Star Scientific : Star Scientific Announces Intent to Pursue Drug Development
06/25/2007| 08:00am US/Eastern

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Star Scientific, Inc. (NASDAQ: STSI) announced today approval by the
company's board of directors to reorganize the
company's corporate structure to provide for a
separation of its core businesses: tobacco manufacturing operations,
principally in the area of very low-TSNA dissolvable smokeless tobacco
products; and intellectual property and new-product development
operations, including pharmaceutical products that use a botanical
tobacco component. The long-term objective of this initiative is to
position the company so that it can consider spinning off to its
shareholders Star Tobacco's operations, which
include the manufacturing, distribution and sales of the very low-TSNA
dissolvable smokeless products, Ariva® and
Stonewall®.
The company recently incorporated a new subsidiary in Delaware. The
subsidiary will be the vehicle for the company's
pursuit of a range of tobacco-based pharmaceutical products, including
products for the treatment of smokeless tobacco dependence, as well as
products that would utilize certain monoamine oxidase (MAO) agents in
tobacco to treat a range of neurological conditions, including Alzheimer's
disease, Parkinson's disease, schizophrenia
and depression.
Star's interest in exploring and developing
tobacco-based pharmaceutical products for smokeless and inveterate
smoking therapy, and ultimately cessation, began in the mid-1990s. At
that time, the company's predecessor, Star
Tobacco & Pharmaceuticals, committed resources to researching and
developing two tobacco-based pharmaceutical products through
investigatory new drug applications (INDs) filed with the FDA. Those
products, made using low-TSNA tobacco, were for smokers to use as
cessation aids when other methods had not been successful. The process
was facilitated by Quintiles Transnational, Inc., the largest contract
research organization in the United States. Christopher Chapman, MD, now
a member of the Star Scientific board of directors, at that time was the
Senior Director of Medical Affairs at Quintiles.
The company's tobacco manufacturing
operations, which include Ariva® and
Stonewall Hard Snuff® low-TSNA dissolvable
tobacco products, are conducted through Star Tobacco, Inc., a
TTB-licensed manufacturer. That subsidiary will continue to manufacture
and sell the company's dissolvable smokeless
tobacco products, and any other low-TSNA tobacco products that it
develops in the future.
Star's interactions with the FDA regarding
the IND process were a significant factor in its decision to advocate
publicly for equitable and rational jurisdiction over all tobacco
products by the FDA. Star's board of
directors unanimously endorsed these efforts in a July, 1999 policy
statement, which stated in part, ?Star
Scientific is committed to working with the public health community, the
FDA and other federal regulatory agencies?in
the scientific development of products that have the potential for
lessening or even eliminating the incidence of disease, death and
addiction associated with tobacco use.?
Star Scientific, Inc. will continue the company's
intellectual property pursuits, including the patent litigation against
RJ Reynolds Tobacco Company. It also will sublicense the technology to
its new subsidiary to facilitate the drug development efforts.
The Board of Directors of the new subsidiary will include Paul L.
Perito, Star Scientific's Chairman, President
and COO. Mr. Perito served as Chief Counsel and Deputy Director of the
White House Special Action Office on Drug Abuse Prevention (?Drug
Czar?) from 1971 to 1973, and during his
legal career and in his role with Star Scientific, he has been involved
in the company's efforts to develop tobacco
technology that have pharmaceutical applications. The directors also
will include Christopher C. Chapman, Jr., MD. Dr. Chapman is a Director
of Star Scientific and CEO of Chapman Pharmaceutical Consulting Inc. The
company is in the process of conducting a search for a clinical/medical
director who would oversee future clinical trials and the development of
tobacco-related pharmaceutical products.
This press release contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. 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, particularly in the smokeless tobacco area, 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"), the effect
of state statutes adopted under the MSA and any subsequent modification
of the 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. The
impact of potential litigation, if initiated against or by individual
states that have adopted the MSA, could be materially adverse to the
Company.
See additional discussion under "Factors That May Affect Future Results"
in the Company's Form 10-K for the year ended December 31, 2006, as
filed with the SEC on March 16, 2007, as amended by its Form 10-K/A
filed with the SEC on April 30, 2007, and other factors detailed from
time to time in the Company's other filings with the Securities and
Exchange Commission, available at www.sec.gov.
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 tobacco company with a toxin
reduction mission. It is engaged in the development of dissolvable
smokeless tobacco products that deliver fewer carcinogenic toxins
(principally tobacco specific nitrosamines, or TSNAs), through the
utilization of the innovative StarCured®
tobacco curing technology, and in sublicensing that technology to
others. Star Scientific has a Corporate and Sales Office in Petersburg,
VA, an Executive, Scientific & Regulatory Affairs office in Bethesda,
MD, and manufacturing and tobacco processing facilities in Chase City,
VA and in Petersburg, VA.
See Star's website at: http://www.starscientific.com
Star Scientific, Inc.
Sara Troy Machir, 301-654-8300
Vice
President, Communications & Investor Relations
smachir@starscientific.com
© Business Wire 2007
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