Cypress Bioscience, Inc. announced that it has licensed Alexza Pharmaceutical's Staccato nicotine technology - a novel electronic multidose delivery technology designed to help people stop smoking. The innovative Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, thus mimicking the actual nicotine effects of smoking without the deleterious side effects associated with cigarettes.

According to the terms of the agreement, Cypress will pay Alexza an upfront payment of $5 million to acquire the worldwide license for the Staccato nicotine technology. In addition, following the completion of certain clinical milestones relating to the Staccato nicotine technology, Cypress will be obligated to pay to Alexza an additional technology transfer payment of $1 million. Alexza will have a carried interest of 10 per cent (subject to adjustment in certain circumstances) in the net proceeds of any sale or license by Cypress of the Staccato nicotine assets and the carried interest will be subject to put and call rights in certain circumstances.

Jay D. Kranzler, MD, PhD, chairman and chief executive officer of Cypress Bioscience, said, "We are pleased to expand our CNS pipeline with this novel Staccato nicotine technology. The electronics embedded within the Staccato delivery system allow for the programmed, over-time reduction of nicotine intake, and may ultimately lead to better management of nicotine cravings and sustained smoking cessation. Given that the vast majority of smokers trying to quit using existing therapies relapse within six months, we see great potential in this novel technology and we are excited about this transaction."

Kranzler continued, "Today's announcement demonstrates continued progress on our strategic plan to acquire and develop innovative CNS therapeutics that have the potential to address important unmet medical needs. Developing novel therapies such as effective nicotine replacement technology is consistent with our renewed focus on CNS drug development. We expect to take this technology into phase 1 clinical trials in late 2011."

Neal Benowitz, MD, Professor of Medicine, Bioengineering & Therapeutic Sciences, University of California, San Francisco, and a specialist in nicotine addiction and smoking cessation, said, "A pulmonary nicotine delivery device, like Staccato nicotine, may be useful in addressing a pressing pharmacological problem in overcoming nicotine addiction; namely, that acute cravings during quit attempts are inadequately treated by current nicotine replacement therapies. A device that provides for rapid absorption of nicotine, combined with electronic controls to adjust doses to facilitate tapering and cessation, is an advancement that the field has been waiting for."

Despite decades of public health and medical intervention, smoking remains one of the most preventable causes of death in the United States. Smoking continues to exact a staggering toll on human health, claiming more than 430,000 lives annually in the US One in five deaths in the US are attributable to smoking related illness. While the vast majority of smokers indicate an interest in quitting, approximately 80 per cent of smokers who try to quit on their own relapse in one month, and only 3 per cent will remain abstinent at six months. Current nicotine replacement therapies (nasal, buccal and transdermal), nicotinic agonists, and other prescription therapies approximately double the rates of abstinence as compared to placebo, but even so the vast majority of smokers using these treatments relapse within six months. The scientific community has called for the development of a pulmonary nicotine delivery system that more closely mimics the blood levels of nicotine produced through smoking, as such a system could be differentially effective in helping smokers to quit.

Staccato nicotine is designed to help smokers quit by addressing both the chemical and behavioural components of nicotine addiction by combining nicotine replacement via inhalation with a user-friendly drug delivery device. The Staccato technology may be capable of mimicking the pharmacokinetics of smoking cigarettes through the delivery of optimally-sized nicotine particles to the deep lung. Staccato nicotine may also provide some of the psychological aspects of smoking (e.g., hand-to-mouth movement, oral inhalation) and could allow smokers to self-administer and possibly titrate to the dose to treat cravings. Importantly, the electronics embedded within the Staccato delivery system could allow for the programmed, over-time reduction in the overall daily dose of nicotine, and ultimately may lead to the better management of nicotine cravings and eventual sustained smoking cessation.

Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.

Cypress Bioscience is a pharmaceutical company dedicated to the development of innovative drugs targeting large unmet medical needs for patients suffering from a variety of disorders of the central nervous system.