PETERSBURG, Va., Sept. 22 /PRNewswire-FirstCall/ -- Star Scientific, Inc. (Nasdaq: STSI) makers of low-nitrosamine smokeless tobacco products, announced today that the company will utilize a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December, 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured(R) curing process: the International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star's products. The company believes that this novel process, as reflected in its patent application, will enable the company to achieve the lowest toxin levels anywhere in the world. Star plans to submit the products to the FDA for approval to market as "modified risk" tobacco products, under Section 911 of the new Family Smoking Prevention and Tobacco Control Act, once formulation and testing of the new product is completed in early 2010.
Curtis Wright, MD, MPH, Chief Medical Officer for Rock Creek Pharmaceuticals, Star Scientific's pharmaceutical division, commented, "I am excited to see how low the nitrosamine content of this new material will be once it is processed and formulated." Laboratory testing of some of the tobacco leaf samples after curing has revealed levels for NNN and NNK, the most lethal forms of TSNAs, below ten parts per billion. These values are comparable to NNN and NNK levels found in several nicotine replacement therapy products (NRT) as reported by a University of Minnesota research team in December, 2007.
Late last week Star Scientific submitted comments to the FDA in response to the agency's request for input on the regulatory framework established by the Family Smoking Prevention and Tobacco Control Act, which was signed into law by President Obama in June, 2009. The company's comments, which can be viewed at http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a2524f, focus on the need for tobacco product labeling that lists the levels of the most lethal carcinogens in the products in a way that is clear to adult tobacco users. Paul L. Perito, Star's chairman and president commented that "Adult tobacco users need to have access to information about the spectrum of harm associated with tobacco use in order to be able make informed choices about the products they purchase." Mr. Perito added that he hopes clear and accurate labeling will be one of the cornerstones of tobacco regulation policy.
The company also formally nominated Dr. Wright for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation. In a letter submitted to the agency on September 21, the company pointed out that "Dr. Wright has an enormous breadth of experience in the area of addictive substances, and eight years of his career were spent at the Food & Drug Administration. . .Dr. Wright can contribute not only as a scientist, but also as an executive with significant industry experience. "
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"), the effect of state statutes adopted under 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.
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 Annual Report on Form 10-K for the year ended December 31, 2008, 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 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(R) 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 facilities in Chase City, VA.
About Rock Creek Pharmaceuticals
Rock Creek Pharmaceuticals develops pharmaceutical products for treatment of addiction and other neurological disorders. The company supports third-party academic, educational and therapeutic advances in both these areas of research. Rock Creek has scientific and research offices in Gloucester, MA.
See Star's website at: http://www.starscientific.com
Contact: Sara Troy Machir Vice President, Communications & Investor Relations firstname.lastname@example.org (301) 654-8300
|SOURCE Star Scientific, Inc.|
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