TI JanFeb2016 • TPI Q1

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JANUARY/FEBRUARY 2016 TOBACCO INTERNATIONAL 19 T h e 2 2 n d C e n t u r y G r o u p ( o r XXII Century Group) is a plant biotechnology company with a mission to reduce the harm caused by smoking. This is a bold endeavor, and XXII intends to succeed by focusing on technology that allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The company comes at this in two distinct ways. On one hand, XXII Century products encourage gradual cessation through the use of Very Low Nicotine tobacco. On the other hand, the company encourages less exposure to tar and smoking through the use of high nicotine p r o d u c t s t h a t d e l i v e r a s t r o n g e r nicotine profile per-cigarette—so by smoking fewer cigarettes, smokers of XXII's high nicotine product are being encouraged to do less actual smoking. U n d e r C E O H e n r y S i c i g n a n o III, we are now seeing something of a turn of the century, with XXII transitioning from an early R&D- focus to the commercialization of its proprietary technology and products. Its long-term strategy is evolving to embrace the licensing, manufacturing and selling of its tobacco. With more than 15 years of experience within the tobacco industry, Sicignano views the combined worldwide sales of tobacco products ($800B, primarily cigarettes) and the $1B US cessation market, as well as the $3B global smoking cessation market, which may grow as large as $5B by 2020, to be the pathways to success for XXII. Through the wholly-owned XXII subsidiaries, G o o d r i c h T o b a c c o C o m p a n y a n d Hercules Pharmaceuticals, Sicignano and his team are focused on certain key goals—the sales and distribution of their premium cigarette brands, achieving FDA approval for XXII's p o t e n t i a l l y l e s s h a r m f u l t o b a c c o c i g a r e t t e s , a n d d e v e l o p i n g t h e i r virtually nicotine-free cigarette, X-22, as a smoking cessation aid. We reached out to Sicignano and asked him how the commercialization process was going and whether he was happy with the pace of developments. "This promises to be a break-out year for 22nd Century," Sicignano told Tobacco International. "In 2016, it is likely the company will announce a strategic partner to fund Phase III clinical trials for its smoking cessation p r o d u c t , X - 2 2 . I n a d d i t i o n , t h e company expects to receive approval from the FDA to market its Very Low Nicotine commercial product, BRAND A, in the United States. And 22nd Century plans to expand distribution of MAGIC Very Low Nicotine cigarettes in Europe from its current availability in Spain to include also Holland, the UK, France and Italy. We are very excited about our accomplishments and look forward to even greater results ahead." Sicignano said that he had set a number of goals, some for the end of 2016, and others going out five years. "The 2016 commercial goals for the company are as follows," Sicignano said. "One, secure an FDA marketing o r d e r f o r B R A N D A , V e r y L o w Nicotine reduced exposure cigarettes in the United States. Two, announce a s t r a t e g i c p a r t n e r f o r P h a s e I I I clinical trials in support of X-22, the company's smoking cessation product. And three, grow sales and profits for 22nd Century. Well within the next five years, the company plans to one, launch BRAND A in the United States. Two, submit a Modified Risk Tobacco Products application to the FDA for BRAND B, low tar-to-nicotine ratio c i g a r e t t e s . T h r e e , a p p l y f o r F D A approval for X-22, the company's smoking cessation product and launch X-22 in the United States. And four, introduce 22nd Century's proprietary tobacco products in Asia. Achieving any one or more of these important goals will transform 22nd Century into a true industry leader as it helps millions of people around the world reduce the harm caused by smoking." Among XXII's proprietary products is Very Low Nicotine tobacco and we asked Sicignano to share how this variety came to be and to describe some of the challenges and milestones in its development. "Very Low Nicotine tobacco—with TURN OF THE XXII CENTURY The Turn of the Century Tobacco's XXII Century Group CEO Henry Sicignano III Commercializes Proprietary Tobacco Technology and Reduces Harm from Smoking –By Murdoch McBride Henry Sicignano, III, president and chief executive officer of the XXII Century Group

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