TA-NIC

Nicotine Dependence

TA-NIC is a novel and proprietary vaccine in development as an aid to quitting smoking in motivated patients. TA-NIC is an immunotherapeutic vaccine similar in concept to TA-CD, designed to raise anti-nicotine antibodies. The antibodies bind to nicotine molecules in the patient's blood stream, reducing the rate and quantity of nicotine entry into the brain and thus reducing the positive reinforcement and addiction associated with nicotine and cigarette smoking. It is expected that the reduction of the positive reinforcement will in turn reduce the desire to smoke or use other tobacco products.

Treatment with TA-NIC is expected to be part of a comprehensive smoking cessation management program that includes other supportive measures.

TA-NIC completed a Phase I-II study in 120 smoking patients, and is expected to enter a larger Phase II study in the US in 2007. TA-NIC is expected to be filed with the FDA 2009.

Market

Tobacco use is the second major cause of death in the world, and the leading cause of preventable death in the US. In the US and EU, there are over 140 million smokers, of which a significant portion are attempting to quit. An estimated 70% of smokers in the US want to quit, but only 2.5% per year succeed in quitting permanently despite the known health risks. According to the US Centers for Disease Control and Prevention, approximately 45 million adults and 6 million teenagers in the US smoke, triggering an estimated $75.5 billion in excess medical costs and another $81.9 billion in mortality-related productivity losses each year. Despite widespread knowledge of tobacco's dangerous health effects, smoking continues to pose a serious public health threat, and there is a clear and large unmet demand for more effective anti-smoking products.