1998
Star Announces New Management Team As
CigRx
MovesCloser to Market.
PETERSBURG, Va.--(BUSINESS WIRE)--Oct. 20, 1998--Star Tobacco & Pharmaceuticals, Inc. ("Star"), a wholly owned subsidiary of Eye Technology, Inc. (OTC BB: EYTC), announced today that the initial patent claims protecting the novel process for producing tobacco virtually free of all tobacco specific
nitrosamines ("TSNA's"), which are the most powerful and abundant carcinogens in tobacco and second-hand smoke/1, have been issued by the U.S. Patent & Trademark Office (Patent No. 5,803,081).
Additional claims directed to this unique technology are presently pending before the U.S. P&TO, as well as in approximately 80 industrialized countries. The Company is an exclusive licensee of that protected technology.
The Board at its Friday meeting announced that it has expanded and restructured its senior management team in order to respond to the broadening focus of Star's most significant potential role, i.e., supplying tobacco, processed by using Star's newly patented method, to virtually eliminate or reduce to undetectable levels the tobacco specific nitrosamines to tobacco companies on a worldwide basis.
In that vein, the Board has named Malcolm L. "Mac" Bailey, presently a director of the Company, as its new President. Mr. Bailey is the second largest tobacco grower in the Commonwealth of Virginia and the owner and President of Golden Leaf Tobacco Company in Keysville, Va., a tobacco leaf dealer. Mr. Bailey is President of S&M Brands, Inc., a small manufacturer of cigarette products. In addition to his private business activities, Mr. Bailey is President of the Virginia Agricultural Grower's Association, a trade association which includes approximately 85% of flu-cured tobacco farms in Virginia.
Dr. Robert DeLorenzo, Chairman of the Board, stated: "Mac Bailey brings a wealth of knowledge concerning all facets of tobacco growing and processing and the workings of the tobacco leaf marketplace. He has worked with the Company management for several years and has been an important contributor to the development of the Company's proprietary tobacco processing methods to reduce carcinogenic nitrosamines in tobacco." Dr. DeLorenzo has agreed to assume the expanded additional role of CEO.
The Board also selected a 27 year veteran of public accounting with vast experience in business valuation, auditing and accounting as its Chief Financial Officer. James A. McNulty, CPA, CVA has assumed the responsibilities of CFO effective immediately.
Given the future role to be played by targeted education regarding adult choice for smoking and/or cessation products, the Board believed that it would be greatly assisted if it could find an educational administrator, with a legal background, who could be of assistance to the Board and Company as it sorts its way through the complex issues which surround the area of adult choice and the ways in which young people can be more effectively convinced not to embrace smoking as a way of life. The Board has found its ideal candidate.
The Board Chairman, Dr. DeLorenzo (Professor and Chairman of the Department of Neurology of Virginia Commonwealth University), has announced that Leo Sampson Tonkin, Esquire, a distinguished graduate of Johns Hopkin University and the Harvard Law School (Class of 1962) and founder of the nationally acclaimed Washington Workshops Foundation, has accepted the position as an independent director on the Board. Mr. Tonkin, at an early stage in his career, served as both a House and Senate counsel to Committees chaired by former Congressman and Senator Charles "Mac" Mathias, Jr. of Maryland. In three generations at the helm of the Workshops, Mr. Tonkin and the Foundation have been responsible for bringing over 50,000 students from all walks of life into Washington to understand the functioning of the federal government. Some of its graduates are Members of Congress and senior government officials.
Mr. Tonkin has been Chairman of the Board of Trustees of St. Aquinas College, as well as a member of the Board of Trustees of Immaculata College, Washington, DC. The Washington Workshops has been honored by being named the recipient of the Americanism Award by the Valley Forge Freedom Foundation, among other honors it has received.
The Board also named Jonnie R. Williams, a co-founder of Star and a co-inventor of the patented process exclusively licensed to the Company, to the positions of Executive Vice President and COO. Further, the Board accepted the resignation of David P. Sheets, former President, CEO and a director.
In addition, the Company announced it just completed the planned Phase I study of Star's CigRx product at the Medical College of Virginia (MCV) under the direction of Dr. William Barr, Chairman of Pharmaceutics, as principal investigator. The 19-day crossover study was carried out under an FDA reviewed protocol at the Center for Drug Studies at the Virginia Commonwealth University and MCV. The CigRx cigarettes used in the study are made from pure Virginia tobacco cured by Star's patented curing process.
The CigRx cigarettes used in the study were developed from tobaccos specially processed by using Star's patented method which tobacco has been tested for over two years by the University of Kentucky organic chemist, Dr. Harold Burton, a long-time professor at the University. Dr. Burton is widely recognized as an expert in tobacco science.
CigRx tobacco used in the recently completed study has virtually no detectable tobacco specific nitrosamines, while the nicotine levels (about 1 milligram per cigarette) were comparable to full-flavored cigarettes. However, CigRx cigarettes delivered substantially less carbon monoxide (4.8 milligrams versus 12.2 milligrams) and about half as much tar (7.0 milligrams versus 14.0 milligrams) compared to an average of the best selling full-flavored cigarettes, as measured by the FTC recognized method.
Male and female volunteers participated in the 19-day crossover study which was conducted on an in-patient, as well as out-patient, basis. Subjects smoked their regular brand or CigRx for nine days, after which time they were admitted to an in-patient research unit for three days. While in the research unit, their diet was controlled and they were carefully observed, with their breath levels measured for carbon monoxide and blood levels for nicotine. Urine specimens were obtained to measure tobacco specific nitrosamines which will be independently tested by the American Health Foundation. Dr. Barr expects data analysis to be completed within the next 3-4 months.
The Company believes that its proprietary, high-speed process for reducing to a minimal or virtually undetectable level the tobacco specific nitrosamines in the tobacco leaf will be able to be made available, in significant quantities, to tobacco, as well as smokeless tobacco, companies during next year's growing season. The Company believes it has the ability to deliver its technology in an economically feasible manner so that it can respond to large scale anticipated demands for processed tobacco in next year's harvest. The sophisticated machinery is being manufactured by Amana Corporation under a 15-year exclusive agreement. Significant funds have been expended to reach this point in the Company's development where it has been able, in this growing season, to deliver tobacco for testing to multiple cigarette and tobacco product companies. Star's proprietary high speed process does not affect taste, color or the nicotine content of the tobacco leaf.
ST&P believes that all presently-marketed cigarettes and smokeless tobacco products pose a range of potential health consequences which mandated the Company to commit funds and scientific resources to examine ways in which tobacco could be made available as a knowing choice to the adult population in a less harmful delivery system.
Dr. DeLorenzo, as a long-time medical educator and researcher, strongly believes that it is only by "good science" and continued research that the Company will ultimately be able to assist tobacco growers and producers in producing less hazardous and reduced risk tobacco consumer products.
This press release contains certain forward-looking statements, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform of 1995. Investors are cautioned that forward-looking statements necessarily involve risks and uncertainties which may affect the Company's business and prospects.
Forward-looking statements are based upon current management expectations. These statements may differ materially from actual future events, as a result of certain risks and uncertainties, including, but not limited to, risks associated with the development, manufacture and commercialization of Star's proprietary process for reducing or virtually eliminating tobacco-specific nitrosamines in the processing of the tobacco leaf as well as risks associated with the Company's CigRx product including potential delays in obtaining any necessary federal and/or state regulatory approvals, market acceptance of CigRx cigarettes, general economic conditions and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and current reports on Form 8-K.
Source: Star Tobacco & Pharmaceuticals, Inc., a wholly owned subsidiary of EyeTech.
/1 These toxic compounds, according to Doctors B. Spiegelhalder and H. Bartsch of the German Cancer Research Center in Heidelberg, Germany, "are the most abundant carcinogens in tobacco, as well as in tobacco smoke." See also, Clinical Reviews in Toxicology, Vol. 26, Issue No.2, 1996, Special Issue, Tobacco-Specific N-Nitrosamines: Recent Advances edited by Roger O. McClellan, CRC Press, Inc
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