Hercules Pharma granted rights to license 22nd Century's X-22 smoking cessation aid

Oct 31 2011

22nd Century Group, Inc. (OTCBB: XXII), a company focused on smoking cessation and tobacco harm reduction products, announced today that the company licensed Hercules Pharmaceuticals LLC, its wholly-owned pharmaceutical subsidiary, exclusive worldwide rights to X-22.

X-22, a smoking cessation aid in development under an Investigational New Drug Application at the U.S. Food & Drug Administration (FDA), consists of a kit of very low nicotine (VLN) cigarettes containing 22nd Century's proprietary tobacco. X-22 cigarettes contain 97% less nicotine than Marlboro^® Gold, the U.S. cigarette market leader, formerly known as Marlboro Lights^®. Results of 22nd Century's X-22 randomized, double-blind, active-controlled, multicenter, Phase II-B clinical trial will be announced in December 2011.

Separately, The New York Times reported on Saturday in an article authored by Duff Wilson titled, Cigarettes Are Enlisted to Test Ways of Quitting, that 22nd Century supplied the National Institute on Drug Abuse (NIDA), a department of the National Institutes of Health (NIH), with 450,000 packs (9,000,000 cigarettes) of SPECTRUM^® cigarettes. SPECTRUM^® is solely for research purposes, contains various levels of nicotine, and will not be sold as a commercial cigarette. The article also summarized X-22 and one of the company's potential "modified risk" tobacco products.

In an effort to facilitate global distribution of X-22, Hercules Pharmaceuticals has also been granted exclusive worldwide rights to license 22nd Century's technology and products, which are patented in more than 70 countries. Hercules Pharmaceuticals will concentrate on expanding market opportunities for X-22. Joseph Pandolfino, founder and CEO of 22nd Century, explained, "We have commenced a search for a Chief Executive Officer with vast international experience to operate and manage Hercules Pharmaceuticals."