22nd Century Group Engages CRO for FDA Regulatory Activities of Company’s Modified Risk Cigarettes
July 11 2014 - 12:44PM
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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In 2012, the FDA issued Draft Guidance on Modified Risk Tobacco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.
Redington, Inc.Tom Redington, 203-222-7399
22nd Century (AMEX:XXII)
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