An experimental vaccine aimed at shutting down nicotine’s access to the brain is at the centre of a pharmaceutical deal
SMOKERS HAVE tried a long list of ways to quit: cold turkey, counselling, gum, patches and more.
Now, a small company is hoping it can make millions by creating a vaccine for people who want to kick the habit.
Nabi Biopharmaceuticals of Rockville, Maryland, in the US, which is in the late stages of testing its experimental vaccine, took a big step toward its goal late last month by striking a deal with pharmaceutical giant GlaxoSmithKline.
Under the agreement, GlaxoSmithKline will pick up the cost of developing and marketing the vaccine, called NicVax, if Nabi successfully completes the Phase 3 trials now under way.
For many years, the standard treatment for breaking a smoker’s dependence on nicotine has been patches or gum that contain declining dosages of the substance in an effort to wean addicts off their dependence.
Nabi’s experimental vaccine, a decade in the works, tries a more direct approach: it shuts down nicotine’s access to the brain. Smokers may light up a cigarette while on NicVax, but if the drug works as intended, they won’t feel any of the stimulating effects they crave from nicotine.
NicVax causes the immune system to create antibodies that bond with the nicotine molecule if it enters the bloodstream. The result is a molecule too large to pass along to the brain. In short, the vaccine seeks to make the body immune to nicotine.
If smokers can’t get a buzz from lighting up a cigarette, the thinking goes, there’s no reason for them to continue the habit.
Since the antibodies created by NicVax stay in the body for a long period of time, the chances of a smoker quickly returning to the habit are low.
“It breaks the cycle of addiction,” says Raafat Fahim, Nabi president and chief executive.
So far, the vaccine has completed its early and middle rounds of testing. The company plans to have the results of its recently commenced final round in 2011.
“At first blush, it sounds crazy,” says Norman Edelman, chief medical officer of the American Lung Association. After all, creating a vaccine against a small nicotine molecule is a large challenge, he says, “but it’s not beyond the realm of belief”.
Cheryl Healton, president and chief executive of the American Legacy Foundation, a public health non-profit organisation, says it’s the long-term effects of NicVax as a smoking cure that make it revolutionary. Smokers don’t usually quit successfully on the first try. On average, there are eight to 11 failed attempts, she says.
Under the terms of the deal with GlaxoSmithKline, Nabi will receive $40 million (€26 million)initially for the exclusive worldwide licensing rights to the drug. The company stands to make as much as $500 million (€333 million) from the deal if it meets a number of developmental and marketing milestones in the coming years. That figure doesn’t include royalties the company would earn if the product makes it to market.
“Needless to say, I’m very pleased with the agreement with GlaxoSmithKline, which provides not only for the development and potential commercialisation of NicVax, but also for the development of its second-generation nicotine vaccines,” Fahim says.
While the percentage of adults who use tobacco has been on a steady decline over the past few decades, recent years have seen that trend flatten out.
Last year, the US Centers for Disease Control and Prevention found that 20.6 per cent of US adults count themselves as smokers, a figure that’s virtually unchanged since 2004, when it was 20.9 per cent.
Nabi isn’t the only firm trying to defeat the smoking habit with this type of vaccine, but it appears to have a head start on the competition, says Stephen Dunn, managing director of life science research at Jesup Lamont.
An experimental drug from Swiss pharmaceutical firm Novartis and Cytos Biotechnology recently failed a middle round of testing, casting doubts on whether it will reach the market. – (LA Times/Washington Post)
