US: 22 Century Group Gets Order for Research Cigarettes

Source from:  Winston-Salem (NC) Journal 09/21/2015

A biotechnology company with a Mocksville operation, 22nd Century Group Inc., said Friday that a subsidiary has received an order for nearly 5 million cigarettes that are being produced in cooperation with four federal health agencies.

22nd Century, based in Clarence, N.Y., said the latest request for Spectrum cigarettes, made by subsidiary Goodrich Tobacco Co., raises the overall order total to more than 22 million cigarettes.

22nd Century opened operations in Mocksville in 2014 through acquiring the production equipment used by defunct Renegade Tobacco Inc. Goodrich makes Spectrum, as well as Red Sun and Magic super premium brands, at the plant.

Spectrum cigarettes are not sold commercially. They are produced from proprietary and patented technology for exclusive use in clinical research.

Federal agencies involved in Spectrum research include the Food and Drug Administration, National Institute on Drug Abuse, National Cancer Institute and the Centers for Disease Control and Prevention.

Spectrum contains 24 styles that vary in nicotine yields from very low (97 percent less nicotine than conventional brands) to relatively high nicotine yields. There are regular and menthol flavors.

"We are very proud to be a part of such important public health nicotine research efforts and at the forefront of reduced exposure cigarette product development," the company said in a statement.

Among research categories are:

·Comparing how different nicotine levels in cigarettes affect smoking behavior and exposure to smoke compounds

·Smoking cessation

·Determining whether there is a threshold nicotine level in cigarettes that does not produce dependence.

22nd Century officials say their goal is "to become the first company in the world authorized by the FDA to market reduced exposure combustible cigarettes." The company has a licensing agreement with British American Tobacco Ltd.

In June, 22nd Century said the publication Nicotine & Tobacco Research accepted a study of a Phase 2 clinical trial related to smoking cessation products.

The company said the clinical trial at Queen Mary University of London explored the efficacy of its proprietary very-low-nicotine tobacco as a smoking cessation aid when combined with pharmaco therapy. Queen Mary researchers said 22nd Century's very-low nicotine cigarettes proved to be satisfying to smokers and helped to reduce tobacco withdrawal symptoms.

In September 2014, 22nd Century spent $1 million in cash and stock to buy NASCO Products LLC, which was operated by Ralph Angiuoli Sr., a former president and chief executive of R.J. Reynolds Tobacco Co.

Buying NASCO gave 22nd Century access to NASCO's license as a participant in the landmark 1998 Master Settlement Agreement, key to getting wholesalers and vendors to carry and sell their tobacco products.

In 2001, 22nd Century formed a partnership with Vector Tobacco Inc., which produced cigarette products known as Quest as a smoking-cessation aid. After three years of clinical trials, Vector stopped pursuit of FDA approval for the product. 22nd Century retained the clinical trial learnings.

Bill Godshall, executive director of SmokeFree Pennsylvania, said he is skeptical of 22nd Century's ability to sell a very low nicotine product whose taste will attract smokers.

"Trying to pave the way for FDA to mandate nicotine reductions in cigarettes, our federal government is spending taxpayer dollars buying and studying cigarettes that smokers don't want and won't buy," he said. Enditem