PETERSBURG, Va. -- Star Scientific Inc. said its board has approved a reorganization of the company's corporate structure to provide for a separation of its core businesses: tobacco manufacturing operations, principally in the area of 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 Star Tobacco's operations to its shareholders, which include the manufacturing, distribution and sales of 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 use certain monoamine oxidase (MAO) agents in tobacco that the company said can be used 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 Food & Drug Administration (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 contract research firm Quintiles Transnational Inc.
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.
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 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 will continue the company's intellectual property pursuits, it said, including the patent litigation against RJ Reynolds Tobacco Co. It also will sublicense the technology to its new subsidiary to facilitate the drug development efforts.
The board of the new subsidiary will include Paul L. Perito, Star Scientific's chairman, president and COO. Perito served as chief counsel and deputy director of the White House Special Action Office on Drug Abuse Prevention 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, 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.