22nd Century Announces Strategic Hire to Facilitate FDA Applications for Modified Risk Tobacco Product Candidates
September 08 2015 - 8:59AM
Business Wire
New addition brings design and
commercialization experience with multiple FDA regulated
products
22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco
harm reduction, announced today the appointment of Gregg M. Gellman
as the Company’s Director of Business Development and Regulatory
Affairs. Hired for his experience in achieving FDA compliance
approval for various types of products, Mr. Gellman will be tasked
with driving 22nd Century’s regulatory affairs strategies for the
Company’s two modified risk cigarettes in development: “BRAND A,”
the world’s lowest nicotine tobacco cigarette, and “BRAND B,” the
world’s lowest tar-to-nicotine ratio cigarette.
Throughout his career, Mr. Gellman has worked intimately with
the FDA to ensure products in his charge are designed and tested to
be compliant with all FDA regulations. As a development and medical
device manager at Greatbatch, Inc. (NYSE: GB), Mr. Gellman managed
the design process and commercialization of multiple FDA-regulated
products. Mr. Gellman has also proven himself an innovator in the
development of new products and has amassed extensive experience in
technical and clinical sales training for products ultimately
approved by the FDA. Mr. Gellman is a graduate of the State
University of New York at Buffalo and is certified in Quality
Systems for Medical Devices (FDA’s QSR and ISO 13485) and in Global
Product Submissions Directive Requirements (510(k), PMA, CE
Mark).
“Hiring Gregg Gellman represents another important step in 22nd
Century’s mission to bring reduced exposure cigarettes to American
smokers,” explained Henry Sicignano, III, CEO and President.
“Unlike some of our larger competitors, who market their products
with implied health claims, 22nd Century is committed to working
collaboratively with the FDA to demonstrate that our Very Low
Nicotine cigarettes and our Low Tar-to-Nicotine Ratio cigarettes
are legitimate – and enormously important – modified risk tobacco
products.”
Aiming to become the first company in the world authorized by
the FDA to market reduced exposure combustible cigarettes, 22nd
Century intends to submit its application for “BRAND A” to the FDA
this fall. At the same time, because regulatory pre-approval is not
required to label Very Low Nicotine cigarettes outside of the
United States, the Company will expand distribution of its MAGIC
0 Very Low Nicotine cigarettes in Europe. As sufficient funds
are secured for additional exposure studies, the Company intends to
submit in 2016 an application to the FDA for “BRAND B.”
22nd Century’s 185 issued patents make possible the Company’s
two modified risk cigarettes in development. Without a license from
22nd Century, no other company can grow, make, or buy 22nd
Century’s proprietary Very Low Nicotine tobacco (95% less nicotine
content than conventional tobacco), or 22nd Century’s proprietary
Very High Nicotine tobacco leaf that will make possible “BRAND B,”
the world’s lowest tar-to-nicotine ratio cigarette.
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants through genetic engineering and plant
breeding. The Company’s mission is to reduce the harm caused by
smoking. 22nd Century currently owns or exclusively controls more
than 185 issued patents and more than an additional 54 pending
patent applications around the world. The Company’s strong IP
position led to a licensing agreement with British American Tobacco
(“BAT”), the world’s second largest tobacco company.
Visit www.xxiicentury.com for more information.
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
year ended December 31, 2014, filed on February 6, 2015, 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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version on businesswire.com: http://www.businesswire.com/news/home/20150908005974/en/
For 22nd Century Group, Inc.Investor Relations:Andrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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