TOBACCO INTERNATIONAL

TI JanFeb2016 • TPI Q1

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26 TOBACCO INTERNATIONAL JANUARY/FEBRUARY 2016 while pursuing other pharmacological goals with tobacco is laudable, Dr. Rushton's focus will be on broadening the company's tobacco technologies and cannabis technologies. The company shall 'stick to its knitting…' " D r . R u s h t o n ' s p r i o r i t i e s a r e as follows: One, together with the c o m p a n y ' s d i r e c t o r o f r e g u l a t o r y affairs, Gregg Gellman, Dr. Rushton w i l l s h e p h e r d o u r M o d i f i e d R i s k Tobacco Products application through the FDA's approval process. Two, Dr. Rushton will work to complete additional research for the company's Very Low Nicotine smoking cessation c i g a r e t t e , X - 2 2 . S u b s e q u e n t l y , h e will prepare a submission to the FDA for X-22 to be authorized as a p r e s c r i p t i o n s m o k i n g c e s s a t i o n treatment. Three, lastly, Dr. Rushton will work to ensure that 22nd Century is one of the world's foremost leaders in sponsored research on the cannabis plant with the objectives of producing low/no THC strains for use in hemp production and high CBD strains for use in the medical marijuana markets." We asked Sicignano about cannabis a p p l i c a t i o n s a n d i f t h e c a n n a b i s genome been fully mapped and how important an area of interest cannabis is for XXII. " T h e c a n n a b i s g e n o m e i s sequenced, though the sequencing does appear to have gaps," Sicignano s a i d . " I n a d d i t i o n , t h e a s s e m b l y of the sequencing is problematic. However, we do have a nice starting point for future cannabis research. The company intends to be the world leader in cannabis research through its ongoing research partnership with Annandia Laboratories in Canada. As you note, the company's technology with tobacco is far more mature. With tobacco, 22nd Century has extensive genome research, viable plant varieties, overwhelming data from clinical trials showing efficacy, impending Modified Risk—reduced exposure—commercial products, and current commercial products." Finally, we asked Sicignano about how he deals with regulatory issues and whether measuring success for a tobacco company is just a matter of doing the best one can. " W h i l e s u c c e s s f u l l y n a v i g a t i n g regulatory issues does impact 22nd Century greatly, the company is not simply following the path of least resistance," Sicignano said. "Instead, the company seeks to introduce its products where they will accomplish the most good—the United States, A s i a a n d E u r o p e a r e i m p o r t a n t markets for 22nd Century as evidenced b y o u r e f f o r t s i n c l u d i n g : M R T P application to the FDA for MRTP approval of BRAND A in the United S t a t e s , t h e e x p a n s i o n o f M A G I C d i s t r i b u t i o n i n E u r o p e , a n d t h e c o m p a n y ' s c o n t i n u i n g w o r k t o introduce its tobaccos in Asia." TURN OF THE XXII CENTURY The staff at the 22nd Century Group are not only devoted to reducing the harm caused by smoking–they're also a handsome lot. Dr. Paul Rushton, Ph.D., vice president of Plant Biotechnology at XXII Century Group.

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