Vaccine breaks out of the pack

Smokers have tried a long list of ways to quit: cold turkey, counseling, gum, patches.

Now a small company is hoping to make millions of dollars by creating a vaccine for people who want to kick the habit.

Nabi Biopharmaceuticals of Rockville, Md., which is in the late stages of testing its experimental vaccine, took a big step toward its goal last week by striking a deal with pharmaceutical giant GlaxoSmithKline.

Under the agreement, GlaxoSmithKline will pick up the cost of developing and marketing the vaccine, 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 containing diminishing 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 a smoker can't get a buzz from smoking a cigarette, the thinking goes, there's no reason to continue the habit. Because the antibodies created by NicVax stay in the body a long time, the chances of a smoker quickly backsliding are low.

“It breaks the cycle of addiction,” said 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.

Creating a vaccine against a small nicotine molecule is a large challenge, said Norman Edelman, chief medical officer of the American Lung Association. “At first blush,” he said, “it sounds crazy — but it's not beyond the realm of belief.”

Cheryl Healton, president and CEO of the American Legacy Foundation, a public health nonprofit, said it's the long-term effects of NicVax as a smoking cure that make it revolutionary. Smokers don't usually manage to quit on the first try. On average, there are eight to 11 failed attempts, she said.

Under the terms of the deal with GlaxoSmithKline, Nabi will receive $40 million initially for the exclusive worldwide licensing rights to the drug. The company stands to make as much as $500 million from the deal with GSK if the company 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.

Though 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 federal Centers for Disease Control and Prevention found that 20.6 percent of U.S. adults count themselves as smokers, a figure that's virtually unchanged from 2004, when it was 20.9 percent.

Nabi isn't the only firm trying to defeat the smoking habit with this type of vaccine. An experimental drug from Swiss pharmaceutical firm Novartis and Cytos Biotechnology recently failed a middle round of testing, casting doubts on it reaching the market.

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