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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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