22nd Century awarded $244,000 QTDP program grant

Nov 8 2010

22nd Century Limited, LLC, a company focused on smoking cessation and tobacco harm reduction products, announced that it has been awarded $244,000 in grant funding as part of the U.S. Government's Qualifying Therapeutic Discovery Project (QTDP) program. Proceeds from the grant will be used to support clinical trials for 22nd Century's prescription product candidate, X-22, a smoking cessation kit containing very low nicotine ("VLN") cigarettes made from the company's proprietary tobacco, which has 95% less nicotine compared to tobacco in existing "light" cigarettes.

"The QTDP grant provides recognition of 22nd Century's novel and promising approach to the large unmet medical need for smoking cessation therapies," said Dr. Michael Moynihan, Vice President of Research and Development. Independent studies, including phase II clinical trials, have demonstrated that VLN cigarettes made from 22nd Century's proprietary tobacco facilitate quitting by satisfying smokers' cravings for cigarettes while (1) greatly reducing nicotine exposure and nicotine dependence, and (2) extinguishing the association between the act of smoking and the rapid delivery of nicotine.

Both the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) agree that smoking is the leading cause of preventable death in the U.S. and the world. The available choices of FDA-approved smoking cessation aids in the U.S. are nicotine replacement therapy (NRT) products (gums, patches, nasal sprays, inhalers and lozenges) and 2 non-nicotine prescription pills, Chantix^® (varenicline) and Zyban^® (bupropion). Both Chantix^® and Zyban^® were required by the FDA in 2009 to carry a boxed warning highlighting the risk of serious mental health events.

22nd Century expects, upon FDA approval, that X-22 will be more attractive to smokers than other therapies since X-22 smokes and tastes like a typical cigarette, involves the same smoking behavior, and does not expose smokers to new drugs or new side effects. Joseph Pandolfino, 22nd Century's CEO, stated, "Smokers currently have few choices of approved pharmacotherapies: nicotine (NRT), which a large percentage of smokers have already tried and failed to quit smoking, and 2 non-nicotine prescriptions which have a boxed warning."

Approximately half of the 46 million adult smokers in the U.S. attempt to quit each year and it takes smokers an average of 8 to 11 quit attempts before achieving long-term success. 22nd Century believes that a user-friendly prescription product like X-22, upon FDA approval, will greatly increase quit attempts and therefore reduce the number of smokers.

"Since X-22 is the only smoking cessation aid that functions exactly as a regular cigarette, we believe our product will expand the smoking cessation market by encouraging more smokers to attempt to quit," Mr. Pandolfino stated. He added, "The math is simple, more quit attempts lead to fewer smokers."