22nd Century Group Engages CRO for FDA Regulatory Activities of Company''s Modified Risk Cigarettes

Source from:  CBS MarketWatch  07/14/2014

22nd Century Group, Inc. (NYSE MKT: XXII ) announced today that it has engaged a major a contract research organization ("CRO") with extensive experience in tobacco exposure studies to assist the Company in certain regulatory activities at the Center for Tobacco Products ("CTP") of the U.S. Food and Drug Administration ("FDA") related to the Company's research to support the development of potentially less harmful or modified risk cigarettes.

The CRO will prepare meeting requests and meeting information packages to be submitted to the CTP, including protocols for clinical exposure studies to be carried out in the fall of 2014 on one of the Company's potential modified risk cigarette candidates in development. The CRO will also assist 22nd Century in the execution of the FDA meetings and follow-up regulatory activities. 22nd Century expects to engage the CRO to carry out the subject exposure studies as well.

Dr. Michael Moynihan, Vice President of Research and Development at 22nd Century Group, stated, "We are pleased to have selected this CRO, which has extensive experience in conducting clinical exposure studies for the tobacco industry, to lead our regulatory efforts related to our potential modified risk cigarettes."

Considering there are approximately 1 billion smokers worldwide, Forbes magazine recently characterized a "safer cigarette" as follows: "A product that could have the biggest impact on human health since the introduction of antibiotics."

The 2009 Family Smoking Prevention and Tobacco Control Act (" Tobacco Control Act ") requires the FDA to evaluate modified risk (potentially less harmful) tobacco products. Upon demonstrating compelling scientific evidence that 22nd Century's cigarettes (i) reduce exposure to tobacco toxins and (ii) are reasonably likely to pose lower health risks as compared to leading brands, the advantages of a modified risk cigarette may then be conveyed to consumers through labeling and marketing of the product – pursuant to the statutory requirements of the Tobacco Control Act.

In 2012, the FDA issued Draft Guidance on Modified Risk Tobacco Product Applications and has since issued additional guidance. The FDA's guidance provides the framework for applicants to submit data for modified risk product candidates. Goodrich Tobacco Company, 22nd Century's subsidiary, is developing two types of modified risk cigarette candidates.

As previously reported, the FDA requested to have a meeting with 22nd Century to discuss the Company's proprietary products. 22nd Century met with the FDA on June 17, 2013. Subsequently, in the fourth quarter of 2013, our subsidiary, Goodrich Tobacco, sold 2,500 kilograms of its proprietary very low nicotine ("VLN") tobacco to the FDA as a subcontractor under a government contract. The Company plans to continue to work with the FDA on other contracts.

Separately, due to a New York Stock Exchange scheduling conflict on July 15, 2014, 22nd Century Group will now celebrate its recent listing on the NYSE MKT by ringing the closing bell at the Exchange on Thursday, October 16, 2014. Enditem