GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction

In a press release dated November 16, 2009, GlaxoSmithKline Biologicals announced a licensing agreement for a nicotine conjugate candidate vaccine (NivVax®), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.

This is exciting news for those who want to quite smoking but find it difficult to do so.

NicVax has recently entered the first of two Phase 111 clinical trials.

“If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent; a habit that is well documented to be very hard to stop permanently” said Jean Stephenne, President of GSK Biologicals. “This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio.”

Tobacco use is the leading cause of preventable death in the world. Smoking is a global epidemic, affecting an estimated 1.2 billion smokers worldwide and is responsible for 5.4 million deaths per year worldwide. Nicotine dependence is a chronically relapsing condition with only a minority of smokers achieving permanent abstinence in the first attempt to quit. Tobacco has been recognized by the Royal College of Physicians as being on par, from an addictive standpoint, with heroin and cocaine and as such, many tobacco users need support to stop.

Smoking is the number one cause of Chronic Obstructive Pulmonary Disease (COPD). More than 90 percent of COPDs are caused by smoking, cigarette or otherwise. About 30 percent of long term smokers will eventually show symptoms of COPD of varying degrees. Other causes include air pollution and inherited enzyme deficiency namely alpha-1 antitrypsin deficiency.

COPD is also the number one cause of lung transplantation. Often, when I'm talking with COPD patients who are on oxygen and waiting for a lung transplant the say "Why did I ever start smoking? Why?". Here's a breakdown of the main causes for a lung transplant:

• 27% chronic obstructive pulmonary disease or COPD, including emphysema;


• 16% idiopathic pulmonary fibrosis;


• 14% cystic fibrosis;


• 12% idiopathic (formerly known as "primary") pulmonary hypertension;


• 5% alpha 1-antitrypsin deficiency;


• 2% replacing previously transplanted lungs that have since failed;


• 24% other causes, including bronchiectasis and sarcoidosis.

I sure hope that NicVax turns out to be a viable product that results in a drop in smoking rates. Right now, 45 million Americans are smokers. As the press release notes, smoking is a global epidemic, affecting an estimated 1.2 billion smokers worldwide and is responsible for 5.4 million deaths per year worldwide.

The vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products.

Pre-clinical and clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes the candidate vaccine could also be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers. Currently available smoking cessation therapies have relapse rates that can be as high as 90% in the first year after a smoker quits. (Medscape Medical News reports that at present the Nicotine Patch Plus Lozenge is the Best Therapy for Smoking Cessation.)

Read the full press release.

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