Star Scientific, Rock Creek Pharmaceuticals Present at FDA Advisory Subcommittee Meeting
GLEN ALLEN, Va., June 10 /PRNewswire-FirstCall/ — Star Scientific, Inc. (Nasdaq: CIGX) issued the following statement today from Paul L. Perito, the company’s Chairman and President:
Curtis Wright, MD, MPH, Senior Vice President and Ryan Lanier, Ph.D., of Rock Creek Pharmaceuticals, made a presentation on tobacco toxins on Tuesday June 8 to the FDA Tobacco Products Scientific Advisory Subcommittee on Tobacco Product Constituents. This subcommittee of the agency’s Tobacco Products Scientific Advisory Committee (TPSAC) was formed to assist with the FDA’s congressional mandate to publish a list of harmful constituents found in tobacco products, and the levels found in each product, within two years after passage of the June 2009 Family Smoking Prevention and Tobacco Control Act.
The FDA published a request for comments on this topic in July 2009. Dr. Wright, in his capacity as a technical and scientific advisor to Star Scientific, and I, submitted written comments on tobacco toxin labeling to the FDA on September 17, 2009. Tuesday’s presentation focused on the well-known and researched carcinogens found in tobacco; the reality that adult tobacco users have the right to make informed choices about the tobacco products they use; and that if it is possible to reduce or remove a known carcinogen in tobacco, companies have an obligation to do so.
We are gratified that the FDA, in addressing the harmful constituents that are found in tobacco, is focusing on these issues, which were outlined ten years ago in the 2000 Surgeon General’s report:
As with all other consumer products, adult users of tobacco should be fully informed of the products' ingredients and additive and of any known toxicity when used as intended. Additionally, as with other consumer products, the manufactured tobacco product should be no more harmful than necessary given available technology.
A body of peer-reviewed literature has made it clear for almost a decade that there are significant differences in the levels of carcinogens found in tobacco products due to variations in curing and manufacturing practices. A landmark study in the journal Tobacco Control by Gray et. al. showed up to 9-fold differences in carcinogen levels in the same cigarette brands and a recent article from the CDC in Cancer, Epidemiology, Biomarkers & Prevention reports that lowering the levels of the carcinogen NNK in the mainstream smoke of cigarettes through the use of specific tobacco types and known curing practices can significantly affect the exposure of smokers to this known carcinogen It is our hope that the FDA will both publish a list of the toxicants and carcinogens that are well documented to be linked with tobacco harm, and also will require tobacco product manufacturers to include the levels of these toxins on product packaging.
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”), 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.
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 as filed with the SEC on March 16, 2010, 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 company with a mission to reduce the harm associated with tobacco at every level. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins, principally through the utilization of the innovative StarCuredÃ‚® tobacco curing technology. Through its Rock Creek Pharmaceuticals subsidiary it is also involved in the development of nutraceuticals as well as products to address neurological and mood disorders. Star Scientific has a Corporate and Sales Office in Glen Allen, VA, an Executive, Scientific & Regulatory Affairs office in Bethesda, MD, and a manufacturing facility in Chase City, VA. Rock Creek has scientific and research offices in Gloucester, MA. and a regulatory office in Washington, D.C.
See Star’s website at: http://www.starscientific.com
Contact: Sara Troy Machir Vice President, Communications & Investor Relations email@example.com (301) 654-8300
SOURCE Star Scientific, Inc.