MEDIA RELEASE PR38492
Star Scientific Files Application with FDA for Ariva-BDL(TM) Approval as First
Modified Risk Tobacco Product
GLEN ALLEN, Va., Feb. 25 /PRNewswire-AsiaNet/ --
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.
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(R) 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(R) in 2001, and
Stonewall Hard Snuff(R) in 2003. Both products are pieces of powdered and
compressed StarCured(R) tobacco that dissolve completely in the mouth and
leave no residue. Ariva(R), launched in 2001, was developed for adult
dependent smokers who cannot or choose not to smoke. Stonewall Hard Snuff(R),
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(R) customers
range in age from 30 - 70, and more than half of whom are women. Stonewall
Hard Snuff(R) 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(R) and Stonewall(R) 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(R) or Stonewall(R), 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 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(R) 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.
Contact:
Sara Troy Machir
Vice President, Communications & Investor Relations
smachir@starscientific.com
(301) 654-8300
SOURCE: Star Scientific, Inc.
CONTACT: Sara Troy Machir,
Vice President,
Communications & Investor Relations,
Star Scientific, Inc.,
+1-301-654-8300,
smachir@starscientific.com
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