CLARENCE, N.Y. - Wednesday, November 2nd 2011 [ME NewsWire]
(BUSINESS WIRE)-- 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 reportedon Saturday in an article authored by Duff Wilsontitled, 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.”
About 22nd Century Group, Inc.
Founded in 1998, 22nd Century Limited, LLC, (22nd Century) a wholly-owned subsidiary of 22nd Century Group, Inc., is a plant biotechnology company whose proprietary technology allows for the level of nicotine (and other nicotinic alkaloids) in the tobacco plant to be decreased or increased through genetic engineering and breeding. 22nd Century owns or is the exclusive worldwide licensee of 99 issued patents in 79 countries where at least 75% of the world’s smokers reside. We are committed to developing and commercializing (i) the world’s most effective and acceptable smoking cessation aid and (ii) for those smokers who refuse to quit smoking, consumer-acceptable modified risk tobacco products that reduce exposure to smoke toxins, as compared to conventional cigarettes.
For additional information, please visit: www.xxiicentury.com
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the company, its directors or its officers with respect to the contents of this press release. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements.
We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our prospectus dated September 20, 2011, including the section entitled “Risk Factors,” and our reports filed with the Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
Contacts
Redington, Inc.
Tom Redington,
203-222-7399
CEOcast, Inc.
Jim Fallon,
212-732-4300
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