Novartis has acquired the exclusive worldwide rights to a novel development compound from Cytos Biotechnology AG that combines elements of medicinal and vaccine technology and has been shown in clinical trials to help smokers overcome their addiction to nicotine.
Phase II trials have indicated that this potentially first-in-class vaccine, called CYT002-NicQb has the potential to promote abstinence from smoking in patients who achieved high antibody levels following vaccination. A subsequent study determined the optimal dose for future trials, and this compound is set to enter phase III trials in late 2008.
Novartis acquired the worldwide development, manufacturing and commercialisation rights to NicQb to strengthen its portfolio of medicines to help patients with respiratory diseases such as asthma and the smoking-related chronic obstructive pulmonary disease (COPD).
"This unique compound complements our efforts to provide a range of new treatment options to patients and physicians across a wide range of respiratory diseases," said Thomas Ebeling, CEO of Novartis Pharma AG. "Smoking remains a cause of many fatal diseases, and vaccine technology represents an important new approach to help people overcome their addiction to nicotine and stop smoking permanently."
NicQb is one of several therapeutic vaccines being developed by Cytos using its Immunodrug technology. Instead of building antibodies to destroy infections like traditional vaccines, these compounds train the immune system to produce antibodies to prevent or treat chronic diseases.
Another Novartis developmental compound, CAD106, was acquired from Cytos in 2001 as a vaccine therapy for Alzheimer's disease and is currently in phase I clinical trials.
NicQb acts by inducing the body to develop antibodies - a class of blood proteins generated by the immune system - that bind specifically to nicotine molecules in the bloodstream. The resulting complex is too large to cross the blood-brain barrier, significantly reducing the uptake of this highly addictive substance and preventing the so-called "nicotine high," a form of stimulation that can cause a significant failure rate in people attempting to quit smoking.
Developing effective and sustainable treatments to help those wanting to stop smoking is critical given World Health Organization estimates that more than 1.3 billion people smoke and that tobacco use remains the world's leading cause of death. Smoking is believed to cause more than 80% of deaths from lung cancer and COPD.
Almost 75 per cent of smokers report that they want to stop but less than 5 per cent are successful, according to a 2004 report from the US Surgeon General. This low success rate is often blamed on data showing that nicotine is a highly addictive substance and that a withdrawal syndrome appears in patients when tobacco use is stopped characterized by irritability, anger, impatience, and insomnia.