plants through genetic engineering and plant breeding. Business The company is primarily involved in the following activities: the international licensing of the company’s technology, proprietary tobaccos, and trademarks; the manufacture, marketing and international distribution of RED SUN and MAGIC proprietary cigarettes; the production of SPECTRUM research cigarettes for the National Institute on Drug Abuse (NIDA); the research and development of potentially reduced-risk or modified risk tobacco products; the development of X-22, a prescription-based smoking cessation aid consisting of very low nicotine (VLN) cigarettes; and the pursuit of necessary regulatory approvals and clearances from the U.S. Food and Drug Administration (FDA) to market in the U.S X-22 as a prescription smoking cessation aid and BRAND A and BRAND B as reduced-risk or Modified Risk Cigarettes. Goodrich Tobacco Company, LLC (Goodrich Tobacco) and Hercules Pharmaceuticals, LLC (Hercules Pharmaceuticals) are subsidiaries of the company. Goodrich Tobacco is focused on commercial tobacco products and potentially reduced-risk or modified risk tobacco products. Hercules Pharmaceuticals is focused on X-22, a prescription smoking cessation aid in development. The X-22 therapy protocol utilized in its sponsored Phase II-B 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. Goodrich Tobacco, introduced two cigarette brands, RED SUN and MAGIC, into the U.S. market in 2011. Both brands are available in regular and menthol and all brand styles are king size and packaged in hinge-lid hard packs. SPECTRUM Government Research Cigarettes The company was chosen to be a subcontractor for a government contract between RTI International (RTI) and the National Institute on Drug Abuse (NIDA) to supply altered nicotine research cigarettes (from very low to high) cigarettes to NIDA. These government research cigarettes are distributed to researchers free of charge under the mark SPECTRUM. Strategy The company’s long-term focus is the research, development, licensing, manufacturing, and worldwide sales and distribution of its products to reduce the harm caused by smoking. Intellectual Property The company controls 114 issued patents and an additional 38 patent applications; of these, the company owns 13 issued patents plus 25 patent applications and the company licenses the remaining patents and patent applications on an exclusive basis. The company’s patent coverage in the United States and China, 2 of the smoking cessation and cigarette markets worldwide, consisting of 16 issued patents and 8 pending applications and 6 issued patents and 3 pending patent applications, respectively. The company has exclusive rights to all uses of the following genes responsible for nicotine content in tobacco plants: NBB, QPT, A622, MPO and other transcription factor genes. The company owns various registered trademarks in the United States. The company also has exclusive plant variety rights in the United States (plant variety protection certificates are issued by the U.S. Department of Agriculture) and Canada. Competition In the market for FDA-approved smoking cessation aids, the company’s principal competitors are as follows: Pfizer Inc.; GlaxoSmithKline PLC; Novartis International AG; and Perrigo Company plc. Domestic competitors include Philip Morris USA; Reynolds American Inc.; Lorillard Inc.; Commonwealth Brands, Inc.; Liggett Group LCC; and Vector Tobacco Inc. Its international competitors include Philip Morris International, Inc.; Japan Tobacco Inc.; Imperial Tobacco Group plc; and other regional and local tobacco companies. The company also competes with, government-owned tobacco enterprises, such as the China National Tobacco Corporation. 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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