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22nd Century Group Engages CRO for FDA Regulatory Activities of Company’s Modified Risk Cigarettes
|By Business Wire
|July 11, 2014 12:44 PM EDT
22nd Century Group, Inc. (NYSE MKT: XXII)
announced today that it has engaged a major a contract research
organization (“CRO”) with extensive experience in tobacco exposure
studies to assist the Company in certain regulatory activities at the
Center for Tobacco Products (“CTP”) of the U.S. Food and Drug
Administration (“FDA”) related to the Company’s research to support the
development of potentially less harmful or modified risk cigarettes.
The CRO will prepare meeting requests and meeting information packages
to be submitted to the CTP, including protocols for clinical exposure
studies to be carried out in the fall of 2014 on one of the Company’s
potential modified risk cigarette candidates in development. The CRO
will also assist 22nd Century in the execution of the FDA meetings and
follow-up regulatory activities. 22nd Century expects to engage the CRO
to carry out the subject exposure studies as well.
Dr. Michael Moynihan, Vice President of Research and Development at 22nd
Century Group, stated, “We are pleased to have selected this CRO, which
has extensive experience in conducting clinical exposure studies for the
tobacco industry, to lead our regulatory efforts related to our
potential modified risk cigarettes.”
Considering there are approximately 1 billion smokers worldwide, Forbes
magazine recently characterized a “safer cigarette” as follows: “A
product that could have the biggest impact on human health since the
introduction of antibiotics.”
The 2009 Family Smoking Prevention and Tobacco Control Act (“Tobacco
Control Act”) requires the FDA to evaluate modified risk
(potentially less harmful) tobacco products. Upon demonstrating
compelling scientific evidence that 22nd Century’s cigarettes (i) reduce
exposure to tobacco toxins and (ii) are reasonably likely to pose lower
health risks as compared to leading brands, the advantages of a modified
risk cigarette may then be conveyed to consumers through labeling and
marketing of the product – pursuant to the statutory requirements of the
Tobacco Control Act.
In 2012, the FDA issued Draft
Guidance on Modified Risk Tobacco Product Applications and has since
issued additional guidance. The FDA’s guidance provides the framework
for applicants to submit data for modified risk product candidates.
Goodrich Tobacco Company, 22nd Century’s subsidiary, is developing two
types of modified risk cigarette candidates.
As previously reported, the FDA requested to have a meeting with 22nd
Century to discuss the Company’s proprietary products. 22nd Century met
with the FDA on June 17, 2013. Subsequently, in the fourth quarter of
2013, our subsidiary, Goodrich Tobacco, sold 2,500 kilograms of its
proprietary very low nicotine (“VLN”) tobacco to the FDA as a
subcontractor under a government contract. The Company plans to continue
to work with the FDA on other contracts.
Separately, due to a New York Stock Exchange scheduling conflict on July
15, 2014, 22nd Century Group will now celebrate its recent listing on
the NYSE MKT by ringing the closing bell at the Exchange on Thursday,
October 16, 2014.
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 117 issued
patents in 78 countries plus an additional 44 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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