Pharmaceutical Technologist - January 2008 - (Page 6)

News Promising development of nicotine addiction vaccine ave you made a New Year’s resolution to stop smoking? A proprietary vaccine could soon be on its way to help. NicVAX(R), developed by Nabi Biopharmaceuticals to treat nicotine addiction and prevent smoking relapse, has completed its Phase IIb trial, with promising results, and could have a significant impact on how patients are treated. The vaccine stimulates the immune system to produce antibodies that bind to nicotine and prevent it from crossing the blood-brain barrier, blocking it from receptors in the brain that cause the highly-addictive pleasure experienced by smokers and users of nicotine products. “I believe data from this trial are very encouraging — for smokers who are trying to quit as well as for the field of smoking cessation vaccines,” says Dr Stephen Rennard, one of the trial’s lead investigators. “Only a short time ago, it was difficult to find convincing evidence to link antinicotine antibodies with smoking cessation. This double-blind, placebo-controlled trial has H demonstrated a clinical proof of concept. The data shows a correlation between antibody level and the ability of patients to quit smoking and remain abstinent over long periods of time.” The rate of smoking cessation and the ability to achieve long-term abstinence in patients treated with the vaccine was correlated with the level of antinicotine antibodies at critical time points. The high antibody responder group (top 30% of antibody responders) showed continuous abstinence rates almost three times longer than those of the placebo group at 12 months. In addition, patients in the NicVAX(R) group who continued to smoke, but had a high antibody response, showed a statistically significant reduction in the number of cigarettes smoked during the full 12 months. Importantly, there was no evidence of compensatory smoking or increase in withdrawal symptoms observed in NicVAX(R) patients at any stage of the trial. They continued to show comparable adverse event profiles to the placebo at each stage of the study. Dr Leslie Hudson, chief executive officer of Nabi, says: “We will use these encouraging final data to advance our NicVAX(R) partnership discussions and to determine the optimal design for the next step in our clinical trial efforts for this important primary care product candidate.” www.nabi.com Significant increase in European HIV infection rates IV infection in the EU has nearly doubled since 1999, and has become a priority for the European Centre for Disease Prevention and Control (ECDC). According to the EuroHIV survey in 2006, 26220 new cases of HIV were diagnosed across the continent (data excludes Italy and Spain). The majority of cases were found in males (66%), but 11% were among people aged 15–24 years. The significant amount of new cases could be caused by an increase in testing rates among HIV infected persons; an increase in the number of persons becoming infected in Europe; an increase in the number of HIV infected persons migrating to Europe; or a combination of all of these factors. The level H and nature of the epidemic and its implications for public health vary across Europe. The countries with the highest rates of new infections per million inhabitants include Estonia (504.2), Portugal (205) and the UK (148.8). In response to its significantly high levels of infection, Estonia has made several efforts to tackle its epidemic, and the ECDC has pledged to support the country in a number of areas including surveillance, sharing country experiences and providing European guidance on HIV testing. However, there is a growing need for all of Europe to address the problem of HIV. ECDC estimates that approximately 30% of people living with the disease are unaware they are infected, and so are less likely to take precautions against transmitting the virus and are also unable to access treatment. The survey believes that the standardization of the HIV surveillance system needs to be improved at a European level to enhance comparability of European data, and to ensure the monitoring of adequate data with which to develop policies for the prevention, control and treatment of HIV. In 2008, the ECDC will be working to identify and confront potential barriers to HIV testing, and hopes that higher testing rates across Europe will link more HIV infected people to prevention and treatment services. www.ecde.eu.int 6 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST http://www.nabi.com http://www.ecde.eu.int

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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