Star Scientific Files Application with FDA for Ariva-BDL(TM) Approval as First Modified Risk Tobacco Product
February 22 2010 - 9:39AM
PR Newswire (US)
GLEN ALLEN, Va., Feb. 22 /PRNewswire-FirstCall/ -- Star Scientific,
Inc. (NASDAQ:CIGX) announced that on Friday, February 19 the
company filed an application with the Food & Drug
Administration for approval to market Ariva-BDL(TM) as a "modified
risk" tobacco product under the Family Smoking Prevention and
Tobacco Control Act of 2009. This submission is the first such
application to be filed with the Tobacco Products Center of the
FDA, which has been established to oversee all aspects of tobacco
regulation outlined in the 2009 Act. (Logo:
http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO )
Ariva-BDL(TM), a dissolvable tobacco lozenge with wintergreen
flavoring, is made with flue-cured tobacco that contains levels of
tobacco-specific nitrosamines (TSNAs) that are below detectable
limits ("BDL") by most current standards of measure. TSNAs have
been identified in scientific literature since the early 1950s as
one of the most deadly and abundant groups of carcinogens in
tobacco and its smoke. Achieving this reduction, known within Star
as "ZNT" (zero-nitrosamine tobacco) was accomplished by new work on
the StarCured® tobacco curing technology that originally was
developed in the 1990s. This innovation is the subject of a patent
application filed in December 2008. A recent article by Rickert et
al. (Regulatory Toxicology and Pharmacology 2009;53(2):121-33)
reported total TSNA levels in currently marketed popular moist
snuff and "pouch" tobacco products that ranged from 8,814 - 14,557
parts per billion. This range is 1000 times greater than the levels
measured in Ariva-BDL(TM), as outlined in the company's submission.
Star Scientific believes these developments are of great
significance in light of the reality that 43 million Americans --
roughly half of them women -- smoke each day. More than half of
this population is looking for an acceptable alternative to
cigarettes. Cigarette revenues in the United States currently total
$75 - $80 billion, according to the Wall Street Journal. While a
number of male smokers in the US now use traditional smokeless
tobacco as an alternative to smoking, female smokers do not accept
the unpleasant aesthetics of using moist snuff. As a completely
dissolvable lozenge, Ariva-BDL(TM) would offer a useful alternative
-- with greatly reduced toxin levels -- to adult smokers of both
genders. Star Scientific originally introduced dissolvable
smokeless tobacco to the marketplace almost ten years ago when it
launched Ariva® in 2001, and Stonewall Hard Snuff® in 2003. Both
products are pieces of powdered and compressed StarCured® tobacco
that dissolve completely in the mouth and leave no residue. Ariva®,
launched in 2001, was developed for adult dependent smokers who
cannot or choose not to smoke. Stonewall Hard Snuff®, launched in
mid-2003, is an alternative for adults who use traditional
smokeless tobacco products or who identify themselves as "heavy
smokers". Over the past nine years the company has learned that
Ariva® customers range in age from 30 - 70, and more than half of
whom are women. Stonewall Hard Snuff® purchasers range in age from
25 - 65. Customers who are looking for an alternative to moist
snuff are largely male, while roughly 30 - 40% of those who
purchase the products as an alternative to "heavy" daily cigarette
smoking are female. According to callers to the product consumer
call center, the majority of purchasers are concerned about
continued smoking. Both Ariva and Stonewall are available with
wintergreen flavoring, which have been the blend most often
purchased by Star's customers. Ariva® and Stonewall® were the
subjects of a federally funded pilot study published last month in
Nicotine & Tobacco Research that was conducted at the Medical
Center of South Carolina. The two-week study involved recruiting
smokers uninterested in quitting cigarettes who randomly were
either given Ariva® or Stonewall®, or continued smoking cigarettes.
The data analysis revealed that among the Ariva/Stonewall group
there was a 40% reduction in cigarettes smoked per day, and
"significant increases in two measures of readiness to quit, either
in the next month or within the next six months. No such changes
were found among smokers maintained on conventional cigarettes".
When Star had the opportunity to read the published study, the
company's management team was gratified by this new information but
did not consider the authors' conclusions unexpected. The
independent Scientific Advisory Board that provided input on
tobacco-related research to Star directed the company's attention
to a body of research indicating that smoking rates among Swedish
men (17.9%) were probably among the lowest in the developed world,
a dramatic reduction from much higher smoking rates (36%) twenty
years before. During the intervening two decades a transition in
tobacco use occurred: 20% of Swedish men were now users of snus,
Swedish smokeless tobacco that contained reductions in TSNAs.
Epidemiological studies concluded in the period 1998 - 2001 found
no increase in head or neck cancers, while lung cancer deaths had
fallen, among Swedish men. The company believes that Ariva-BDL(TM),
if approved, will be highly attractive to other companies. For this
reason, Star has committed to exploring opportunities for
sublicensing agreements with both domestic and international
entities, so that Ariva-BDL(TM) can be made available as broadly as
possible to adult dependent smokers. This press release contains
certain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Star Scientific,
Inc. and its consolidated subsidiaries ( collectively, the
"Company") has tried, whenever possible, to identify these
forward-looking statements using words such as "anticipates",
"believes", "estimates", "expects", "plans", "intends" and similar
expressions. These statements reflect the Company's current beliefs
and are based upon information currently available to it.
Accordingly, such forward-looking statements involve known and
unknown risks, uncertainties and other factors which could cause
the Company's actual results, performance or achievements to differ
materially from those expressed in, or implied by, such statements.
These risks, uncertainties and contingencies include, without
limitation, the challenges inherent in new product development
initiatives, the uncertainties inherent in the progress of
scientific research, the Company's ability to raise additional
capital in the future necessary to maintain its business, potential
disputes concerning the Company's intellectual property, risks
associated with litigation regarding such intellectual property,
potential delays in obtaining any necessary government approvals of
the Company's low-TSNA tobacco products, market acceptance of the
Company's new smokeless tobacco products, competition from
companies with greater resources than the Company, the Company's
decision not to join the Master Settlement Agreement ("MSA"), and
the Company's dependence on key employees and on its strategic
relationships with Brown & Williamson Tobacco Corporation in
light of its combination with RJ Reynolds Tobacco Company, Inc.
Although the Company believes the expectations reflected in such
forward-looking statements are based on reasonable assumptions, it
can give no assurance that the expectations will be attained or
that any deviation will not be material. See additional discussion
under "Risk Factors" in the Company's Quarterly Report on Form 10-K
as filed with the SEC on March 16, 2009, and other factors detailed
from time to time in the Company's other filings with the SEC,
available at http://www.sec.gov/. All information in this release
is current as of this date, and the Company undertakes no
obligation to update or advise upon any such forward-looking
statements to reflect events or circumstances after the date of
this press release or to reflect the occurrence of unanticipated
events. About Star Scientific Star Scientific is a
technology-oriented company with a mission to reduce the harm
associated with tobacco at every level. It is engaged in the
development of dissolvable smokeless tobacco products that deliver
fewer carcinogenic toxins, principally through the utilization of
the innovative StarCured® tobacco curing technology. Through its
Rock Creek Pharmaceuticals subsidiary it is also involved in the
development of nutraceuticas as well as products to address
neurological and mood disorders. Star Scientific has a Corporate
and Sales Office in Glen Allen, VA, an Executive, Scientific &
Regulatory Affairs office in Bethesda, MD, and a manufacturing
facility in Chase City, VA. Rock Creek has scientific and research
offices in Gloucester, MA. and a regulatory office in Washington,
D.C. See Star's website at: http://www.starscientific.com/ Contact:
Sara Troy Machir Vice President, Communications & Investor
Relations (301) 654-8300
http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO
http://photoarchive.ap.org/ DATASOURCE: Star Scientific, Inc.
CONTACT: Sara Troy Machir, Vice President, Communications &
Investor Relations, Star Scientific, Inc., +1-301-654-8300, Web
Site: http://www.starscientific.com/
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