|By Business Wire||
|June 11, 2014 01:40 PM EDT||
22nd Century Group, Inc. (NYSE MKT:XXII) today announced that on June 9, 2014 the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance to the Company for technology that reduces nicotine in tobacco by suppressing expression of the NBB gene by itself and in combination with other nicotine biosynthesis genes.
There are various commercial applications of the NBB technology, including producing cigarettes with various nicotine levels, from very low to high. The Company expects to use very low nicotine cigarettes produced with the NBB technology for a modified risk application to be filed with the U.S. Food and Drug Administration. Many studies have been carried out with the Company’s proprietary very low nicotine cigarettes. A recently published independent clinical trial (Vogel et al. 2014), concluded, “Very low nicotine content (VLNC) cigarettes lead to a reduction in the number of cigarettes smoked, toxicant exposure, withdrawal symptoms and dependence.”
U.S. Patent Application Number 11/579,661, Reducing Levels of Nicotinic Alkaloids in Plants, and related International Patent Application PCT/IB2006/001741, cover methods for producing tobacco plants with decreased nicotine levels and tobacco plants and products produced therefrom. The patent will be granted by the USPTO shortly, and upon grant the USPTO will convey to the Company a Patent Term Adjustment, which is expected to extend the expiration date beyond February 28, 2026.
The NBB gene encodes a protein, “nicotine synthase,” that is involved in the final step of nicotine biosynthesis. Having eluded scientists for decades, this protein can be down-regulated or up-regulated to produce tobacco varieties with a wide range of nicotine levels. International Patent Application PCT/IB2006/004043 covers methods for producing tobacco plants with increased nicotine levels with the NBB technology and tobacco plants and products produced therefrom. Patent applications for the NBB technology have been filed by 22nd Century on a worldwide basis and patents are currently issued to 22nd Century in China, Japan, Taiwan, Mexico, Australia and South Africa. Patents will also soon be granted to 22nd Century for the NBB technology in the United Kingdom, Ireland, Germany, France, Italy, Spain, Poland, Switzerland and Turkey.
Dr. Takashi Hashimoto of the Nara Institute of Science and Technology (NAIST), a world-renowned plant molecular biologist, is an inventor of the NBB technology. 22nd Century funded research and development at NAIST from 2005 to 2009, and in 2010 NAIST assigned various patent families to 22nd Century, including the NBB patent families.
The Company’s vice president of research and development, Dr. Michael Moynihan stated, “The NBB gene technology is one of the keystones of 22nd Century’s intellectual property and represents our second-generation gene technology that has significant advantages over our earlier technology.” Specifically, the sole function of NBB is to produce nicotine and other nicotinic alkaloids.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company whose proprietary technology allows for the levels of nicotine and other nicotinic alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco plant to be decreased or increased through genetic engineering and plant breeding. 22nd Century owns or is the exclusive licensee of 116 issued patents in 78 countries plus an additional 42 pending patent applications. Goodrich Tobacco Company, LLC and Hercules Pharmaceuticals, LLC are wholly-owned subsidiaries of 22nd Century. Goodrich Tobacco is focused on commercial tobacco products and potentially less harmful cigarettes. Hercules Pharmaceuticals is focused on X-22, a prescription smoking cessation aid in development.
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 22nd Century Group, Inc., 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 annual report on Form 10-K for the fiscal year ended December 31, 2013, filed on January 30, 2014, including the section entitled “Risk Factors,” and our other reports filed with the U.S. 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.
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